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Medical Director / Sr. Medical Director
Job Description
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.
- 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
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The 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, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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