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Medical Development Director

Employer
Ipsen Biopharmaceuticals, Inc.
Location
Cambridge One Main
Start date
May 2, 2024

Job Details

Title:

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:

  • 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.

Medical Oversight:

  • 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.

Regulatory Interactions:

  • 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.

Clinical Development Strategy:

  • 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.

KOL Engagement and Scientific Communication:

  • 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

Team Leadership and Mentorship:

  • 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.

Additional Info

  • 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.

Must have experience and be willing to perform in-depth clinical data

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.

Company

Ipsen (Euronext: IPN; ADR: IPSEY) is a global, biopharmaceutical group focused on innovation and specialty care. The group develops and commercializes innovative medicines in three key therapeutic areas - Oncology, Neuroscience and Rare Diseases. At Ipsen, we focus our resources, investments and energy on discovering, developing and commercializing new therapeutic options to provide hope for patients whose lives are challenged by difficult-to-treat diseases. Ipsen's North American operations and headquarters are located in Cambridge, Massachusetts, where our fully integrated biopharmaceutical team across External Innovation and Partnering, Research & Development (R&D), Manufacturing and Commercial collaborate. Cambridge is home to Ipsen's third global hub, in addition to R&D centers in Paris-Saclay in France and Oxford in the United Kingdom. With additional offices in Basking Ridge, N.J. and Mississauga, Ontario, Ipsen employs approximately 600 people in North America. For more information on Ipsen in North America, please visit www.ipsenus.com or www.ipsen.ca.

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Company info
Website
Phone
617-679-8500
Location
1 Main Street
Unit 700
Cambridge
MA
02142
US

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