- Collaborate with cross-functional teams (including Clinical Operations, Biostatistics Regulatory Affairs, Patient Safety, and Pharmacology/Pharmacometrics) to design and implement clinical trials.
- Ensure that clinical trial protocols align with scientific and regulatory requirements.
- Oversee patient recruitment, data collection, and safety monitoring during trials.
- Provide medical expertise to study teams, investigators, and site staff.
- Review and interpret clinical trial data, including safety and efficacy endpoints.
- Make informed decisions based on medical insights to optimize trial outcomes.
- Engage with regulatory agencies (such as the FDA or EMA) during clinical development.
- Prepare and submit clinical trial applications, investigator brochures, and other regulatory documents.
- Address regulatory queries and ensure compliance with guidelines.
- Contribute to the overall clinical development strategy for the company's pipeline products.
- Identify opportunities for expansion into new indications or patient populations.
- Evaluate scientific literature and competitive landscape to inform strategic decisions.
- Build relationships with Key Opinion Leaders (KOLs) in relevant therapeutic areas.
- Present clinical trial results at scientific conferences and meetings.
- Collaborate with external experts to enhance product understanding
- Depending on the candidate's expertise level, the responsibilities may include leading a team of clinical professionals, including Clinical Scientists and Medical Monitors.
- Effectively fosters productive and collegial working relationships with internal and external stakeholders in a cross-functional, matrix environment.
- This is a hybrid/remote role for the candidate : 60% presence on site
- Position open in our 3 R&D Hubs : Cambridge (US),Paddington (UK) or Boulogne/Les Ulis (France )
- However, if the candidate is local to the area, the candidate will be expected to come into the office occasionally.
- Advanced degree, MD
- Must have experience leading all aspects of clinical trials
- Must have pharma, clinical trial /R&D experience (3-5 years)
- Rare disease experience, pediatric and or hepatology experience in clinical development preferred
- Solution- and results-oriented, with a sense of urgency.
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Medical Development Director - Cambridge, United States - BioSpace
Description
Job DetailsTitle:
Medical Development Director
Company:
Ipsen Bioscience, Inc.
Job Description:
Ipsen is seeking an experienced Medical Director, Clinical Development to join our team and embark on a unique journey of advancing our clinical development programs in rare cholestatic liver disease. In this position, you will be an integral part of the clinical development team, supporting the execution of early and late-stage clinical studies. The ideal candidate will have outstanding communication skills, attention to detail, and the ability to thrive independently in a highly innovative and fast-paced environment.
Provide medical expertise and leadership in designing and implementing clinical development strategies aligned with company objectives.
Job Responsibilities
Clinical Trial Strategy and Design:
IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
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