Director, Clinical Research

Alnylam Pharmaceuticals • Cambridge, MA

2d

About The Position

Alnylam Pharmaceuticals is seeking a dedicated, dynamic, and creative physician drug developer, with the flexibility and confidence to work in therapeutic areas that may be beyond their subspecialty expertise or experience. This is an opportunity to provide clinical leadership in developing RNAi therapeutics in Alnylam’s rapidly expanding portfolio, which spans from rare genetic to common diseases. The successful candidate’s primary role will be as the clinical lead in a clinical development program in neuromuscular disease. He/she will report directly into the program medical lead who provides the clinical research oversight of the program. He/she is expected to play a leading and influencing role in the overall clinical development strategies for the molecule and drive progress and operational excellence for associated clinical trials. In addition, this role will include interaction with Alnylam’s research group, helping to advise the team on the clinical development feasibility of novel targets and the design of proof-of-concept studies. This work will also involve extensive consultation and collaboration with external experts. It is expected that additional opportunities will arise to lead bench-to-bedside early phase clinical development programs. The Director, Clinical Research, will work in a matrix organization across Preclinical, Clinical Operations, Biostatistics, Regulatory, Medical Affairs, Commercial & Quality Assurance teams to ensure fully harmonized and integrated development strategies. He/she will be a key Alnylam Development spokesperson at external meetings, including regulatory interactions and scientific meetings. Key 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. Oversee 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

Requirements

• MD with outstanding research background or MD PhD with outstanding clinical and/or research training as shown through research support and peer-reviewed publications.
• 3+ years industry experience or equivalent clinical academic experience
• Sound scientific and clinical judgment; history of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues
• 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
• Outstanding leadership and collaboration skills working within a matrix environment
• Experience with and knowledge of working with biotech/pharma partner(s)
• Thrives in highly entrepreneurial biotech environments and embraces Alnylam’s culture of science, passion and urgency

Nice To Haves

• Board Certification (or equivalent) or specialist training in neurology 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.
• Oversee 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

• comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match
• Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks.
• We also offer generous family resources and leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree
• Number of Employees: 1,001-5,000 employees