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 will thrive in this role. Specific qualifications include: • 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 neurology is desirable • 3+ years industry experience or equivalent clinical academic research experience • Sound scientific and clinical judgment • Familiarity with concepts of clinical research and clinical trials, 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 critical thinking and problem solving while exhibiting superior judgment and a balanced, realistic understanding of issues • Outstanding leadership and collaboration skills working within a matrix environment • Thrives in highly entrepreneurial biotech environment and embraces Alnylam’s culture of science, passion and urgency. About Alnylam We are the leader in RNAi therapeutics – a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what’s possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excell