Director, Clinical Research- Benign Hematology

Job description

Overview Alnylam Pharmaceuticals is seeking an imaginative physician drug developer, with the flexibility and confidence to work across diseases within the neurology and hematology therapeutic area. This role includes the opportunity to provide clinical leadership in developing RNAi therapeutics in Alnylam’s expanding portfolio, which spans from rare genetic to common diseases. The successful candidate’s primary role will be one of the clinical study leads working on the plasminogen program transitioning from Phase 2 to Phase 3. The Director will report directly into the program clinical development strategy lead who provides the clinical research oversight of the program. The Director is expected to play a leading and influencing role in the overall clinical development strategies and drive progress and operational excellence of his/her clinical trial(s). This work will also involve extensive consultation and collaboration with external experts. 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. The Director will be a key Alnylam Development spokesperson at external meetings, including regulatory interactions and scientific meetings. Key Responsibilities Be a subject matter expert for the relevant disease area(s) 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 towards global regulatory approvals Oversight of trial conduct and safety 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 Qualifications A highly driven, dynamic, engaged and accomplished physician-scientist with experience and insight wil…