Lead clinical development activities for assigned clinical program(s) within a matrix environment and provide subject matter expertise and direction to the development and operations of assigned clinical project(s).
Reporting Line: Chief Medical Officer
- Apply knowledge of clinical development and project management to guide the creation of an overall product development plan for assigned clinical asset/s
- Establish clear project plans and budget/s, and lead and manage the day to day clinical development activities and resources to efficiently achieve critical clinical development milestones
- Work with clinical investigators, external medical advisors and subject matter experts to evaluate clinical trial designs/development options and institute path forward to ensure achievement of program objectives
- Provide direct managerial oversight and execution of clinical trials
- Identify and effectively leverage internal and external capabilities needed to advance clinical milestone activities.
- Ensure proper oversight of medical monitoring activities for clinical trials and respond to investigator questions concerning clinical trial conduct
- Interpret clinical trial data, and work with the project team/s and investigators to develop scientific conclusions from clinical trial data
- Contribute to the writing review and editing of study-related documents including clinical trial protocols, clinical study reports, regulatory documents, presentations and manuscripts for assigned clinical programs
- As senior medical/clinical lead directly contribute to the NDA submission pathway and support filing activities as needed
- Serve as the senior medical lead on interactions with regulatory authorities
- Represent the Company at medical/scientific meetings and congresses pertaining to areas of direct responsibility
- Prepare and deliver program updates
- Establish collaborative and productive relationships with parent company, internal/external partners and relevant affiliates.
- Perform other duties as requested by the senior management
- M.D. with thorough understanding of the oncology arena
- 10 + years of industry experience in clinical drug or program development or equivalent academic experience in clinical trials, especially in phase 1, 2 and 3.
- Demonstrated skills working within a matrix environment
- Ability to work collaboratively with others within and external to the company
- Expert level expertise in the design and conduct of clinical trials and project management in relevant therapeutic areas
- Experience evaluating outcomes of clinical trials and basic knowledge of clinical trial outcome standards
- Ability to evaluate complex clinical development options and propose solutions
- Ability to apply productive program management expertise to drive milestone achievement
Job Location: Cambridge, MA
Please send resumes to email@example.com