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Medical Development Director, Rare Disease

Employer
Ipsen Biopharmaceuticals, Inc.
Location
Auburndale, MA, United States
Start date
Apr 16, 2021

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Discipline
Science/R&D, Pathology
Required Education
Other
Position Type
Full time
Hotbed
Genetown
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Job Details

Title:
Medical Development Director, Rare Disease

Company:
Clementia Pharmaceuticals USA, Inc.

Job Description:

Do you enjoy working in rare disease clinical development and advancing assets in the pipeline?

As Medical Development Director (MDD) you will be a member of the Global Rare Disease Therapeutic Area, reporting to the Global Asset Lead. You will provide medical guidance and leadership in the design, implementation, monitoring and interpretation of the FOP clinical trial and Phase 1 programs in support of IPN60130 clinical development programs.

Your role will involve:
  • Designing, implementing and monitoring clinical development studies towards regulatory approval
  • Providing medical input on required regulatory documentation and filings
  • Drafting clinical sections of regulatory filings, Phase I, II, and III clinical protocols, analysis plans and trial reports
  • Providing medical oversight on safety reporting for all clinical trials
  • Establishing and providing clinical and scientific leadership to investigators, advisory boards and consultants to guide clinical development
  • Representing Clementia/Ipsen at scientific and patient-centered meetings


In return, you will bring:
  • M.D. with specialty training in cardiology, pediatrics and/or bone and at least five years of pharmaceutical industry experience in clinical development with preference for rare disease drug development
  • Expertise and knowledge of the unique aspects of pediatric clinical drug development
  • Understanding of US and European regulatory requirements and processes for product testing and approval
  • Experience preparing for and presenting at US and European regulatory meetings such as Pre-IND, End-of-Phase 2, etc. preferred
  • In-depth knowledge of clinical protocol design, evaluation and conduct
  • Experience in the preparation and submissions of INDs, NDAs, and/or international registration dossiers
  • Demonstrated ability to design and execute clinical development studies for rare disease, preferably in pediatric populations and/or bone fields
  • Experience in analyzing, interpreting and reporting scientific results of clinical studies


If this sounds like an exciting opportunity to apply your clinical development experience in our Rare Disease Therapeutic Area, apply today!

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
United States
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