Senior Medical Director

About the Department

Our Boston Research & Development hub, anchored in the greater Boston area, brings together the best minds in life science innovation. The teams located in facilities in Lexington, Watertown and Cambridge reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. Our greater Boston R&D 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.

 

The Position

We are seeking an enthusiastic Senior Medical Doctor with a high degree of scientific acumen who is excited by cutting-edge biotechnology and wishes to take part in the unique opportunity to bring highly innovative pharmaceutical products through clinical development to market. The candidate is a team player, detail oriented with prior research experience, either in academia or industry.

 

In this role, the incumbent will help develop multiple products, including Novo Nordisk’s most advanced GalXC™ product candidate, DCR-PHXC, which is being created for the treatment of primary hyperoxaluria. In doing so, the Senior Medical Director will work across different functional teams to support the design and execution of clinical trials, the drafting of medical/ scientific documents, safety monitoring, and data analyses. In this high visibility position, the candidate will be interfacing with both internal and external stakeholders including KOLs and Principal Investigators.

 

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
• 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
• PArtner 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
• Act as a liaison between the company and clinical site investigators and KOLs
• Interface together with VP Medical/Scientific Development with Safety Review Committees and Data Safety Monitoring Committees
• Participate in safety review meetings and providing medical monitoring of ongoing clinical trials

 

Physical Requirements

10-20% overnight travel required.

 

Development of People

Supervisory, ensure that reporting personnel have Individual Development Plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process. Ensur