Director, Clinical Research
About The Position
Alnylam Pharmaceuticals is seeking an imaginative physician drug developer to provide clinical leadership in developing RNAi therapeutics. The successful candidate will be a clinical lead in a clinical development program in ATTR amyloidosis, reporting to the program medical lead. This role involves developing clinical strategies, driving trial progress, and collaborating with research, regulatory, biostatistics, clinical operations, preclinical, commercial, and quality assurance teams. The position also includes advising the research group on clinical development feasibility, designing proof-of-concept studies, and consulting with external experts. Opportunities to lead early-phase clinical development programs are anticipated. The Director will represent Alnylam externally at scientific and regulatory meetings.
Requirements
- MD with strong research background or MD PhD with best of class clinical and/or research training as shown through research support and peer-reviewed publications.
- Board Certification (or equivalent) or specialist training in cardiology.
- 3+ years industry experience or equivalent clinical academic experience.
- Sound scientific and clinical judgment.
- Familiarity with concepts of clinical research and clinical trial design, including biostatistics, and regulatory agency organization, guidelines, and practices.
- Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication.
- History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues.
- Outstanding leadership and collaboration skills working within a matrix environment.
- Experience and knowledge of working with biotech/pharma partner(s).
- Thrives in highly entrepreneurial biotech environment and embraces Alnylam’s culture of science, passion and urgency.
Nice To Haves
- Expertise in heart failure and/or amyloidosis is desirable.
Responsibilities
- Be the strategic leader providing a strong, clear voice for the clinical program.
- Develop creative but realistic approaches to drug development and lead clinical efforts to secure global regulatory approvals.
- Oversight of trial conduct and safety.
- Provide strategic consultation and guidance to Research on all decisions that have significant clinical components and implications.
- Collaborate closely with Preclinical, Regulatory Affairs and Medical Affairs to ensure tight strategic integration of product development plans.
- Be accountable via Clinical Research and Operations for all relevant timelines and deliverables.
- Supervise closely all major written deliverables (regulatory submissions, original articles, abstracts), and presentation materials.
- Be responsible for final review and sign off with respect to all controlled documents including protocols, investigator brochures, and informed consent forms.
- Influence internal and external audiences in a high impact, highly visible fashion.
Benefits
- medical, dental, and vision coverage
- life and disability insurance
- a lifestyle reimbursement program
- flexible spending and health savings accounts
- a 401(k)with a generous company match
- paid time off
- wellness days
- holidays
- two company-wide recharge breaks
- generous family resources and leave
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What This Job Offers
Job Type
Full-time
Career Level
Director
