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nasdaq:annx
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www.annexonbio.com
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app.trinethire.com
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Nov 27th, 2020 12:00AM
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Associate Director/Director, Program & Portfolio Management
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Open
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180 Kimball Way, Suite 200, South San Francisco, CA, United States of America
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180 Kimball Way, Suite 200, South San Francisco
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CA
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USA
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Associate Director/Director Program & Portfolio ManagementPosition OverviewThe Associate Director/Director Program & Portfolio Management is a proactive and effective problem solver who is intellectually curious and works exceedingly well with others. This role is responsible for managing and driving cross-functional activities required to advance a program from preclinical development through BLA submission. The winning skill set includes working effectively and efficiently with cross- functional groups including nonclinical, clinical, technical development, regulatory, manufacturing, commercial planning and finance. As a key member of the Core Team, the Associate Director/Director, Program & Portfolio Management will work closely with the GPL (Global Program Leader) to help establish and execute program strategy and activities, integrate cross-functional input, synthesize team recommendations, and ensure program advancement on time and on budget. Lastly, the Director, Program & Portfolio Management is expected to create and maintain consistent project documentation including project plans, timelines, trackers and communications. Specific Responsibilities· In partnership with GPL and Core Team, develops and maintains integrated product development and lifecycle plans.· Creates and maintains project timelines that are critical tools for tracking progress against goals; closely and transparently manages the critical path of the project.· Proactively identifies critical milestones, interdependencies, risks and resource constraints that could impact project timelines and collaborates with teams to develop appropriate solutions.· Co-facilitates Core Team Meetings with GPL.· Responsible for Core Team documentation including meeting agendas, minutes, action item and decision trackers.· Ensures that all team members are fully informed and knowledgeable of project activities and status; optimizes communication within and between teams, in and outside of meetings.· Partners with Core Team to proactively address acute issues that arise.· Ensures that consistent project management tools and practices are used across team.· Supports continuous improvement efforts in Project Management practices at Annexon; leads department initiatives.· Ensures compliance with corporate policies and procedures, as well as, US healthcare laws and regulations.Position Qualifications· Undergraduate degree in a scientific, medical or business discipline; postgraduate qualification (e.g., Ph.D., MBA, MS) or commensurate experience is a distinct advantage.· A minimum of 8 years of biopharmaceutical industry experience, with half in a Project Management function supporting highly matrixed drug development teams comprised of, but not limited to, functional area representatives from Research, CMC, Regulatory, Clinical, Marketing and Finance.· Solid understanding of activities critical to early and late stage drug development projects; commercial-stage a plus.· Proven ability to manage complex, cross-functional development projects with Go/No Go decisions.· Well-versed at scenario planning and capable of rapidly integrating new information into existing plans.· Excellent meeting planning and facilitation skills.· Highly proficient at both building and maintaining Gantt charts, tracking systems, spreadsheets and tools that support a systematic and scalable approach to managing projects.· Highly organized, excellent writing and oral communication skills, motivated and analytically rigorous.· Experienced at partnering with team members to determine planning assumptions that drive timelines and budgets.· Adept at skillfully managing complex and challenging situations.· Team-oriented, with excellent interpersonal skills (i.e. collaboration, conflict management and negotiation).
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Nov 27th, 2020 03:46PM
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Nov 27th, 2020 03:46PM
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Annexon Biosciences
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nasdaq:annx
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www.annexonbio.com
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app.trinethire.com
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Nov 27th, 2020 12:00AM
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Director, Financial Planning & Analysis
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Open
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180 Kimball Way, Suite 200, South San Francisco, CA, United States of America
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180 Kimball Way, Suite 200, South San Francisco
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CA
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USA
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Company Summary
Annexon Biosciences is a clinical-stage biopharmaceutical company
developing a pipeline of novel therapies for patients with classical
complement-mediated disorders of the body, eye and brain. The Company’s
pipeline is based on its platform technology addressing well-researched
classical complement-mediated autoimmune and neurodegenerative disease
processes, both of which are triggered by aberrant activation of C1q, the
initiating molecule of the classical complement pathway. The Company’s first
product candidate, ANX005, is a full-length monoclonal antibody formulated for
intravenous administration in autoimmune and neurodegenerative disorders. The
Company’s second product candidate, ANX007, is a monoclonal antibody
antigen-binding fragment (Fab) formulated for intravitreal administration for
the treatment of neurodegenerative ophthalmic disorders. Based on learnings
from its initial trials, Annexon is advancing its current programs while
evaluating additional orphan and large market indications. Annexon is deploying
a disciplined, biomarker-driven development strategy designed to establish that
each of its product candidates is engaging the specific target at a
well-tolerated therapeutic dose in the intended patient tissue.
Desired Candidate Profile
The FP&A Director is a high impact,
executive-facing role that will report directly to the VP, Controller, and support
Annexon’s critical pipeline milestones, as well as the company’s growth toward becoming
a multi-product commercial-stage biopharmaceutical company. The FP&A Director
will have a key role in supporting multiple functional areas and project teams
within the Annexon organization. The role will have the unique opportunity to build
and work on budgets for various stages within the clinical development process
across the Annexon portfolio. This role
will partner closely with leaders across clinical operations, manufacturing,
and project management to drive the annual budget process, regular forecasts as
well as the long- range plan. Success in
this role will require cultivating partnerships across teams, strong
communication, ability to influence, and strategic thinking skills to drive
value to the business.
Specific ResponsibilitiesPartner with stakeholders to coordinate and develop annual budget and periodic forecasts, including OPEX, capital spend and headcount.Work with project management organization to leverage external data to understand and challenge expense projections for short- and long-term financial models.Work closely with department heads to review complex clinical and manufacturing contracts for costs and payment terms during the contract negotiation.Collaborate with cross-functional leaders to create monthly reporting dashboard to track key financial and performance metrics. Perform budget versus actual analysis at the consolidated, project, and department levels to identify and understand variances, assess associated risks and opportunities, and communicate results to senior management.Perform assessment FP&A system requirements and near-term implementation to support needs of the organization.Support adhoc requests as needed. Provide financial assessments and guidance for strategic projects and business cases. Develop and deliver presentations to senior management with clear and concise objectives, analyses, and recommendations.Key Qualifications:Bachelor’s degree in finance or accounting required. CPA and/or MBA preferred. Minimum of 8-10 years of increasing responsibility in finance or accounting. Professional experience in a biotechnology, pharmaceutical, or medical device organization.Prefer experience in company with late stage development or commercial stage products. Ability to establish strong business relationships and interact cross-functionally at all levels.Must possess strong problem-solving skills. Ability to work effectively to identify issues, gather relevant data points and recommend solutions.Must be a strong communicator capable of explaining/presenting complex financial concepts and problems clearly and effectively to all constituents. Customer service oriented; able to understand business requirements while maintaining ownership for projects and results.Highly detail oriented with strong analytical skills; experienced in developing financial models, leading analysis, and explaining options and implications.Highly motivated self-starter capable of working under pressure and prioritizing workload to meet deadlines. Strong team player with ability to demonstrate executive presence.Process and systems improvement mindset for creating solutions to problems that work across boundaries beyond this role.
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Nov 27th, 2020 03:46PM
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Nov 27th, 2020 03:46PM
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Annexon Biosciences
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nasdaq:annx
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www.annexonbio.com
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app.trinethire.com
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Nov 28th, 2020 12:00AM
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Head of Clinical Biomarkers
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Open
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180 Kimball Way, Suite 200, South San Francisco, CA, United States of America
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180 Kimball Way, Suite 200, South San Francisco
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CA
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USA
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Head of Biomarkers The Head of Biomarkers is responsible for developing and implementing strategies for clinical biomarkers
across the entire Annexon discovery and development portfolio. This strategy is critical to Annexon’s
precision medicine approach in the key therapeutic areas of Autoimmune diseases, Neuroscience and
Ophthalmology. This individual will serve as an important Annexon leader and integrator between
research and development. He/she will also oversee operational aspects such as the collection and
analysis of all clinical biosamples and interfacing with external vendors to obtain timely and high-quality
data.
Responsibilities
• Develop biomarker strategies to enable precision medicine approaches and optimal selection of
patient indication and patient subsets in clinical trials.
• Develop biomarker strategy to align the clinical development plan from Phase I to III.
• Supervise biomarker assay development, validation and implementation.
• Lead operations for collection, management and analysis of clinical trial patient biomarker
samples.
• Develop biomarker analysis plan and oversee biomarker data analysis; leads the analysis of
biomarkers for clinical studies by working with key internal stakeholders and external CROs as
needed.
• Provide consultation to pre-clinical programs to drive formulation of biomarker strategy at an
early stage of development.
• Responsible for the integration of scientific learnings and clinical biomarker data to define
targeted patient populations and enable selection of potential diagnostic platforms.
• Provides expert guidance to multi-disciplinary teams and senior management; act as the
Biomarker representative on Project teams.
• Author biomarker strategy documents, biomarker specific portion of clinical protocols, and
regulatory documents.
• Use biomarkers to identify opportunities to study compounds in new
indications/combinations.
• Identify, establish and oversee external collaborations with key opinion leaders, academic
sites, and CROs to advance our understanding of disease pathways and prognostic/predictive
biomarkers.
Key Qualifications:
• PhD and/or post-doc training in the area of immunology, or other related medical science
field with a minimum of 15 years of relevant biotechnology or pharmaceutical industry
experience.
• Knowledge of biomarker discovery and development, assay development/validation, clinical
discovery of biomarkers, and MoA/translational research.
• Candidate must be detail-oriented with excellent record keeping and organizational skills.
• Must be a highly flexible, results oriented, independent self-starter who enjoys working in a
fast-paced and dynamic, team-oriented environment.
• Excellent collaboration, communication, and interpersonal skills are required to engage and
be productive within a high achieving team environment.
• Ability to integrate complex scientific ideas, generate testable hypotheses, and execute
broad understanding of drug discovery and development in both early and late stage
development.
• Familiarity with regulatory approval process.
• Basic understanding of technical aspects of companion diagnostics development
• Proven scientific/leadership expertise (working in teams, managing people/projects
commensurate with a senior level).
• Strong experimental background and experience in hypothesis-driven biological/translational
research with demonstrated ability to execute well-designed experiments.
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Nov 27th, 2020 09:33PM
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Nov 27th, 2020 09:33PM
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Annexon Biosciences
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nasdaq:annx
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www.annexonbio.com
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app.trinethire.com
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Nov 28th, 2020 12:00AM
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Associate Director/Director CMC
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Open
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180 Kimball Way, Suite 200, South San Francisco, CA, United States of America
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180 Kimball Way, Suite 200, South San Francisco
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CA
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USA
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This position reports into the Vice President of CMC & Supply Chain Logistics. The Associate Director or Director will oversee efforts to develop and manufacture drug substance and drug product and to track clinical drug inventory. Responsibilities:· Act as a supporting contact to oversee production activities at CMOs and provide technical support and troubleshooting.· Collaborate with other functions at Annexon to develop and implement specifications for drug substance and drug product specifications and if needed, collaborate with QA and other functions to manage out of specifications, deviations and investigations.· Collaborate with Clinical Operations to ensure that drug supplies are available on-time for support of clinical studies.· Author and/or review batch records, change controls, and other technical documents.· Oversee the development and validation of analytical methods according to ICH guidelines to ensure effective characterization and release of clinical batches.· Design and oversee formulation development and stability studies for drug substance and drug product for multiple compounds.· Collaborate with QA, Regulatory Affairs and other functions towards timely generation of regulatory documents.· Work with discovery project leaders to determine if a viable initial development pathway for initial development exists for molecules being considered as development candidates.Qualifications and Other Required Knowledge and Skills:· A BS/MS/PhD in Analytical Chemistry, Biochemistry, or Pharmaceutical Chemistry is required, with 10+ years of related industry experience in drug substance and/or drug product development, production and analysis.· An in-depth knowledge and drug development experience in biologics, preferably monoclonal antibodies,is strongly desired, from early to BLA stage development.· Familiarity with protein purification, protein analytical and characterization techniques.· Familiarity and working knowledge of GMP/ICH regulations required, with experience working in a GMP facility preferred.· Team oriented professional with excellent organizational, communication, leadership and problem-solving abilities.· Working knowledge of quality by design and risk management is strongly desired. Knowledge of ICH Q8/Q9 and Q10 is preferred.· Experience overseeing external CRO based resources for production of drug substance and drug product.· Demonstrated ability to successfully coordinate multiple work streams and development efforts in a timely and economically responsible manner in small, start-up biotech companies.· Experience and familiarity with successful operation in the biologics CMC regulatory environment for early to mid-stage development.
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Nov 27th, 2020 09:33PM
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Nov 27th, 2020 09:33PM
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Annexon Biosciences
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nasdaq:annx
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www.annexonbio.com
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app.trinethire.com
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Dec 10th, 2020 12:00AM
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Vice President, Clinical Development - Ophthalmology
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Open
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180 Kimball Way, Suite 200, South San Francisco, CA, United States of America
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180 Kimball Way, Suite 200, South San Francisco
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CA
|
USA
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|
Annexon Biosciences is a clinical-stage biopharmaceutical
company developing a pipeline of novel therapies for patients with classical
complement-mediated disorders of the body, eye and brain. The Company’s
pipeline is based on its platform technology addressing well-researched
classical complement-mediated autoimmune and neurodegenerative disease
processes, both of which are triggered by aberrant activation of C1q, the
initiating molecule of the classical complement pathway. The Company’s first
product candidate, ANX005, is a full-length monoclonal antibody formulated for
intravenous administration in autoimmune and neurodegenerative disorders. The
Company’s second product candidate, ANX007, is a monoclonal antibody
antigen-binding fragment (Fab) formulated for intravitreal administration for
the treatment of neurodegenerative ophthalmic disorders. Based on learnings
from its initial trials, Annexon is advancing its current programs while
evaluating additional orphan and large market indications. Annexon is deploying
a disciplined, biomarker-driven development strategy designed to establish that
each of its product candidates is engaging the specific target at a
well-tolerated therapeutic dose in the intended patient tissue.Reporting into the Chief Medical Officer, the Vice President,
Ophthalmology Development will be responsible for driving Annexon’s growth by
providing strategic and operational leadership both cross-functionally and to a
team that they will build from the ground up. This role will entail the
development, implementation, and oversight of a robust early development
process for Ophthalmology-focused scientific initiatives within the
company.The Vice President will be a core member of the clinical and medical
team and will contribute to devising the overall clinical strategy and ensure
all activities occur in compliance with the appropriate regulations. They will
provide support to translational medicine efforts within Ophthalmology, working
closely with research and preclinical development to define strategy and
transition compounds from research into development candidates, and ensure
their effective, timely de-risking while ensuring time- and cost-efficiency of
the clinical development plan and clinical trial design.Responsibilities·
Lead the design and execution of clinical trials for ophthalmology
focused diseases in collaboration with cross-functional partners·
Collaborate across all levels in the organization, including
effective cross-functional interactions with R&D, program leadership, etc.·
Formulate clinical development plans (CDP) that integrate
scientific rationale, clinical need, clinical measurement approaches,
statistical rigor, regulatory and payor requirements, and company strategy·
Develop and implement high quality clinical studies to support the
CDP including biomarker and translational studies·
Provide medical monitoring, safety assessment, and overall
oversight for all clinical trials within Ophthalmology·
Serve as a content expert in the review of abstracts,
publications, medical information letters, and other medical documents as
needed·
Provide medical input into regulatory document preparation·
Lead content development for advisory board meetings·
Contribute to company success through both internal and external
medical education and medical/scientific information exchange and support·
Build relationships with key external stakeholders including, but
not limited to healthcare professionals at key institutions, patient advocacy
groups, and regulators by providing disease state education and communicating
the clinical value of Annexon’s scientific platform·
Drive a high-performance culture by fostering innovation, personal
accountability, and commitment for resultsQualifications ·
Ophthalmologist MD with 15+ years’ experience,
including at least five years of previous biopharmaceutical industry experience·
Expertise and awareness of the landscape in early
stage development in the Ophthalmology space ·
Proven expertise in translational medicine and
biomarker development ·
Experience executing and analyzing
proof-of-concept studies to drive programs forward strongly preferred ·
Understanding of adverse events and safety
packages preferred ·
Ability to understand and effectively communicate
scientific and medical information to both internal and external networks, in
support of the scientific and business strategy ·
Demonstrated leadership skills and experience
building effective teams·
Excellent written and oral communication skills ·
Ability to anticipate and adapt to change ·
Strong interpersonal skills commensurate with the
need to work closely with partners, investigators, contractors, consultants,
and team members across functions ·
Ability to communicate well with health care
professionals; ability to establish strong relationships with peer groups,
professional organizations, and other outside parties
·
Ability to travel up to 20%
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Dec 9th, 2020 09:18PM
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Dec 9th, 2020 09:18PM
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Annexon Biosciences
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nasdaq:annx
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www.annexonbio.com
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app.trinethire.com
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Dec 10th, 2020 12:00AM
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Sr. Director/VP, Project Team Leader
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Open
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180 Kimball Way, Suite 200, South San Francisco, CA, United States of America
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180 Kimball Way, Suite 200, South San Francisco
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CA
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USA
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Company Overview:Annexon Biosciences is a clinical
stage biotechnology company focused on developing novel inhibitors that are
designed to block C1q and the entire classical complement pathway. We are
pioneers in targeting C1q, the initiating molecule of the classical complement
pathway. By stopping the start of this pathway, our C1q inhibitors are designed
to treat multiple complement-mediated autoimmune, neurological and ophthalmic
diseases of the body, brain and eye. Annexon is headquartered in South San
Francisco CA. Job Description: As the leader
of one of our therapeutic franchises, the Project Team Leader will provide strategic scientific, business and operational
leadership and direction of the R&D development and advancement of
Annexon’s portfolio. In addition to developing and driving a comprehensive
lifecycle portfolio strategy, the Project Team Leader shall be responsible for
leading a cross functional leadership team of both internal and external
resources in all aspects of development pre-IND stage through late stage
development, ensuring consistent high quality output from the team and
achievement of program goals and objectives as well as drive effective
execution of such strategies by leading the cross functional team’s engagement,
integration, coordination and communication across functional lines. Duties for this role also include managing
R&D partnerships, helping to build necessary infrastructure for the R&D
organization and working with the executive leadership to create an environment
that supports rapid and high quality decision making (both for the portfolio
and the organization) and to identify, evaluate and find solutions for key
issues facing the programs on an ongoing basis. The Project Team Leader will
report into the SVP, Portfolio Strategy & Operations. Key
Responsibilities:·
Partnering with internal and
external stakeholders to drive the development of a comprehensive strategic
plan through registration and pre-commercialization preparation, including
goals, budget and risk assessment.
Includes developing program vision, strategy, scope/focus, milestones,
risk assessment and management strategies, as well as project investment
requirements.·
Leading cross-functional
Project Team focused on the development of Annexon’s clinical candidates, from
pre-IND through late stage clinical development and NDA submission for multiple
indications. Project Team shall include
representation from Research, Development, CMC, Regulatory, Quality, Commercial
and Finance. ·
Providing effective leadership
and direction to the cross functional Project Team, including scientific and
operational oversight of activities, budgeting and planning.·
Utilizing his/her understanding
of disease biology, global drug development and portfolio management within the
field of Neuroscience and/or Autoimmune disorders to effectively lead the
Project Team. ·
Partnering with executive team
to develop operating framework within R&D, including with regard to the
Project Team to clarify and facilitate decision-making and escalation around
strategic direction, resource allocation, etc. ·
Partnering with functional
areas to identify and ensure adequate resources for timely completion of goals
and objectives. Ensuring team members
understand program objectives, specifications, deliverables, timelines, and
tasks.·
Driving the development and
implementation of lifecycle portfolio strategy and follow-on drug candidates
for multiple diseases.·
Managing and communicating
program progress on a continual basis, identifying both cross-program and
cross-functional issues, resource issues, timeline issues, and budget issues. ·
Works on significant and unique
issues where analysis of situations or data requires an evaluation of
intangibles·
Exercises independent judgment
in methods, techniques and evaluation of criteria for obtaining results·
Participates in corporate
development of methods, techniques and evaluation criteria for projects,
programs and people·
Ensures budgets and schedules
meet corporate requirements·
Creates formal networks
involving coordination among groups.
Regularly interacts with executives and/or major internal and external
customers·
Works on abstract problems
across functional areas of the business. ·
Identifies and evaluates
fundamental issues for major function areas through assessment of intangible
variables. In-depth knowledge of functional areas, business strategies and
company goals.·
Interacts internally and
externally with executive level management requiring negotiation of matters to
influence policymaking bodies both internally and externally.·
Anticipates potential
roadblocks and issues of conflict and maintains open lines of communication in
problem solving and resolving issues and conflict. Knowledge/Skills:· Leadership: Experience leading and motivating teams in a matrix
environment is required. Proven interpersonal skills with ability to influence,
resolve conflict and drive decisions among internal cross functional teams,
executive management, and external teams. · Strategic Agility: Ability to develop and execute complex
strategies.· Collaboration/Relationship Management/Influencing: Ability to effectively collaborate in and
across multiple functions, and with internal and external stakeholders of
various backgrounds and skill sets. Skilled in establishing a
collaborative and respectful environment. Demonstrated skills in persuading senior
leadership on strategy, initiative(s) implementation, and decision-making.
Influences and motivates others to achieve objectives.· Decision Making: Strong
decision-making skills taking multiple perspectives into account and analytical
skills are required; exercises sound business judgment that has broad
organizational impact. · Communication: Excellent
communication skills (both orally and written) is critical to the success of
the role.·
Business Excellence: good at
developing the processes necessary to get things done, knows how to organize people and activities and knows what to
measure and how to measure. Demonstrated ability to interpret data into
actionable items.· Negotiation: Proven negotiation
skills that effectively drive discussions and decisions to desired end-results
that have broad organizational impact. Qualifications·
The successful candidate should
have an advanced degree in life sciences or medicine (PhD or MD) and/or commensurate
experience. He/she will have at least 10
years of industry experience in drug development, including experience in early
phase non-clinical and clinical drug development, regulatory knowledge and
pre-commercial market preparation. ·
Prefer scientific or industry
experience within the autoimmune, neurology and/or ophthalmology field.·
Will have a proven track record
of being a results-oriented leader and will have 5+ yrs. leading, managing, and
developing program related teams; prefer direct Project Team Leader experience.
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Dec 9th, 2020 09:18PM
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Dec 9th, 2020 09:18PM
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Annexon Biosciences
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nasdaq:annx
|
www.annexonbio.com
|
app.trinethire.com
|
Dec 10th, 2020 12:00AM
|
Director, Financial Planning & Analysis
|
Open
|
|
|
180 Kimball Way, Suite 200, South San Francisco, CA, United States of America
|
180 Kimball Way, Suite 200, South San Francisco
|
CA
|
USA
|
|
|
Company Summary
Annexon Biosciences is a clinical-stage biopharmaceutical company
developing a pipeline of novel therapies for patients with classical
complement-mediated disorders of the body, eye and brain. The Company’s
pipeline is based on its platform technology addressing well-researched
classical complement-mediated autoimmune and neurodegenerative disease
processes, both of which are triggered by aberrant activation of C1q, the
initiating molecule of the classical complement pathway. The Company’s first
product candidate, ANX005, is a full-length monoclonal antibody formulated for
intravenous administration in autoimmune and neurodegenerative disorders. The
Company’s second product candidate, ANX007, is a monoclonal antibody
antigen-binding fragment (Fab) formulated for intravitreal administration for
the treatment of neurodegenerative ophthalmic disorders. Based on learnings
from its initial trials, Annexon is advancing its current programs while
evaluating additional orphan and large market indications. Annexon is deploying
a disciplined, biomarker-driven development strategy designed to establish that
each of its product candidates is engaging the specific target at a
well-tolerated therapeutic dose in the intended patient tissue.
Desired Candidate Profile
The FP&A Director is a high impact,
executive-facing role that will report directly to the VP, Controller, and support
Annexon’s critical pipeline milestones, as well as the company’s growth toward becoming
a multi-product commercial-stage biopharmaceutical company. The FP&A Director
will have a key role in supporting multiple functional areas and project teams
within the Annexon organization. The role will have the unique opportunity to build
and work on budgets for various stages within the clinical development process
across the Annexon portfolio. This role
will partner closely with leaders across clinical operations, manufacturing,
and project management to drive the annual budget process, regular forecasts as
well as the long- range plan. Success in
this role will require cultivating partnerships across teams, strong
communication, ability to influence, and strategic thinking skills to drive
value to the business.
Specific ResponsibilitiesPartner with stakeholders to coordinate and develop annual budget and periodic forecasts, including OPEX, capital spend and headcount.Work with project management organization to leverage external data to understand and challenge expense projections for short- and long-term financial models.Work closely with department heads to review complex clinical and manufacturing contracts for costs and payment terms during the contract negotiation.Collaborate with cross-functional leaders to create monthly reporting dashboard to track key financial and performance metrics. Perform budget versus actual analysis at the consolidated, project, and department levels to identify and understand variances, assess associated risks and opportunities, and communicate results to senior management.Perform assessment FP&A system requirements and near-term implementation to support needs of the organization.Support adhoc requests as needed. Provide financial assessments and guidance for strategic projects and business cases. Develop and deliver presentations to senior management with clear and concise objectives, analyses, and recommendations.Key Qualifications:Bachelor’s degree in finance or accounting required. CPA and/or MBA preferred. Minimum of 8-10 years of increasing responsibility in finance or accounting. Professional experience in a biotechnology, pharmaceutical, or medical device organization.Prefer experience in company with late stage development or commercial stage products. Ability to establish strong business relationships and interact cross-functionally at all levels.Must possess strong problem-solving skills. Ability to work effectively to identify issues, gather relevant data points and recommend solutions.Must be a strong communicator capable of explaining/presenting complex financial concepts and problems clearly and effectively to all constituents. Customer service oriented; able to understand business requirements while maintaining ownership for projects and results.Highly detail oriented with strong analytical skills; experienced in developing financial models, leading analysis, and explaining options and implications.Highly motivated self-starter capable of working under pressure and prioritizing workload to meet deadlines. Strong team player with ability to demonstrate executive presence.Process and systems improvement mindset for creating solutions to problems that work across boundaries beyond this role.
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Dec 9th, 2020 09:18PM
|
Dec 9th, 2020 09:18PM
|
Annexon Biosciences
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nasdaq:annx
|
www.annexonbio.com
|
app.trinethire.com
|
Dec 11th, 2020 12:00AM
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Associate Director/Director, Program & Portfolio Management
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Open
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180 Kimball Way, Suite 200, South San Francisco, CA, United States of America
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180 Kimball Way, Suite 200, South San Francisco
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CA
|
USA
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Associate Director/Director Program & Portfolio ManagementPosition OverviewThe Associate Director/Director Program & Portfolio Management is a proactive and effective problem solver who is intellectually curious and works exceedingly well with others. This role is responsible for managing and driving cross-functional activities required to advance a program from preclinical development through BLA submission. The winning skill set includes working effectively and efficiently with cross- functional groups including nonclinical, clinical, technical development, regulatory, manufacturing, commercial planning and finance. As a key member of the Core Team, the Associate Director/Director, Program & Portfolio Management will work closely with the GPL (Global Program Leader) to help establish and execute program strategy and activities, integrate cross-functional input, synthesize team recommendations, and ensure program advancement on time and on budget. Lastly, the Director, Program & Portfolio Management is expected to create and maintain consistent project documentation including project plans, timelines, trackers and communications. Specific Responsibilities· In partnership with GPL and Core Team, develops and maintains integrated product development and lifecycle plans.· Creates and maintains project timelines that are critical tools for tracking progress against goals; closely and transparently manages the critical path of the project.· Proactively identifies critical milestones, interdependencies, risks and resource constraints that could impact project timelines and collaborates with teams to develop appropriate solutions.· Co-facilitates Core Team Meetings with GPL.· Responsible for Core Team documentation including meeting agendas, minutes, action item and decision trackers.· Ensures that all team members are fully informed and knowledgeable of project activities and status; optimizes communication within and between teams, in and outside of meetings.· Partners with Core Team to proactively address acute issues that arise.· Ensures that consistent project management tools and practices are used across team.· Supports continuous improvement efforts in Project Management practices at Annexon; leads department initiatives.· Ensures compliance with corporate policies and procedures, as well as, US healthcare laws and regulations.Position Qualifications· Undergraduate degree in a scientific, medical or business discipline; postgraduate qualification (e.g., Ph.D., MBA, MS) or commensurate experience is a distinct advantage.· A minimum of 8 years of biopharmaceutical industry experience, with half in a Project Management function supporting highly matrixed drug development teams comprised of, but not limited to, functional area representatives from Research, CMC, Regulatory, Clinical, Marketing and Finance.· Solid understanding of activities critical to early and late stage drug development projects; commercial-stage a plus.· Proven ability to manage complex, cross-functional development projects with Go/No Go decisions.· Well-versed at scenario planning and capable of rapidly integrating new information into existing plans.· Excellent meeting planning and facilitation skills.· Highly proficient at both building and maintaining Gantt charts, tracking systems, spreadsheets and tools that support a systematic and scalable approach to managing projects.· Highly organized, excellent writing and oral communication skills, motivated and analytically rigorous.· Experienced at partnering with team members to determine planning assumptions that drive timelines and budgets.· Adept at skillfully managing complex and challenging situations.· Team-oriented, with excellent interpersonal skills (i.e. collaboration, conflict management and negotiation).
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Dec 10th, 2020 09:23PM
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Dec 10th, 2020 09:23PM
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Annexon Biosciences
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nasdaq:annx
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www.annexonbio.com
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app.trinethire.com
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Dec 11th, 2020 12:00AM
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Sr. Director/VP, Project Team Leader
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Open
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180 Kimball Way, Suite 200, South San Francisco, CA, United States of America
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180 Kimball Way, Suite 200, South San Francisco
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CA
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USA
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Company Overview:Annexon Biosciences is a clinical
stage biotechnology company focused on developing novel inhibitors that are
designed to block C1q and the entire classical complement pathway. We are
pioneers in targeting C1q, the initiating molecule of the classical complement
pathway. By stopping the start of this pathway, our C1q inhibitors are designed
to treat multiple complement-mediated autoimmune, neurological and ophthalmic
diseases of the body, brain and eye. Annexon is headquartered in South San
Francisco CA. Job Description: As the leader
of one of our therapeutic franchises, the Project Team Leader will provide strategic scientific, business and operational
leadership and direction of the R&D development and advancement of
Annexon’s portfolio. In addition to developing and driving a comprehensive
lifecycle portfolio strategy, the Project Team Leader shall be responsible for
leading a cross functional leadership team of both internal and external
resources in all aspects of development pre-IND stage through late stage
development, ensuring consistent high quality output from the team and
achievement of program goals and objectives as well as drive effective
execution of such strategies by leading the cross functional team’s engagement,
integration, coordination and communication across functional lines. Duties for this role also include managing
R&D partnerships, helping to build necessary infrastructure for the R&D
organization and working with the executive leadership to create an environment
that supports rapid and high quality decision making (both for the portfolio
and the organization) and to identify, evaluate and find solutions for key
issues facing the programs on an ongoing basis. The Project Team Leader will
report into the SVP, Portfolio Strategy & Operations. Key
Responsibilities:·
Partnering with internal and
external stakeholders to drive the development of a comprehensive strategic
plan through registration and pre-commercialization preparation, including
goals, budget and risk assessment.
Includes developing program vision, strategy, scope/focus, milestones,
risk assessment and management strategies, as well as project investment
requirements.·
Leading cross-functional
Project Team focused on the development of Annexon’s clinical candidates, from
pre-IND through late stage clinical development and NDA submission for multiple
indications. Project Team shall include
representation from Research, Development, CMC, Regulatory, Quality, Commercial
and Finance. ·
Providing effective leadership
and direction to the cross functional Project Team, including scientific and
operational oversight of activities, budgeting and planning.·
Utilizing his/her understanding
of disease biology, global drug development and portfolio management within the
field of Neuroscience and/or Autoimmune disorders to effectively lead the
Project Team. ·
Partnering with executive team
to develop operating framework within R&D, including with regard to the
Project Team to clarify and facilitate decision-making and escalation around
strategic direction, resource allocation, etc. ·
Partnering with functional
areas to identify and ensure adequate resources for timely completion of goals
and objectives. Ensuring team members
understand program objectives, specifications, deliverables, timelines, and
tasks.·
Driving the development and
implementation of lifecycle portfolio strategy and follow-on drug candidates
for multiple diseases.·
Managing and communicating
program progress on a continual basis, identifying both cross-program and
cross-functional issues, resource issues, timeline issues, and budget issues. ·
Works on significant and unique
issues where analysis of situations or data requires an evaluation of
intangibles·
Exercises independent judgment
in methods, techniques and evaluation of criteria for obtaining results·
Participates in corporate
development of methods, techniques and evaluation criteria for projects,
programs and people·
Ensures budgets and schedules
meet corporate requirements·
Creates formal networks
involving coordination among groups.
Regularly interacts with executives and/or major internal and external
customers·
Works on abstract problems
across functional areas of the business. ·
Identifies and evaluates
fundamental issues for major function areas through assessment of intangible
variables. In-depth knowledge of functional areas, business strategies and
company goals.·
Interacts internally and
externally with executive level management requiring negotiation of matters to
influence policymaking bodies both internally and externally.·
Anticipates potential
roadblocks and issues of conflict and maintains open lines of communication in
problem solving and resolving issues and conflict. Knowledge/Skills:· Leadership: Experience leading and motivating teams in a matrix
environment is required. Proven interpersonal skills with ability to influence,
resolve conflict and drive decisions among internal cross functional teams,
executive management, and external teams. · Strategic Agility: Ability to develop and execute complex
strategies.· Collaboration/Relationship Management/Influencing: Ability to effectively collaborate in and
across multiple functions, and with internal and external stakeholders of
various backgrounds and skill sets. Skilled in establishing a
collaborative and respectful environment. Demonstrated skills in persuading senior
leadership on strategy, initiative(s) implementation, and decision-making.
Influences and motivates others to achieve objectives.· Decision Making: Strong
decision-making skills taking multiple perspectives into account and analytical
skills are required; exercises sound business judgment that has broad
organizational impact. · Communication: Excellent
communication skills (both orally and written) is critical to the success of
the role.·
Business Excellence: good at
developing the processes necessary to get things done, knows how to organize people and activities and knows what to
measure and how to measure. Demonstrated ability to interpret data into
actionable items.· Negotiation: Proven negotiation
skills that effectively drive discussions and decisions to desired end-results
that have broad organizational impact. Qualifications·
The successful candidate should
have an advanced degree in life sciences or medicine (PhD or MD) and/or commensurate
experience. He/she will have at least 10
years of industry experience in drug development, including experience in early
phase non-clinical and clinical drug development, regulatory knowledge and
pre-commercial market preparation. ·
Prefer scientific or industry
experience within the autoimmune, neurology and/or ophthalmology field.·
Will have a proven track record
of being a results-oriented leader and will have 5+ yrs. leading, managing, and
developing program related teams; prefer direct Project Team Leader experience.
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Dec 10th, 2020 09:23PM
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Dec 10th, 2020 09:23PM
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Annexon Biosciences
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nasdaq:annx
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www.annexonbio.com
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app.trinethire.com
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Dec 11th, 2020 12:00AM
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Director, Financial Planning & Analysis
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Open
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180 Kimball Way, Suite 200, South San Francisco, CA, United States of America
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180 Kimball Way, Suite 200, South San Francisco
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CA
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USA
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Company Summary
Annexon Biosciences is a clinical-stage biopharmaceutical company
developing a pipeline of novel therapies for patients with classical
complement-mediated disorders of the body, eye and brain. The Company’s
pipeline is based on its platform technology addressing well-researched
classical complement-mediated autoimmune and neurodegenerative disease
processes, both of which are triggered by aberrant activation of C1q, the
initiating molecule of the classical complement pathway. The Company’s first
product candidate, ANX005, is a full-length monoclonal antibody formulated for
intravenous administration in autoimmune and neurodegenerative disorders. The
Company’s second product candidate, ANX007, is a monoclonal antibody
antigen-binding fragment (Fab) formulated for intravitreal administration for
the treatment of neurodegenerative ophthalmic disorders. Based on learnings
from its initial trials, Annexon is advancing its current programs while
evaluating additional orphan and large market indications. Annexon is deploying
a disciplined, biomarker-driven development strategy designed to establish that
each of its product candidates is engaging the specific target at a
well-tolerated therapeutic dose in the intended patient tissue.
Desired Candidate Profile
The FP&A Director is a high impact,
executive-facing role that will report directly to the VP, Controller, and support
Annexon’s critical pipeline milestones, as well as the company’s growth toward becoming
a multi-product commercial-stage biopharmaceutical company. The FP&A Director
will have a key role in supporting multiple functional areas and project teams
within the Annexon organization. The role will have the unique opportunity to build
and work on budgets for various stages within the clinical development process
across the Annexon portfolio. This role
will partner closely with leaders across clinical operations, manufacturing,
and project management to drive the annual budget process, regular forecasts as
well as the long- range plan. Success in
this role will require cultivating partnerships across teams, strong
communication, ability to influence, and strategic thinking skills to drive
value to the business.
Specific ResponsibilitiesPartner with stakeholders to coordinate and develop annual budget and periodic forecasts, including OPEX, capital spend and headcount.Work with project management organization to leverage external data to understand and challenge expense projections for short- and long-term financial models.Work closely with department heads to review complex clinical and manufacturing contracts for costs and payment terms during the contract negotiation.Collaborate with cross-functional leaders to create monthly reporting dashboard to track key financial and performance metrics. Perform budget versus actual analysis at the consolidated, project, and department levels to identify and understand variances, assess associated risks and opportunities, and communicate results to senior management.Perform assessment FP&A system requirements and near-term implementation to support needs of the organization.Support adhoc requests as needed. Provide financial assessments and guidance for strategic projects and business cases. Develop and deliver presentations to senior management with clear and concise objectives, analyses, and recommendations.Key Qualifications:Bachelor’s degree in finance or accounting required. CPA and/or MBA preferred. Minimum of 8-10 years of increasing responsibility in finance or accounting. Professional experience in a biotechnology, pharmaceutical, or medical device organization.Prefer experience in company with late stage development or commercial stage products. Ability to establish strong business relationships and interact cross-functionally at all levels.Must possess strong problem-solving skills. Ability to work effectively to identify issues, gather relevant data points and recommend solutions.Must be a strong communicator capable of explaining/presenting complex financial concepts and problems clearly and effectively to all constituents. Customer service oriented; able to understand business requirements while maintaining ownership for projects and results.Highly detail oriented with strong analytical skills; experienced in developing financial models, leading analysis, and explaining options and implications.Highly motivated self-starter capable of working under pressure and prioritizing workload to meet deadlines. Strong team player with ability to demonstrate executive presence.Process and systems improvement mindset for creating solutions to problems that work across boundaries beyond this role.
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Dec 10th, 2020 09:23PM
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Dec 10th, 2020 09:23PM
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Annexon Biosciences
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