Senior Medical Director, Early Clinical Research, Cardiovascular/Metabolism

About the role

The Sr. Medical Director, Clinical Research is expected to provide clinical leadership in developing RNAi therapeutics in Alnylam’s rapidly expanding CVM portfolio, which spans a number of disease areas including kidney disease. The successful candidate will serve as the early clinical research lead for multiple early-stage programs in CVM therapeutic area.

Responsibilities

• Be the strategic leader providing a strong, clear voice for clinical programs.
• Develop creative but realistic approaches to drug development and lead clinical efforts to secure first-in-human and proof-of-concept milestones.
• Oversight of trial conduct and safety.
• Serve as early clinical research lead on ePT (Early Project Team) or chair of CDST (Clinical Development Sub-Team) depending on the stages of programs, with accountability for the Clinical Development Plan.
• Provide strategic consultation and guidance to Research on all decisions that have significant clinical components and implications.
• Collaborate closely with Preclinical, Translational Research, Regulatory Affairs and Medical Affairs to ensure tight strategic integration of product development plans.
• Be accountable via Clinical Research and Clinical Operations for all relevant timelines and deliverables.
• Contribute to and/or closely supervise (as relevant) all major written deliverables (protocols, IBs, informed consent forms, briefing documents, regulatory submissions, original articles, abstracts) and presentation materials.
• Managerial responsibility with direct report(s) of Medical Director.
• 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.
• MD or MD PhD, Board Certification (or equivalent) or specialist training in Nephrology is preferred.
• 5+ years industry experience with early phase clinical program leadership experience in CVM or renal drug development, including leading trial design and execution and successful regulatory interactions.
• Ability to develop state-of-the-art CDPs and to navigate through internal governance boards in securing strategic approval of CDPs as well as resource planning and assignment.
• Experience in effectively leading x-EA global clinical team (or CDST equivalent), managing direct reports with strong mentorship, and exhibiting effective collaborations with other EAs to fulfill program goals and objectives.
• Strong medical monitoring skills.
• Sound scientific and clinical judgment.

Pay

$259,300.00 - $350,800.00