Sr. Medical Director, Early Clinical Research, Cardiovascular/Metabolism

Alnylam Pharmaceuticals•Cambridge, MA

84d•$259,300 - $350,800•Hybrid

About The Position

Alnylam Pharmaceuticals is seeking an imaginative physician drug developer in Clinical Research - Cardiovascular & Metabolism (CVM) therapeutic area, also with the flexibility and confidence to work in therapeutic areas that may be beyond their expertise or experience. This is an opportunity 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’s primary role will be the early clinical research lead for multiple early-stage programs in CVM therapeutic area. The Sr. Medical Director, Clinical Research is expected to play a leading and influencing role in the overall clinical development strategies for the programs and to drive progress and operational excellence for the associated clinical trials. In addition, this role will include significant 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. The Sr. Medical Director, Clinical Research will work in a matrix organization across Regulatory, Biostatistics, Clinical Operations, Preclinical, Commercial & QA teams to ensure fully harmonized and integrated development strategies. This role will be a key Alnylam Development spokesperson at external meetings, including regulatory interactions and scientific meetings. The role will report to the SVP, CVM Clinical Research TA head. This position is hybrid and will be primarily located at our Cambridge, MA headquarters.

Requirements

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

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.