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Medical Director / Sr. Medical Director

Cambridge, MA 02138

Posted: 11/29/2023 Employment Type: Direct Hire/Perm Job Category: Clinical Development and Operations Job Number: 591235 Is job remote?: Yes Country: United States

Job Description

Target Pay Rate: 316-385k **salary will be commensurate with experience 

Job Description:

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.
Skills, Knowledge and Expertise:
  • 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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