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Track Dicerna Pharmaceuticals hiring and firing trends, filtered by title, location, type, date, category and date of posting.
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nasdaq:drna dicerna.com dicerna.com Apr 25th, 2020 12:00AM Senior Medical Science Liaison - Northeast Open Medical Affairs Jan 28th, 2020 12:00AM <p><strong>Territory: </strong>New York, Massachusetts, Connecticut, Maine, New Hampshire, Vermont, Rhode Island</p> <p><strong>Job Description</strong></p> <p>Dicerna is a quickly growing biopharmaceutical company focused on the discovery and development of innovative, subcutaneously delivered RNAi-based therapeutics for the treatment of diseases involving the liver, including rare diseases, viral infectious diseases, chronic liver diseases and cardiovascular diseases.  The Company is leveraging its proprietary GalXC™ RNAi technology platform to build a broad pipeline in these therapeutic areas.   We believe our RNAi technology is and will be used to create a new category of medicines with the potential to improve the lives of patients with a variety of different diseases on a global level.</p> <p>The Senior Medical Science Liaison (Sr. MSL) is a scientific professional who serves as a key field-based scientific resource for healthcare providers, patients/patient organizations, industry partners (payors, advocacy groups, etc.) and internal colleagues.  The MSL also provides field-based scientific support for preclinical and clinical research.</p> <p><strong>Key Responsibilities</strong></p> <ol> <li>Possess superior knowledge of therapeutic area, including related disease states, co-morbid medical conditions, Dicerna products (including trial results), competitive developments, competitive products, and other therapeutic options within relevant disease states.</li> <li>Collect, analyze, and communicate fair-balanced information concerning therapeutic area, treatment options and emerging standards of care.</li> <li>Provide effective clinical and educational presentations (including regional roundtables) to internal and external audiences, and tailor presentations to meet specific needs of healthcare partners, KOL’s , patient organizations and academic institutions.</li> <li>Serve as a scientific expert at key medical and scientific conferences, advisory boards, clinical investigator meetings, internal meetings, and patient advocacy group meetings.</li> <li>Identify national, regional, and local Key Opinion Leaders (KOLs). Maintain and broaden professional relationships with KOLs to expand research, advisory, and educational partnership opportunities and assure thoughtful exchange of current medical information related to Dicerna products and therapeutic areas of clinical development with KOLs.</li> <li>Generate Field Medical Affairs plans to identify collaborative opportunities with KOL’s and institutions, review scientific program of relevant conferences, attend sessions, and provide a timely written conference report and summarizing of key information, activities, and competitive intelligence to colleagues.</li> <li>Assess feasibility, facilitate submission of requests, and serve as the primary liaison between Dicerna and investigator, for unsolicited Investigator- Sponsored Research (ISR’s ) after inception by the investigator and until publication of the data;</li> <li>Identify and communicate research gaps within therapeutic area;</li> <li>Assist with various medical affairs projects and initiatives, including support of medical information and publication initiatives</li> </ol> <p><span style="text-decoration: line-through;"><br> </span><strong>Qualifications</strong></p> <ol> <li>Advanced clinical or scientific degree (PharmD, PhD, or MD/DO) required.</li> <li>Minimum of 5 + years MSL or industry–related experience strongly preferred; Relevant therapeutic and clinical experience strongly desired, but not essential; Prior experience leading complex projects; Strong interpersonal skills; Excellent verbal and written communication skills.</li> <li>Experience in renal disease is strongly preferred; rare disease experience preferred.</li> <li>Flexibility to travel >50%.</li> </ol> Apr 25th, 2020 01:50AM Apr 25th, 2020 01:50AM Health Care Pharmaceuticals & Biotechnology
nasdaq:drna dicerna.com dicerna.com Apr 23rd, 2020 12:00AM Senior Director, Scientific and Real-World Evidence Open Medical Affairs Cambridge, Massachusetts, United States Cambridge MA USA Feb 18th, 2020 12:00AM <p>Reporting into Head, US Medical Affairs, Senior Director Scientific and Real-World Evidence is accountable for the development and execution of the scientific evidence and real-world generation plan that will demonstrate the clinical and economic value proposition of Dicerna’s investigational products (with focus on nedosiran-investigational product for primary hyperoxaluria).  This individual will support market access in generating evidence needed to obtain and maintain market access.   Critical to the success of this role will be the close collaboration with key functional areas within Dicerna, including: clinical development, market access, and patient advocacy to maximize value proposition of Dicerna’s therapies.</p> <p><strong>Key Responsibilities</strong></p> <ol> <li>Develop Evidence Generation Strategy/plan for Nedosiran, while maintaining in-depth knowledge of disease state, market, customer dynamics and reimbursement issues.</li> <li>Establish real world data plan, including data licenses and data platforms.</li> <li>Design research studies (including burden of illness, QoL, registry, natural history study) that generate evidence to support burden associated with disease state(s) of interest</li> <li>Coordinate with cross-functional partners (ie. Clinical development, regulatory, market access and clinical operations) to incorporate appropriate trial endpoints</li> <li>Provide input into planned clinical trials with Nedosiran and other investigational products in development by Dicerna</li> <li>Work closely with Market access to develop appropriate HEOR models, dossier, and other resources for submission to formulary committees/payors</li> <li>Provide input into life-cycle management opportunities, as well as prioritization of new therapeutic targets for development</li> <li>Collaborate with scientific communications team on publication planning and presentation of data (congresses)</li> </ol> <p> </p> <p><span style="text-decoration: line-through;"><br> </span><strong>Qualifications</strong></p> <ol> <li>Advanced clinical or scientific degree (PharmD, PhD, or MD/DO) required.</li> <li>Minimum of 10 years experience within pharmaceutical/biotech industry, with at least 7 years experience in HEOR or related function focused on generating evidence to demonstrate the clinical value proposition on an investigational product. Experience in rare diseases is preferred.</li> <li>In depth knowledge of US healthcare system; knowledge (and experience with) of global HTA processes and guidelines in preferred.</li> <li>Understanding of legal and regulatory issues impacting outcomes and PRO labeling/promotional claims</li> <li>Strong verbal and written communication as well as presentation skills</li> </ol> <p> </p> Apr 22nd, 2020 09:29PM Apr 22nd, 2020 09:29PM Health Care Pharmaceuticals & Biotechnology
nasdaq:drna dicerna.com dicerna.com Apr 23rd, 2020 12:00AM Manager - Chemistry, Manufacturing and Controls (CMC) Open Manufacturing Boulder, Colorado, United States Boulder CO USA Feb 25th, 2020 12:00AM <p>Dicerna Pharmaceuticals, Inc. is seeking a highly experienced and dynamic professional to support all chemistry, manufacturing and controls (CMC) regulatory and manufacturing requirements for Dicerna’s investigational products pipeline. This role will be responsible for providing strategic input and risk assessments throughout the product life-cycle. Additionally, this Manager will provide CMC guidance and support to internal groups such as quality, manufacturing, supply chain and regulatory affairs, as well as to outside groups, such as contract manufacturing organizations to ensure that products are manufactured in compliance with all applicable regulations. This position will require excellent technical, analytical and problem-solving skills, along with the ability to operate independently and to collaborate with cross-functional teams, contractors and external regulatory agencies. </p> <p><strong>Job Responsibilities will include:</strong></p> <ul> <li>Supporting the review of CMC content for accuracy, including data verification, clarity, consistency, and conformance to writing conventions, and present findings to management.</li> <li>Oversee functions within CMC, including but not limited to defining specifications, trending and analyzing batch data, maintain internal and external CMC documents, and supporting and defining aspects of distribution and release management.</li> <li>Work within CMC function to help generate manufacturing summary reports to inform product and process development and help identify and monitor product yields and/or quality.</li> <li>Develop and distribute periodic reports on performance, issues, risks, and schedules of key activities, events, or milestones.</li> <li>Serve as a CMC project contact with external and internal clients, as needed.</li> <li>Identify project issues and contribute to the development of alternative CMC Regulatory strategies.</li> </ul> <p><strong>Qualifications:</strong></p> <ul> <li>Degree in the Life Sciences or related field.</li> <li>Minimum of ten (10) years of relevant experience in pharmaceutical, biotechnology or a related industry focused on drug development.</li> <li>Demonstrated experience with oligonucleotide therapeutics and minimum two (2) years directly involved with CMC operation efforts.</li> <li>Excellent written and verbal communication skills.</li> <li>Excellent computer skills</li> <li>Excellent analytical skills and problem-solving skills</li> <li>Ability to manage competing priorities and timelines in a fast-paced, rapid-growth environment</li> <li>Ability to work collaboratively with cross-functional teams and contractors in order to drive results and meet company objectives</li> <li>Ability to function independently and exercise good judgment, as well as in a team-based environment</li> <li>Minimal travel required</li> </ul> <p> </p> Apr 22nd, 2020 09:29PM Apr 22nd, 2020 09:29PM Health Care Pharmaceuticals & Biotechnology
nasdaq:drna dicerna.com dicerna.com Apr 23rd, 2020 12:00AM Manager, Scientific Communications Open Medical Affairs Cambridge, Massachusetts, United States Cambridge MA USA Mar 11th, 2020 12:00AM <p>The Manager, Scientific Communications-Medical Affairs will assist with the analysis and creation of key, medical affairs deliverables, including creation of: abstracts/posters/manuscripts, resources for the field Medical Affairs team (slide decks and training materials), and creation of disease-state educational materials. This individual will work closely with clinical development colleagues regarding timing of data output from studies. This individual should be able to critically analyze data and then translate data into formats that meet the scientific needs of the external HCP community.  This individual will provide input into the review and approval of scientific materials in development within medical affairs and will assist with the scientific review of various R & D-related documents, including protocols and study reports for clinical trials.</p> <p><strong>Key Responsibilities</strong></p> <ul> <li>Oversee development of as well as plan, write, edit and format various scientific pieces and deliverables for the medical affairs team, including: slides decks, abstracts/posters/manuscripts and disease educational materials.</li> <li>Ensure highest degree of quality and medical accuracy for all pieces developed within medical affairs alongside achieving timely delivery.</li> <li>Review and approval of scientific materials developed, including “fact-checking” prn.</li> <li>Review of scientific documents, including protocols and study reports.</li> <li>Collaborate internally and externally as well as with the Global Team.</li> </ul> <p><span style="text-decoration: line-through;"><br> </span><strong>Qualifications</strong></p> <ul> <li>Advanced clinical or scientific degree (PharmD, PhD, NP/PA or MD/DO) required.</li> <li>Minimum of 8 years of experience in the pharmaceutical, biotech or related industry, with at least 5 years of experience in medical writing or publications.</li> <li>Experience in renal disease and/or is nice to have.</li> <li>Experience managing contract medical writers a plus.</li> <li>Proficiency in Microsoft Windows, Word, Excel, and PowerPoint required.</li> </ul> Apr 22nd, 2020 09:29PM Apr 22nd, 2020 09:29PM Health Care Pharmaceuticals & Biotechnology
nasdaq:drna dicerna.com dicerna.com Apr 23rd, 2020 12:00AM Product QA Sr. Associate/Specialist (Contractor) Open Quality Boulder, Colorado, United States Boulder CO USA Mar 16th, 2020 12:00AM <p>The Product QA Sr. Associate/Specialist (Contractor) resides at our Boulder, CO site and will report to the Sr. Manager of Product Quality Assurance. This individual is integral to the successful delivery of GMP Product Quality Assurance initiatives and related systems. This is an on-site, Monday-Friday assignment. Will be responsible for the review and approval of clinical and commercial pharmaceutical batch production records, while maintaining relationships with contract manufacturers to drive continuous improvement to their related quality systems and processes. This individual may also serve as a subject matter expert and trainer in batch record review. Other Quality related tasks may be assigned by Manager.</p> <p> </p> <p><strong>Responsibilities: </strong></p> <ul> <li>Receipt and internal tracking of executed batch documentation from contractors and the securing and archiving of these records within Dicerna systems</li> <li>Review and approve contractor’s manufacturing, packaging, and analytical records for GMP compliance and consistency with company policies and procedures necessary for Quality disposition of clinical and commercial intermediates, API and finished drug products at Dicerna</li> <li>Review contractor deviation investigations and initiate necessary records according to company procedures • Collect and maintain monthly product quality metrics data for QA Management</li> <li>Maintain databases and systems used for tracking various GMP manufacturing associated support activities</li> <li>Works closely with Regulatory, Supply Chain, Manufacturing and contractors to prioritize documentation review and product release</li> <li>Continually monitor quality systems and procedures for improvement opportunities while ensuring compliance to applicable regulatory requirements and standards</li> <li>Maintain documentation and records to ensure GMP Quality standards and compliance</li> <li>Support Regulatory Authority inspections and internal & external audits as needed </li> </ul> <p><br> <br><strong>Requirements:</strong></p> <ul> <li>Minimum 3 years direct experience in a GMP Quality Assurance role. Alternatively, 5-7 years related GMP industry experience or a BA/BS degree with Biology/Chemistry focus and minimum 2 years GMP industry experience</li> <li>Experience in a virtual, contract manufacturing based GMP environment for chemical or biologics based drug substances , drug products and final dosage forms preferred</li> <li>Experience with Veeva Vault or similar electronic document management system preferred</li> <li>Strong organizational skills, ability to multitask in a dynamic, fast paced environment</li> <li>Demonstrated analytical and logic skills with a focus on fact-based decision making and problem-solving</li> <li>Strong collaboration and written /verbal communications skills</li> </ul> Apr 22nd, 2020 09:29PM Apr 22nd, 2020 09:29PM Health Care Pharmaceuticals & Biotechnology
nasdaq:drna dicerna.com dicerna.com Apr 23rd, 2020 12:00AM Associate Director/Director, Clinical Contracts Management and Strategic Outsourcing Open Clinical Operations Cambridge, Massachusetts, United States Cambridge MA USA Mar 27th, 2020 12:00AM <p>The Associate Director/Director, Clinical Contracts Management and Strategic Outsourcing provides leadership with the contract and outsourcing function of Dicerna. Responsibilities include, conception and directions and strategic outsourcing initiatives, utilizing metrics to monitor risk and develop mitigations strategies in outsourced programs and assurance of an effective, cross-functional contract management process. This individual will recommend outsourcing strategies to best meet Dicerna goals and to ensure best value for our suppliers.  This individual will recommend value creation strategies for outsourced work.  This position will build cross-functional relationships and ensure sourcing processes are understood and followed with the functional teams at Dicerna. This position reports to the Vice President, Clinical Development and Operations.</p> <p><strong> </strong></p> <p><strong>Key Responsibilities</strong></p> <ul> <li>Draft, review, and negotiate various contracts (eg. Agreements, MSA’s, SOW’s, Change Orders) with clinical vendors, suppliers, institutions, collaborators, and partners</li> <li>Negotiate agreements, including detailed budgets and payment schedules, for all phases of clinical studies</li> <li>Create forms and template agreements, guidelines, and reference materials, as needed</li> <li>Monitor incoming contract requests and associated deadlines</li> <li>Update and maintain the clinical contract tracking database</li> <li>Manage contract expirations and reminders regarding upcoming deadlines</li> <li>Correspond with contracting parties, route for contract review, and obtain required signatures</li> <li>Build or update contracting and procurement processes</li> <li>Track and drive contracts to resolution, including identifying remaining contracting issues, identifying appropriate stakeholders to reach decisions, and scheduling meetings where needed</li> <li>Track negotiated terms across agreements and identify potential updates to contracting guidelines</li> <li>Proactively troubleshoot and implement short-term and long-term contract improvements and efficiencies</li> <li>Partner and consult with other departments resulting in proactive contract management with a keen awareness of corporate requirements while facilitating achievement of business goals and managing legal concerns, policies, and risks in accordance with applicable laws, rules and regulations</li> <li>Understand business needs and ensure contracts align with those needs</li> <li>Liaise with internal or external legal counsel, as needed</li> <li>Set value creation targets with the key partners and suppliers and develop key performance indicators; ensure timely reporting of key performance indicators (eg. operational metrics, savings, quality, customer service)</li> <li>Manage an efficient supplier or vendor selection process driving the team towards timely decisions with risks identified</li> <li>Train and mentor staff on department processes and contract knowledge</li> </ul> <p><strong> </strong></p> <p><strong>Qualifications</strong></p> <ul> <li>Bachelor’s degree is required. Advanced degree preferred</li> <li>At least 5 years contract management experience in a biotechnology, pharmaceutical, or CRO setting</li> <li>Experience drafting, reviewing, and negotiating clinical contracts and agreements</li> <li>Demonstrated expertise in clinical contracting and sourcing</li> <li>Broad and deep understanding of the standard contracts used in this industry (eg. master services agreements, confidential disclosure agreements, research collaborations, site agreements, manufacturing and clinical supply agreements, lab agreements, and CRO agreements)</li> <li>Familiar and comfortable with clinical operational practices, as well as FDA and international regulations</li> <li>Clinical trial experience is preferred</li> <li>Maintains contract alignment concerning financial, regulatory, compliance and disclosure requirements</li> <li>Ability to work collaboratively with all parties to negotiate contracts to completion</li> <li>Proven ability to interact, train, and build strong relationships with outsourced companies and clinical personnel</li> <li>Detail oriented, strong critical thinking and problem solving skills, excellent organizational and communication skills</li> <li>Occasional travel may be required</li> </ul> <p> </p> Apr 22nd, 2020 09:29PM Apr 22nd, 2020 09:29PM Health Care Pharmaceuticals & Biotechnology
nasdaq:drna dicerna.com dicerna.com Apr 23rd, 2020 12:00AM Human Resources Business Partner, Research & Development Open Human Resources Lexington, Massachusetts, United States Lexington MA USA Apr 16th, 2020 12:00AM <p><strong><em>Summary of Position: </em></strong></p> <p>As a senior member of the Human Resources team, the HR Business Partner will work closely with R&D leadership to enable innovation and the development of talent within our organization. We are driven by delivering meaningful outcomes for patients and creating an engaging and inclusive work environment for our people. The ideal candidate is committed to fostering a patient-centric culture, can partner effectively with various functional leaders and cross-functional teams while rolling up their sleeves to help the broader HR team, and has the ability to adapt and thrive in a fast-paced environment.</p> <p><strong><em>Position Responsibilities</em></strong><em>: </em></p> <ul> <li>STRATEGIC PARTNERSHIP: Lead human resources initiatives that drive results and accelerate innovation. Align strategic and tactical business plans into a practical and effective human resource agenda. Support and enable the Research & Development organization by providing expertise on all HR aspects of the business. Partner with senior leaders to develop and implement solutions to organizational and people-related challenges based upon HR expertise and in-depth understanding of the business. Provide leadership on matters of performance management, effective communication, organizational change and the creation of a winning culture. Develop and implement change management initiatives which facilitate/enable organizational growth and transformation and effect continuous improvement. Establish credibility throughout the organization and position self as an effective problem solver of people and organizational issues. Coach and develop leaders, supporting them while engaging in critical people activities and enabling them to make sound decisions.</li> </ul> <p> </p> <ul> <li>ORGANIZATION EFFECTIVENESS: Develop and implement organizational development/design strategies which align with business aspirations and drive optimal business results. Partner with management to remove barriers in order to drive operational transformation across all areas of the business. Lead the effort for continuous improvement of leadership capability and organizational efficiency.</li> </ul> <p> </p> <ul> <li>TALENT ACQUISITION: Partner with the R&D leadership team and Talent Acquisition Manager to develop proactive organizational staffing strategies to recruit and retain top caliber talent in a high-performance environment.</li> </ul> <p> </p> <ul> <li>EMPLOYEE RELATIONS: Act as senior advisor on all employee relations issues and effectively communicate to all levels of employees. Facilitate employee conflict resolution and the reduction of employee relations issues with a pragmatic approach grounded in business need and results. Handle sensitive matters with confidentiality and professionalism.</li> </ul> <p> </p> <ul> <li>PERFORMANCE MANAGEMENT: In conjunction with the Associate Director, HR and Associate Director, HRBP, develop, strengthen and implement appropriate programs to facilitate optimal performance of all R&D employees. Manage performance review process in pursuit of a culture of accountability and results-orientation, linking organizational and employee performance. Provide ongoing direct and actionable performance coaching and feedback to the organization’s leaders. Oversee annual performance review cycle and compensation planning for the R&D organization.</li> </ul> <p> </p> <ul> <li>EMPLOYEE COMMUNICATION: Encourage frequent and effective communication throughout the organization to ensure that employees are accurately informed. Foster a workplace environment consistent with the values and mission of the organization.</li> </ul> <p> </p> <ul> <li>CROSS-FUNCTIONAL INVOLVEMENT: Act as a mentor to fellow HR team members by providing guidance where appropriate. Provide back up to the Associate Director, Human Resources and Associate Director, HRBP as needed. Assist the SVP, HR by providing critical information and project oversight for ELT delegated projects/tasks.</li> </ul> <p><strong><em>Candidate Requirements:</em></strong></p> <ul> <li>Bachelor’s Degree.</li> <li>Minimum of 8 years of Human Resources experience; 2 years in a business partner capacity.</li> <li>Experience in a biotech or pharmaceutical organization, preferably supporting the R&D function.</li> <li>Elevated level of interpersonal skills to demonstrate active listening, provide coaching and advising to all levels within the organization and handle sensitive and confidential situations</li> <li>Strong business process aptitude and understanding; and highly developed analytical and reasoning skills.</li> <li>Deep knowledge of state and federal compliance and regulations.</li> <li>Computer proficiency with MS Office Suite.</li> <li>Must be able to work independently and part of a team, as well as handle multiple priorities in a fast-paced environment.</li> <li>Must be willing to perform on administrative tasks while functioning as a senior member of the HR team and the organization.</li> <li>Highly developed and excellent verbal, written and presentation communication skills.</li> </ul> <p><strong><em>Additional Information</em></strong></p> <ul> <li>Travel requirements (%): < 10%</li> </ul> Apr 22nd, 2020 09:29PM Apr 22nd, 2020 09:29PM Health Care Pharmaceuticals & Biotechnology
nasdaq:drna dicerna.com dicerna.com Aug 11th, 2020 12:00AM CMC Program Development Manager Open Manufacturing Boulder, Colorado, United States Boulder CO USA Aug 3rd, 2020 12:00AM <p>We are seeking a highly experienced and dynamic professional to manage drug development of the Dicerna programs as it relates to chemistry, manufacturing and controls. This individual will work closely with internal groups such as quality, manufacturing, supply chain, non-clinical and clinical and external stakeholders of the program to enable successful completion of program milestones.</p> <p><strong>Key Responsibilities</strong></p> <p>Provide planning, tracking, coordination, and cross-functional communication to enable teams to meet goals.</p> <p>Collaborate cross functionally with Dicerna internal teams such as Research, Regulatory, Nonclinical, Clinical, Manufacturing, Supply Chain and Quality.</p> <p>Communicate development plans and track progress at external contract manufacturers, contract labs, and Dicerna partners.</p> <p>Apply project management best practices in the development, initiation, tracking, planning, execution, control and closing of projects.</p> <p>Participate in development and sub-team meetings and assist as needed with agendas, project overviews, minutes, and action items.</p> <p>Perform administrative tasks including creation and maintenance of project plans, meeting scheduling and facilitation, agenda creation and tracking, and communicating detailed meeting minutes with key decisions/action items.</p> <p>Communicate and coordinate program activities as needed with internal and external stakeholders.</p> <p>Develop and distribute periodic reports on performance, issues, risks, and schedules of key activities, events, or milestones.</p> <p>Identify risks, brainstorm mitigation plans and facilitate resolution of issues adversely impacting the program.</p> <p> </p> <p><strong>Qualifications</strong></p> <p>BS degree in a science discipline. Advanced degree in the Life Sciences or related field preferred.</p> <p>Minimum of 10 years of relevant experience in pharmaceutical or biotechnology industry. Big Pharma experience preferred.</p> <p>Demonstrated experience in pharmaceutical drug development and minimum 3-5 years direct involvement with pharmaceutical project management.</p> <p>Excellent written and verbal communication skills. Expert skill level using MS Word, Excel, Project, and PowerPoint.</p> <p>Strong problem-solving and organizational skills.</p> <p>Adept at managing competing priorities and timelines in a fast-paced, rapid-growth environment.</p> <p>Ability to work collaboratively with cross-functional teams, contractors and external regulatory agencies to drive results and meet company objectives.</p> <p>Ability to function independently as well as in a team-based environment.</p> <p>Minimal travel required.</p> <p> </p> <p> </p> Aug 11th, 2020 06:54AM Aug 11th, 2020 06:54AM Health Care Pharmaceuticals & Biotechnology
nasdaq:drna dicerna.com dicerna.com Aug 11th, 2020 12:00AM Executive Director, Alliance Management Open Business Development Lexington, Massachusetts, United States Lexington MA USA Aug 3rd, 2020 12:00AM <p>We are seeking to fill the position of Executive Director, Alliance Management reporting to the Vice President, Business Development</p> <p> </p> <p> </p> <p><strong>Key Responsibilities</strong></p> <p><strong> </strong></p> <p><strong> </strong></p> <table> <tbody> <tr> <td width="699"> <p><strong>Job Purpose and Key Responsibilities: </strong></p> <p>·       Responsible for leading the company’s Alliance Management function across multiple partnerships with the leading pharmaceutical and biotech companies collaborating with Dicerna to develop a portfolio of innovative RNAi therapeutics. The collaboration pipeline includes assets and programs spanning from the discovery-stage through clinical development-stage including co-commercialization opportunities.</p> <p>·       Lead the Alliance Management group to deliver on the promise and spirit of the collaborations as well as build and foster strong relationships with key internal and external stakeholders, including with pharm/biotech and academic institutions.  </p> <p>·       Define and spearhead our Alliance Management strategy and process in collaboration with internal [and external] stakeholders.</p> <p>·       Provide direct input, guidance, and participation in alliance activities, including external and internal reporting.</p> <p>·       Ensure the delivery of value from all alliances in an efficient and timely manner.</p> <p>·       Build enduring relationships with industry AM leaders, ensuring Dicerna is well connected with the external alliance management community.</p> <p>·       Mentor and support Alliance Management team members, promoting a culture of trust, accountability, collaboration, open dialogue and employee empowerment. The jobholder should encourage and chart direct reports’ paths for professional development.</p> <p>·       As a key member of the Business Development team, this individual must be able to provide strategic and operational input to ensure the ongoing success of the business development strategy; including delivering the value of ongoing deals, highlighting new opportunities and actively encouraging people development for alliance management and the wider BD team.</p> </td> </tr> <tr> <td width="699"> <p><strong> </strong></p> <p>·      Maximize and optimize business opportunities from our existing collaborations by ensuring we and our partners:</p> <p>-        align on strategy, objectives, processes, and deliverables</p> <p>-        establish and maintain high quality communications and understanding</p> <p>-        proactively engage in identifying potential issues and strive to implement procedures to avoid or trouble-shoot such issues</p> <p> </p> <p>·       Establish and maintain an organizational culture of excellence in customer (partner) focus by ensuring that Alliance Management team members and internal stakeholders:</p> <p>-        provide a high degree of responsiveness to partners’ needs and timelines</p> <p>-        seek prompt and successful resolution to partners’ business needs</p> <p>-        encourage and maintain a sense of continuity in ever-changing operational landscape</p> <p>-        engender trust and understanding of partners’ concerns</p> <p> </p> <p>·      Identify standard procedures, approaches, processes, and techniques that augment our Alliance Management culture and organizational competence. Work with Alliance Management team members and other organization leaders to implement a plan to enhance Dicerna’s Alliance Management capabilities.</p> <p>·       Institute a strategy, in coordination with AM team members, to direct Alliance Management activities and interactions with multiple collaboration partners.</p> <p>·       Offer expert alliance management input on all new deals, ensuring implementation of best practices for governance structure and other operational activities.</p> <p>·       Ensure efficient and productive start to all new collaborations in close coordination with AM counterparts and cross-functional teams/stakeholders across both organizations.</p> <p>·       Optimize and continually enhance the post-deal relationship with collaborators to ensure success of the alliance, based on establishing a ‘meeting-of-the minds’ ethos for the successful progression and completion of all projects under the collaboration.  </p> <p>·       Build and enhance Dicerna’s reputation as the partner of choice in the RNAi field.</p> <p>·       Work closely with cross-functional teams and leaders to assure coordination of all issues and a single organizational point of view.</p> <p>·       Work with cross-functional leaders to develop the organizational view on priorities and strategies and effectively communicate them through alliance committee(s), and other key decision-making bodies (both internal and external).</p> <p>·       Assure effective relationship management is created and sustained through open communication and coordination within Dicerna and with our partners</p> <p>·       Assure Dicerna’s senior management is apprised in an effective and timely fashion of all alliance/issues and of recommended paths to resolution.</p> <p>·       Provide education and guidance to corporate team members on the nature, strategic rationale, legal requirements, and cultural sensitivities of each alliance.</p> <p>·       Be a mentor and a role model to direct reports [and colleagues] on all aspects of Alliance Management, with emphasis on competences and success factors specific to AM.</p> <p> </p> </td> </tr> </tbody> </table> <p><strong>Qualifications</strong></p> <table> <tbody> <tr> <td width="699"> <p> </p> <p>·       Technical and interpersonal skills required to develop and maintain relationships with internal and external stakeholders and team members.</p> <p>·       Ability to interact productively with senior leaders, management, and team members of alliance partners.</p> <p>·       Must have good understanding of the pharmaceutical discovery research, development and commercialization process.</p> <p>·       Must be able to operate independently and multi-task, dealing with information at a variety of levels on a large number of projects.</p> <p>·       Ensure ability to balance alliance management, scientific interests, and commercial needs.</p> <p>·       Possess good judgement in being able to make decisions knowing when it is appropriate to refer to more senior management.</p> <p>·       Resourceful in the ability to assimilate information from a wide range of sources e.g. scientific, technical, commercial, legal and financial.</p> <p>·      Earn and maintain a record of excellent interpersonal, influencing, negotiating and communication skills as well as high credibility with senior management.</p> <p><strong> </strong></p> </td> </tr> <tr> <td width="699"> <p><strong>Specialized Knowledge:</strong></p> <p>·       The jobholder should have at least 10+ years of experience in Alliance Management in the pharmaceutical/biotech industry.</p> <p>·       Expert knowledge in Alliance Management.</p> <p>·       Must have led and managed Alliance Management teams in established pharma/biotech/company(ies).</p> <p>·       Bachelor’s Degree, with Advanced degree or equivalent experience preferred.</p> <p>·       Knowledge of drug discovery, drug development and commercialization.</p> <p>·       Knowledge and experience with line and matrix management in a fast-growing and/or complex biotech or pharmaceutical company.</p> </td> </tr> </tbody> </table> <p> </p> Aug 11th, 2020 06:54AM Aug 11th, 2020 06:54AM Health Care Pharmaceuticals & Biotechnology
nasdaq:drna dicerna.com dicerna.com Aug 11th, 2020 12:00AM Vice President, Clinical Operations Open Clinical Operations Cambridge, Massachusetts, United States Cambridge MA USA Aug 3rd, 2020 12:00AM <p>This leadership position is accountable for resourcing, development, training and management of a highly performing clinical operations team. The position will provide strategic direction for, and executive oversight of, operational matters impacting Dicerna’s clinical development programs, including trial planning, study / protocol design and development, execution within budget and timelines, quality and compliance.</p> <p> </p> <p><strong>Key Responsibilities:</strong></p> <p>May include, but not limited to:</p> <p>Provide strategic and operational guidance to ensure that trials are properly defined, planned, and executed across all clinical stage programs</p> <p>Establish, implement, and proactively manage clinical trial processes, strategic outsourcing and performance indicators</p> <p>Ensure high standards for compliance with company SOPs, ICH-GCP guidelines, governing regulations and patient safety standards</p> <p>Lead and mentor the clinical project management, clinical documentation, clinical supply and clinical compliance functions, and other groups as needed, within the clinical operations department to ensure successful internal trainings are conducted, and project and organization goals are met; Serve as an advocate for professional development of Clinical Operations staff</p> <p>Provide continuous assessment and alignment of the clinical operations functions to ensure efficiency, effectiveness, and quality-by-design in operational execution; accountable for maintaining pro-active approach to inspection readiness</p> <p>Develop, negotiate, and manage the clinical operations budget</p> <p>Collaborate with legal, finance, and procurement to maintain continuity in planning, negotiation, forecasting and reporting metrics and milestones</p> <p>Oversee and trouble-shoot clinical development program challenges, processes, activities and risk mitigation strategies pertaining to the conduct of clinical trials and key milestone deliverables, with direct reports/functional leads</p> <p>Oversee and provide relationship management support for external vendors and clinical partners to ensure delivery of clinical objectives within established timelines and budget</p> <p>Senior contributor for business development activities providing clinical expertise and strategic operational considerations</p> <p>Clinical representative of executive teams including, the Quality Counsel, Executive Safety Committee, GxP Risk Management Team, applicable CRO/vendor governance and due diligence teams</p> <p>Clinical core team member for program-level management decisions</p> <p>Lead by example; provide advisory support to colleagues and foster collaborative decision-making and achievement of corporate goals</p> <p>Communicate regularly and effectively with senior leaders across the R&D organization</p> <p>Perform other duties as required and assigned by supervisor  </p> <p>Domestic and/or international travel as needed, ~30%</p> <p><strong>Qualifications:</strong></p> <p>Bachelors, Masters or Doctorate degree in a life-sciences discipline plus 15+ years progressive experience in clinical drug/device development, including 10+ years of Clinical Operations line management experience</p> <p>Domestic and international clinical trial execution experience required</p> <p>Post-approval clinical management experience a plus</p> <p>Direct management experience over clinically related functions and experience working in a matrix environment with other functional groups (eg. Regulatory, Medical Writing, Med Affairs, Commercial)</p> <p>In-depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.</p> <p>Experience in complex, rare and/or pediatric diseases, preferred</p> <p>Ability to manage early phase clinical programs up through to regulatory filing</p> <p>Demonstrated track record of successfully developing and executing on clinical development plans</p> <p>Proven ability to build strong relationships with external partners, CROs, and vendors including experience managing contracts and clinical finance activities</p> <p>Proficient at creating and communicating a clear vision among team members, effectively aligning resources and activities to achieve functional area and/or organization goals</p> <p>Analytical thinker with excellent problem-solving skills</p> <p>Excellent verbal and written communication skills</p> <p>Excellent planning, organization, and project management skills</p> <p>Flexibility to travel domestically and internationally, as required</p> <p>Proficiency with Excel and Microsoft Project</p> <p>English is the predominant language for most regulatory documents handled by this position; should be able to demonstrate good verbal and written English</p> <p><strong> </strong></p> <p> </p> <p> </p> Aug 11th, 2020 06:54AM Aug 11th, 2020 06:54AM Health Care Pharmaceuticals & Biotechnology

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