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Medical Director
3 months ago
**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**
In this role, Medical Director helps develop multiple products in different therapeutic areas and treatment modalities. In doing so, the 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. The Medical Director will also assist the Sr. Medical Director in the development and execution of strategic priorities within a therapeutic area, help develop PRO and biomarker strategies.
**Relationships**
Reports to: Vice President, 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 M&S team as the clinical lead for assigned programs to both internally and externally facing stakeholders
- Provide clinical and scientific expertise to the design of studies, writing of protocols and other study and regulatory-related documents
- 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, 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 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 clinical-stage programs
- Interface with US/international regulatory authorities, as appropriate, in support of the development objectives for the 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 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**
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.
Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.
**Qualifications**
- MD or the international equivalent is required
- Strong scientific background with experience in reviewing & interpreting scientific and study data is required
- Track record of scientific publications strongly preferred
- 1+ years Pharmaceutical/Biotech industry experience, including time managing clinical trials, or academic clinical research background
- Working knowledge of biostatistics, data management, clinical operations and scientific and technical processes desirable
- Working knowledge of the drug development process
- Team player who works collaboratively in a challenging team matrix environment
- Ability to work independently to resolve challenges and conflicts
- Excellent written and oral communication skills
- Integrity, honesty and highest ethical standards and a sense of perso
