Medical Development Director, Neuroscience

Location
Cambridge, MA, United States
Posted
May 30, 2021
Ref
R-07641
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Title:
Medical Development Director, Neuroscience

Company:
Ipsen Bioscience, Inc.

Job Description:

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

As Medical Development Director (MDD), you will be part of the Global Neuroscience Therapeutic Area team, participating in the evaluation and the development of the Clinical Development Plan (CDP) and medical aspects of the Integrated Development commercialization Plan (IDCP) of Ipsen's new products in neuroscience as directed by the Senior Vice-President (SVP) Neuroscience Therapeutic Area. You will work in partnership with Global Project Teams and in accordance with Target Product Profiles (TPP) as jointly developed with the Franchise.

Your role will involve:
  • Supporting all medical, scientific, strategic and clinical matters both Project Teams and drug development programs from lead compound identification to product registration and launch
  • Serving as the clinical referent for due diligence activities
  • Participating with TA Head and other senior managers in establishing strategic plans and objectives for new Neuroscience assets
  • Providing medical, scientific and strategic expertise, contribute to and/or prepare CDP and clinical trial related documents, including but not limited to Investigator Brochure, communication with regulatory authorities, clinical trial synopses, clinical trial protocols, clinical summaries, Clinical Study Report, with the support of other R&D functions and in line with IDP
  • Contributing to medical monitoring to ensure data integrity and coherence of data interpretation under the guidance of Target Patient Profile (TP) and IDP
  • Contributing to and reviewing scientific communication (abstracts, articles, presentations for internal and external purposes) of Ipsen sponsored studies
  • Establishing and maintaining professional relationships with external medical experts and key thought leaders and to represent Ipsen R&D Neuroscience TA at investigator meetings, advisory boards, scientific conference or alike
  • Proactively liaising with Global Drug Discovery to ensure scientific and medical integrity of IDP, TPP etc.
  • As appropriate, participating in competitive intelligence and/or other market/industry assessment activities and projects within the Neuroscience area.
  • Liaising with key internal experts as required to support pre-clinical programs and Project Teams for most efficient development of new chemical entities
  • Liaising with Early Clinical Development platform and Clinical Pharmacology department to provide medical expertise to Early Development programs (up to and including proof-of-concept studies)
  • Liaising as medical expert with External Innovation and business development teams to optimize the due diligence activities


In return, you will bring:
  • Medical Doctor (MD) preferred
  • Minimum 3 years' proven experience in Clinical Development or Neuroscience development area (from pre-clinical to registration) preferred
  • Substantial scientific and academic experience (preferably with clinical trial experience); with state-of-the-art medical, scientific knowledge; and track record of successful publications
  • Substantial experience in pharmaceutical drug development and, in industry context, track record of global clinical trials management
  • Previous experience directly and independently leading projects and/or a team of professionals
  • Previous experience on transversal projects (with other functions) and multiple therapeutic areas and stages of drug development, exhibiting the ability to influence others (above and beyond ones' own


If this sounds like an exciting opportunity to apply your clinical development experience in our Neuroscience 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.