Director, Clinical Research-Cardiology

Alnylam Pharmaceuticals•Cambridge, MA

10d•$255,000 - $345,000

About The Position

Alnylam Pharmaceuticals is seeking an imaginative physician drug developer to provide clinical leadership in developing RNAi therapeutics in cardiology and/or cardiometabolic health. The successful candidate will report directly to the program medical lead and will play a leading role in clinical development strategies, driving progress and operational excellence for clinical trials. This role involves interaction with the research group to advise on clinical development feasibility and proof-of-concept study design, as well as extensive consultation with external experts. Opportunities may arise to lead early-phase clinical development programs. The Director, Clinical Research will work in a matrix organization across various teams to ensure integrated development strategies and will serve as a key spokesperson at external meetings, including regulatory and scientific interactions.

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
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

Board Certification (or equivalent) or specialist training in cardiology or metabolic disease 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