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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 
 

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Cambridge, MA

Calling all job seekers! Discover exciting job opportunities in and around Cambridge, Massachusetts, a vibrant city known for its rich history, world-renowned universities like Harvard and MIT, and innovative tech scene. Cambridge offers a unique blend of academic excellence, cultural diversity, and a thriving arts community, with attractions like the iconic Harvard Square, the charming Charles River Esplanade, and the prestigious American Repertory Theater. From savoring local specialties like clam chowder and lobster rolls to cheering on the Red Sox at Fenway Park, there's something for everyone in this dynamic region. Explore job listings today and kick-start your career in this captivating area!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.