Senior Medical Director

About the Department

Our East Coast Global Development Hub brings together the best minds in life science innovation with facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple innovative modalities and therapeutic areas. Our East Coast Global Development Hub merges biotech speed and agility with large pharmaceutical company quality, resources, and stability, uniting the best of both worlds to develop new medicines for patients. We recognize that improving human health starts here and that patients rely on us. We’re changing lives for a living. Are you ready to make a difference?

 

The Position

As Senior Medical Director for the novel modalities team, you will be part of building, leading and managing a team highly skilled medical doctors and guiding them in their daily work as well as securing their personal and professional development. You will manage relationships with internal and external key collaborators, including Novo Nordisk affiliates. Additionally, ensure the medical deliveries for key development and life cycle management projects within our siRNA portfolio.

 

You will report to the Vice President of Medical and Science and become a member of the area's management team and collaborate closely with the other managers in the area. You will take an active part in developing the area as well as a lead role in various improvement projects, including process optimization.

 

Relationships

Reports to: VP, Medical & Science.

 

Work with the VP Medical/Scientific Development, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams.

 

Will be interfacing with both internal and external stakeholders including KOLs and Principal Investigators.

 

Essential Functions

• Support the VP Medical/Scientific Development as the US/international clinical lead for DCR-PHXC program to both internally and externally facing stakeholders
• Responsible for setting direction, leading, motivating, and developing team members
• In conjunction with other relevant functional areas, help develop/ refine the strategic development plan for DCR-PHXC and other emerging novel therapeutics
• Provide clinical and scientific expertise to the design of studies, writing of protocols and other study and regulatory-related documents for DCR-PHXC, and other programs
• Participate in the analysis and interpretation of data, ensure integrity of trial data, and assist in reporting of study results including preparation of scientific summaries, abstracts and manuscripts
• Provide leadership in the execution of clinical trials
• Ensure compliance with SOPs, ICH, GCP and other national and international regulatory requirements
• Work with the VP Medical/Scientific Development, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams to deliver and drive the timely completion of all clinical activities related to DCR-PHXC and other emerging clinical-stage programs
• Serve as a leading member, or participant, at multiple internal review groups and utilize novel and creative methods to resolve clinical development problems
• Work with the larger Global Project Team to deliver excellent medical support for DCR-PHXC and other clinical-stage programs
• Interface with US/international regulatory authorities, as appropriate, in support of the development objectives for DCR-PHXC and assist Regulatory Strategy staff in the compilation of submissions and in the responses to inquiries
• Lend clinical expertise to the Statistical Analysis Plan development and data management, and work closely with statistical programming and data management on the project level<