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nasdaq:drna
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dicerna.com
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dicerna.com
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Apr 23rd, 2020 12:00AM
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Senior Director, Scientific and Real-World Evidence
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Open
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Medical Affairs
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|
Cambridge, Massachusetts, United States
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Cambridge
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MA
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USA
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Feb 18th, 2020 12:00AM
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<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>
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Apr 22nd, 2020 09:29PM
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Apr 22nd, 2020 09:29PM
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Dicerna Pharmaceuticals
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Health Care
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Pharmaceuticals & Biotechnology
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|
nasdaq:drna
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dicerna.com
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dicerna.com
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Apr 23rd, 2020 12:00AM
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Manager - Chemistry, Manufacturing and Controls (CMC)
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Open
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Manufacturing
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|
Boulder, Colorado, United States
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Boulder
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CO
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USA
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Feb 25th, 2020 12:00AM
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|
<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>
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Apr 22nd, 2020 09:29PM
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Apr 22nd, 2020 09:29PM
|
Dicerna Pharmaceuticals
|
Health Care
|
Pharmaceuticals & Biotechnology
|
|
nasdaq:drna
|
dicerna.com
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dicerna.com
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Apr 23rd, 2020 12:00AM
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Manager, Scientific Communications
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Open
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Medical Affairs
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|
Cambridge, Massachusetts, United States
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Cambridge
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MA
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USA
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Mar 11th, 2020 12:00AM
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|
<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 &amp; 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>
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Apr 22nd, 2020 09:29PM
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Apr 22nd, 2020 09:29PM
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Dicerna Pharmaceuticals
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Health Care
|
Pharmaceuticals & Biotechnology
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|
nasdaq:drna
|
dicerna.com
|
dicerna.com
|
Apr 23rd, 2020 12:00AM
|
Product QA Sr. Associate/Specialist (Contractor)
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Open
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Quality
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|
Boulder, Colorado, United States
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Boulder
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CO
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USA
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Mar 16th, 2020 12:00AM
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|
<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 &amp; 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>
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|
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Apr 22nd, 2020 09:29PM
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Apr 22nd, 2020 09:29PM
|
Dicerna Pharmaceuticals
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Health Care
|
Pharmaceuticals & Biotechnology
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|
nasdaq:drna
|
dicerna.com
|
dicerna.com
|
Apr 23rd, 2020 12:00AM
|
Associate Director/Director, Clinical Contracts Management and Strategic Outsourcing
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Open
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Clinical Operations
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|
Cambridge, Massachusetts, United States
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Cambridge
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MA
|
USA
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Mar 27th, 2020 12:00AM
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|
<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>
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|
|
|
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Apr 22nd, 2020 09:29PM
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Apr 22nd, 2020 09:29PM
|
Dicerna Pharmaceuticals
|
Health Care
|
Pharmaceuticals & Biotechnology
|
|
nasdaq:drna
|
dicerna.com
|
dicerna.com
|
Apr 23rd, 2020 12:00AM
|
Human Resources Business Partner, Research & Development
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Open
|
Human Resources
|
|
Lexington, Massachusetts, United States
|
Lexington
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MA
|
USA
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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&amp;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 &amp; 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&amp;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&amp;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&amp;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&amp;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 (%): &lt; 10%</li>
</ul>
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|
|
|
|
Apr 22nd, 2020 09:29PM
|
Apr 22nd, 2020 09:29PM
|
Dicerna Pharmaceuticals
|
Health Care
|
Pharmaceuticals & Biotechnology
|
|
nasdaq:drna
|
dicerna.com
|
dicerna.com
|
May 7th, 2020 12:00AM
|
Nonclinical Writer
|
Open
|
Program Development
|
|
Boulder, Colorado, United States
|
Boulder
|
CO
|
USA
|
Apr 30th, 2020 12:00AM
|
|
<p><strong>Overview</strong></p>
<p>The nonclinical writer will be a key member of the Program Development Team and will work closely with colleagues in the nonclinical groups to manage all aspects of preparation for regulatory documents and scientific reports according to company guidelines and international governmental regulations. The individual will provide strategic direction to cross-functional teams to ensure that key messages are consistently aligned with reporting requirements and company objectives.</p>
<p> <strong>Responsibilities </strong></p>
<ul>
<li>Plan, author, edit, format, and finalize nonclinical regulatory documents; including, but not limited to: IND, CTA, summaries and updates to regulatory submissions, annual reports etc.</li>
<li>Work with nonclinical research colleagues to author scientific reports and invention disclosure summaries</li>
<li>Work with program development teams and the medical writing staff to assist in developing strategy for organizing and preparing documents for regulatory health authority submissions</li>
<li>Coordinate the internal review of nonclinical documents</li>
<li>Develop, maintain, and drive document finalization timelines</li>
<li>Ensure final documents adhere to internal standard operating procedures (SOP) and the International Council on Harmonisation (ICH)</li>
<li>Perform quality control (QC) review of documents</li>
<li>Assist in the development of templates, style guidelines, and SOPs for documentation</li>
<li>Potential to expand into nonclinical study monitoring</li>
</ul>
<p><strong>Requirements</strong></p>
<ul>
<li>Minimum requirement of a bachelor’s degree with 4+ years of nonclinical writing experience in a pharmaceutical/biotechnology or CRO environment</li>
<li>Ability to interpret and present nonclinical data objectively in a clear, concise format</li>
<li>Outstanding written and oral communication skills</li>
<li>Proficiency in teamwork, organization, and project management</li>
<li>Proficiency in MS Office</li>
<li>Experience with GLP study monitoring a plus</li>
</ul>
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|
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May 7th, 2020 01:36AM
|
May 7th, 2020 01:36AM
|
Dicerna Pharmaceuticals
|
Health Care
|
Pharmaceuticals & Biotechnology
|
|
nasdaq:drna
|
dicerna.com
|
dicerna.com
|
May 7th, 2020 12:00AM
|
Senior Manager, Clinical Supply Chain
|
Open
|
Clinical Operations
|
|
Cambridge, Massachusetts, United States
|
Cambridge
|
MA
|
USA
|
Apr 30th, 2020 12:00AM
|
|
<p>The Senior Manager, Clinical Supply Chain will be responsible for developing and managing the clinical supply plan for global clinical trials (all phases) at Dicerna Pharmaceuticals. This individual must have significant experience with clinical finished goods supply and production requirements, distribution activities, and labeling operations. This individual will work with external vendors and internal stakeholders to accomplish program objectives.</p>
<p>Key Responsibilities</p>
<ul>
<li>Ownership of clinical supply plan for global clinical trials (all phases)</li>
<li>Ownership of manufacturing/distribution relationship with external clinical suppliers</li>
<li>Supply management and setup/oversight of Interactive Response Technology (IRT)</li>
<li>Drive the label development internally and externally</li>
<li>Review and approval of documentation associated with clinical finished goods</li>
<li>Cross functional collaboration with internal team members, including but not limited to, quality, clinical operations, CMC, supply chain, and program management</li>
<li>Develop advanced planning tools in Excel (including distribution/manufacturing, expiry of IMP, timing)</li>
<li>Create monthly dashboard for clinical supply</li>
<li>Well versed in requirement for international shipping requirement for IMP (IoR, customs, providers of these services for clinical trials)</li>
</ul>
<p>Qualifications</p>
<ul>
<li style="font-weight: 400;">Bachelor's degree in the Life Sciences, Supply Chain Management, Industrial Engineering, or a related field is required. Advanced degree is preferred.</li>
<li style="font-weight: 400;">Minimum of 5 years of experience in clinical supply chain planning/distribution in a clinical research environment</li>
<li>Experience with supply planning and manufacturing/distribution operations for global clinical trials is required</li>
<li style="font-weight: 400;">Advanced MS Excel skills specific to planning global clinical trial supply</li>
<li style="font-weight: 400;">Proficiency in GMP/GCP processes, labeling, and import/export requirements for clinical supplies</li>
<li style="font-weight: 400;">Demonstrated ability to work independently and with cross-functional teams</li>
<li style="font-weight: 400;">Highly organized, detail focused with strong project management skills</li>
<li style="font-weight: 400;">Ability to multi-task and work in a fast paced and dynamic environment</li>
<li style="font-weight: 400;">Must be available for occasional travel</li>
</ul>
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|
|
|
|
May 7th, 2020 01:36AM
|
May 7th, 2020 01:36AM
|
Dicerna Pharmaceuticals
|
Health Care
|
Pharmaceuticals & Biotechnology
|
|
nasdaq:drna
|
dicerna.com
|
dicerna.com
|
May 7th, 2020 12:00AM
|
Senior Accountant
|
Open
|
Finance
|
|
Lexington, Massachusetts, United States
|
Lexington
|
MA
|
USA
|
Apr 30th, 2020 12:00AM
|
|
<p>Come help Dicerna scale! This is an exciting new role and opportunity to be a key member of the Finance and Accounting team supporting a dynamic and high growth organization. Dicerna is working to improve the lives of people suffering from rare diseases, chronic liver diseases, cardiovascular disease, and viral liver infectious diseases. We discover and develop innovative therapies to stop or turn off destructive disease processes by silencing the genes underlying these processes.</p>
<p>We are seeking a Senior Accountant who will support various aspects of financial cycle including, but not limited to fixed asset management, daily cash activities, monthly prepaids and accruals, intercompany accounting, and other quarter-end and year-end closing processes. The candidate will fit well in an environment that rewards bright, self-starting, energetic, team-oriented individuals with ever increasing responsibility and challenge.</p>
<p><strong>Key Responsibilities</strong></p>
<ul>
<li>Support the input and maintenance of financial workbooks for Cash, Fixed Assets, Prepaids and General Accruals. Prepare and post related journal entries</li>
<li>Support the Company’s close process including maintaining close binders, performing account reconciliations and monthly fluctuation analyses while ensuring policies and procedures are followed to comply with the requirements of Sarbanes Oxley</li>
<li>Support close process improvements in order to meet accelerated SEC filing timelines</li>
<li>Assist with the implementation of new ERP system</li>
<li>Support department goals, including implementations of accounting-related systems/applications and process improvements</li>
<li>Support the financial audits and the SOX 404 audits, including the preparation of PBCs (prepared by client schedules) for the audits and for our SEC filings</li>
<li>Perform other duties related to the accounting role as required</li>
</ul>
<p><strong> </strong></p>
<p><strong>Qualifications</strong></p>
<ul>
<li>Bachelor's degree in Accounting required</li>
<li>CPA preferred; Big 4 public accounting firm experience desired</li>
<li>2-5 years of combined public accounting and industry experience in a mid-size public company; preferred industry experience includes biotechnology, /pharmaceutical, medical devices, technology or software</li>
<li>Strong knowledge of US GAAP, internal controls and performing quarter-end close and reporting activities</li>
<li>Knowledge of intercompany accounting would be a plus</li>
<li>Strong Microsoft experience, with an emphasis on data analysis</li>
<li>Experience with financial systems such as SAP, Great Plains and ReQlogic</li>
<li>Outstanding communication (verbal and written) and organizational skills</li>
<li>Ability to effectively communicate across functional areas</li>
</ul>
<p> </p>
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|
|
|
|
May 7th, 2020 01:36AM
|
May 7th, 2020 01:36AM
|
Dicerna Pharmaceuticals
|
Health Care
|
Pharmaceuticals & Biotechnology
|
|
nasdaq:drna
|
dicerna.com
|
dicerna.com
|
May 7th, 2020 12:00AM
|
Executive Level, Head of Quality
|
Open
|
Quality
|
|
Cambridge, Massachusetts, United States
|
Cambridge
|
MA
|
USA
|
Apr 30th, 2020 12:00AM
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<p>The Executive Level Head of Quality is responsible for the development, realization, and execution of cost effective, risk-based, and compliant quality assurance and compliance programs and systems, in support of the company infrastructure, as well as our external collaborations in order to fully support Dicerna’s drug development and commercial manufacturing activities (domestic and international.) She/he will report to the Executive VP and Chief Operating Officer and will have a functional reporting relationship to the Chief Compliance Officer under the Corporate Compliance Plan. She/he will develop, lead and manage her/his department and activities, while seamlessly collaborating and leading cross-functional processes and systems with: Manufacturing, Supply Chain, R&amp;D and others, to enable overall success of stakeholders and partner organizations. The Executive Level Head of Quality will help form transparent and productive cross-functional relationships with the internal functions to assure alignment of goals and objectives for pre-clinical to commercial phase programs and products, ensuring cGMP, cGCP, and cGLP compliance and realization of other value-added guidelines and best practices. The Executive Level Head of Quality must be capable of formally/informally influencing and interacting with external suppliers and other stakeholders through collaborative, actionable and common goals and objectives enabling efficient, effective and compliant overall success and execution.<br> <br> <strong><u>Responsibilities</u></strong></p>
<ul>
<li style="font-weight: 400;">Leads, inspires, develops and manages a highly capable team of Quality professionals with a clear vision and pragmatic collaborative execution to install and realize the appropriate Quality processes, systems and relationships to drive world-class performance.</li>
<li style="font-weight: 400;">Enables the cross-functional success, growth and development of Global operations approaches, initiatives, processes, projects and most importantly, staff and peers.</li>
<li style="font-weight: 400;">Provides savvy, experienced, credible business leadership through the lens of a deep Quality mindset, focused on enabling successful business and organizational outcomes.</li>
<li style="font-weight: 400;">Sets, enables and models a culture of collaboration and alignment among critical functions to ensure strategic objectives are met across all aspects of our operations and quality programs, processes and projects.</li>
<li style="font-weight: 400;">Ensures the company is in a constant state of inspection readiness across all functions through continuous education, training and internal audits.</li>
<li style="font-weight: 400;">Collaborates with internal and external stakeholders and partners to enable and ensure appropriate implementation of the quality assurance requirements of Drug cGMPs, cGCPs, cGLPs and associated industry guidelines as appropriate.</li>
<li style="font-weight: 400;">Establishes QA strategic plans, with input from functional areas in support of R&amp;D and commercial product quality assurance requirements for new drug candidates and ensures that those plans are implemented.</li>
<li style="font-weight: 400;">Develops key quality processes, metrics and indicators to measure, trend manage and improve key quality attributes of our virtual supply network, as well as strategies and tactics to communicate progress and issue resolution to appropriate internal/external stakeholders.</li>
<li style="font-weight: 400;">Assures that the appropriate suite of Standard Operating Procedures (SOP’s) are in place and optimally maintained to support the critical drug development activities as well as our vendor relationships with our external CRO or CMOs.</li>
<li style="font-weight: 400;">Facilitates the appropriate authoring and implementing of QA SOPs as well as review of functional SOPs.</li>
<li style="font-weight: 400;">Coordinates and executes periodic Quality Management Reviews and trend analysis of all aspects of cGXP operations.</li>
<li style="font-weight: 400;">Ensures the review and audit of internal department processes for compliance with applicable cGCP, cGMP and/or cGLP regulations or guidance’s.</li>
<li style="font-weight: 400;">Ensures a robust and risk-based audit program is successfully realized throughout our vendor network.</li>
<li style="font-weight: 400;">Assures the planning and conduct of periodic compliance training on GLP, GMP and GCP regulations.</li>
<li style="font-weight: 400;">Manages and coordinates (with internal functions, partners, CROs and CMOs) the regulatory inspections for Dicerna as well as participation as appropriate in the company’s GXP regulatory inspections.</li>
<li style="font-weight: 400;">Acts as the company’s primary interface for communication with Regulatory agency field inspectors and ensures prompt and complete response to all regulatory inspection findings.</li>
<li style="font-weight: 400;">Negotiates, develops and realizes the appropriate development and management of value-added quality agreements with our CMOs, CROs, partners and suppliers.</li>
</ul>
<p><strong><u>Position Requirements</u></strong></p>
<ul>
<li style="font-weight: 400;">Advanced degree in a scientific or operational discipline relevant to the life sciences arena.</li>
<li style="font-weight: 400;">15+ years of quality assurance experience in a corporate drug development organization including several years’ experience in small molecule and/or peptide drug development and preferably, with oligonucleotide experience.</li>
<li style="font-weight: 400;">A minimum of five years of demonstrated experience in a Leadership role, managing a high performing-team across company locations.</li>
<li style="font-weight: 400;">Multidiscipline expertise and experience in a CMC QA role as well as familiarity with Clinical and Non-Clinical requirements and responsibilities.</li>
<li style="font-weight: 400;">Excellent working knowledge, understanding and experience with the practical implementation of FDA and EMA regulations and guidelines in cGXP environments (cGLP, cGCP and cGMP).</li>
<li style="font-weight: 400;">Highly capable and knowledgeable in the concepts, practices and leadership of process-based management and team governance.</li>
<li style="font-weight: 400;">Established leader in the pharmaceutical industry with clear and proven capability developing, communicating, leading, managing and inspiring within and beyond Quality and its efforts.</li>
<li style="font-weight: 400;">Exceptional oral and written communication skills to all employment levels, Executive Leadership Team, Board of Directors and external partners, suppliers and industry organizations.</li>
<li style="font-weight: 400;">Proficient in understanding and analyzing financial reports and overall business acumen.</li>
<li style="font-weight: 400;">Demonstrated ability to analyze, extrapolate data, hypothesize, plan, communicate and implement in a highly collaborative and engaged environment.</li>
<li style="font-weight: 400;">Exceptional interpersonal skills including the ability to influence behaviors and negotiate and resolve challenges with poise, tact and diplomacy.</li>
</ul>
<p><strong><u>Travel Requirements</u></strong></p>
<ul>
<li style="font-weight: 400;">&lt;20%; Projected amount of global travel to support team, audits etc.</li>
</ul>
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May 7th, 2020 01:36AM
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May 7th, 2020 01:36AM
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Dicerna Pharmaceuticals
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Health Care
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Pharmaceuticals & Biotechnology
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