Director, Clinical Research

Alnylam Pharmaceuticals • Cambridge, KS

292d

About The Position

Alnylam Pharmaceuticals is seeking an imaginative physician drug developer, with the flexibility and confidence to work in therapeutic areas that may be beyond their particular 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 one of the clinical leads in a clinical development program in ATTR amyloidosis. 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 molecules 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 Regulatory, Biostatistics, Clinical Operations, Preclinical, 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.

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 or neurology is desirable.
• 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.

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.

What This Job Offers

• Career Level: Director
• Industry: Chemical Manufacturing
• Education Level: No Education Listed