Global Medical Affairs Director- Rare Diseases

Recruiter
Ipsen Biopharmaceuticals, Inc.
Location
Cambridge, Massachusetts
Posted
Sep 11, 2019
Closes
Sep 23, 2019
Ref
9b096b83a2a0
Organization Type
Corporate
Position Summary

A strong and collaborative partner driving medical strategy of the palovarotene Launch and Brand Plan in Fibrodysplasia Ossificans Progressive (FOP). The GMA Director will ensure the execution of medical affairs programs, provide medical expertise, training and support to the cross-functional team and work closely with the FOP community.

Essential Functions

Lead the development of the GMA Palovarotene Medical Plan as part of the Integrated Launch/Brand Plan and drive its execution
  • Ensure that key insights / analyses, opportunities and challenges, strategic priorities are developed as part of a cross-functional team approach to maximize alignment
  • Encourage opportunities for relevant countries to input at the initiation of the GMA Plan development process
  • Develop clearly defined medical objectives reflected in the prioritized medical activities
  • Ensure all medical activities have evaluation metrics directly related to the strategic priorities and medical objectives
  • Ensure that every new project starts with patients in mind, and its success is measured from their perspective.
  • Ensure all medical activities are budgeted
  • Ensure all medical activities are conducted in compliance with all applicable laws, regulations, codes, Ipsen Code of Conduct, Ipsen Ethical Principles and Ipsen procedural documents.


Drive palovarotene early access (EA) program and post-approval studies
  • Contribute to the EA Strategy and Drive its execution, in collaboration with clinical operations, country medical directors and the cross-functional teams
  • Contribute to the design and implementation of post-approval studies in collaboration with global drug development, clinical operations, country medical directors and the cross-functional teams
  • Define clear guidelines for local medical functions to design local company sponsored studies (CSS) and assess investigator sponsored studies (ISS)
  • Ensure GCPs, Ethics and medical compliance are applied within all programs, set-up and coordinate appropriate monitoring processes, in coordination with regions


Oversee the Medical Information, Education and Publication Activities in close collaboration with GMA Services, HEOR, Global Drug Development and other relevant functions
  • In collaboration with global publications manager, guide the publications strategy and ensure timely publication of non-clinical data and clinical trial results.
  • In collaboration with the global Medical Information manager, guide the Medical Information strategy and ensure availability of updated standard response documents (SRDs), Q&A and training documents
  • Provide guidance and content for internal medical training activities when relevant.


Work with the patients for the patients and establish strong collaborations with Scientific societies and cooperative groups
  • Collaborate across the entire company and externally to identify unmet needs and deliver outcomes that genuinely improve patients' lives as defined by patients themselves.
  • In collaboration with Public Affairs and other functions, identify and establish meaningful partnerships with Patients Advocacy Groups to co-create solutions that effectively meet patient's needs.
  • Lead the identification and collaboration with key experts, centers, scientific societies and cooperative groups in the field of education and clinical research in FOP and Rare Bone Diseases.
  • Ensure all medical activities are conducted in compliance with all applicable laws, regulations, codes, Ipsen Code of Conduct, Ipsen Ethical Principles and Ipsen procedural documents.


Provide Medical guidance and expertise across the organization
  • Support the Franchise for the Launch and Brand Planning
  • Provide medical expertise to Market Research, Market Access and HEOR activities
  • Participate in training needs assessment and training plan, create and/or validate product training content: medical educational materials, disease / product training packs, FAQs.
  • Support the countries to ensure launch readiness and excellence in timely execution


Education

MD/PharmD (or equivalent)

Experience
  • Clinical and/or Pharmaceutical Industry experience in Rare Diseases is highly preferred.
  • A minimum of 3 years of Global Medical Affairs experience within the Pharmaceutical/ Biotech Industry.
  • Business Development experience is a plus


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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