Medical Director / Sr. Medical Director
Cambridge, MA 02138 US
The Clinical Development team is responsible for all of the clinical trials we conduct for our product candidates. Currently we have four product candidates in phase I/II studies in oncology, most of them first in class compounds. Key Responsibilities:
- Providing clinical leadership and holding responsibility for all clinical deliverables within the assigned section of a clinical program and on a cross functional Project Team. Clinical deliverables may include development of protocols consistent with the Clinical Development Plans (CDP); clinical components of regulatory documents and brand related medical information, clinical communication and publications;
- Managing all operational aspects and driving execution of the section of the clinical program in partnership with other line functions.;
- Managing budget and resources in coordination with CMO, Head of Clinical development, Director of Operations and Project Managers, ensuring timely execution of assigned clinical deliverables within the approved budget;
- Participating in/contributing to activities with external stakeholders (e.g., regulatory authorities, key opinion leaders, advisory boards, patient advocacy groups), internal stake holders (e.g. Research, Translational Medicine, etc.) and internal decision boards;
- Supporting CMO/ Head of Clinical development in ensuring overall safety of the compound in collaboration with the Safety Leader for the assigned program section;
- Serving as the program spokesperson in internal and external meetings/boards;
- Leading development and ensuring implementation across program specific standards.
- Leading medical monitoring activities such as checking eligibility, characterize safety reports (causality), investigators training and engagement, helping with enrollment issues, protocol deviations, data review.
- 6+ years in clinical management of cancer patients and drug development and a minimum of 2+ years of drug development in large pharma or biotech.
- Demonstrated experience progressing therapeutic programs from IND-enabling studies into the clinic and in early and late phase clinical development, experience in biologics preferred. It is a plus experience in phase III trial.
- Familiarity with FDA and EMA regulations processes and guidances/guidelines; experience with global Regulatory (Health) Authorities is a plus
- Experience designing, running and analyzing clinical studies, preferably with biologics
- Experience with the principles of translational medicine, clinical pharmacology and early stage development
- Experience with clinical research concepts, practices, and GCP and ICH guidelines.
- Science and data-driven.
- Excellent leadership, interpersonal and communication skills, effective team player who can engender credibility and confidence within and outside the company; ability to prioritize and work in a fast-paced environment; ability and strong desire to “make things happen”.
**CO/NY candidates may not be considered
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