Director Medical Affairs Strategy and Operations

Location
Cambridge, MA, United States
Posted
Sep 01, 2020
Ref
R-04450
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Title:
Director Medical Affairs Strategy and Operations

Company:
Ipsen Biopharmaceuticals Inc.

Job Description:

The Director is responsible for leading strategic initiatives in partnership with the Senior Vice President North American Medical and lead operational and research activities within US Medical Affairs, compound/therapeutic area leadership, study set up and execution, as well as all vendor management and sponsor oversight activities. Activities will include partnership across the matrix organization in key strategic initiatives including medical transformation, medical planning and drive execution and medical value reporting. The Director, Medical Affairs Operations is responsible for the oversight of Medical Affairs Sponsored Studies (MASS) and Investigator Sponsored Studies (ISS) programs conducted for Ipsen Biopharmaceuticals, Inc. with respect to planning, implementation, coordination, reporting, and overall resource definition. Candidate will serve in a leadership role within Medical Affairs managing direct reports, stakeholder management for cross functional teams, as well as partner/alliance management within clinical development. He/She will also be responsible for Medical grants, advisory boards and overall medical budget management.

This position will report to the Senior Vice President, North America Medical.

Responsibilities

Responsibilities will include, but are not limited to, the following:
  • Manage North American Medical Leadership Team meetings and ensure execution of deliverables
  • Partner with the matrix partners in driving and delivering key strategic projects in medical
  • North America Medical Affairs Clinical Operations:
    • Manage team with direct reports within Operations
    • Clinical Operations lead on cross functional project teams and alliance teams
    • Has overall oversight for MASS and ISS from an Operations perspective
    • The direct oversight of all outsourced providers, i.e. CROs, CRAs, central laboratories, Electronic Data Capture (EDC), etc. for MASS
    • Responsible for organizing and delivering relevant training to Medical Affairs Operations / CRO staff
    • Ensure, in conjunction with the Regulatory, Pharmacovigilance and Data Management Departments, that the necessary regulatory, safety and data evaluation requirements are met to allow the conduct of clinical related activities
    • Participate in the selection of CROs and other external vendors and take responsibility for ensuring that CROs/vendors deliver in accordance with the specification, quality standard and timeframe set; manage CRO/CRA relationship as required
    • Prioritize and schedule all matters related to the Medical Affairs Research program
    • Leadership of internal and external meetings (i.e. ISS Reviews, Investigator Meetings) related to the Medical Affairs research
    • Supervise the schedule of work for Medical Affairs Operations personnel and CROs
    • Develop metrics and provide regular updates for Medical Affairs research activities
    • Complies with all laws, regulations and policies that govern the conduct of Ipsen U.S. staff
  • North America Medical Operations:
    • Supervise grants and IME process
    • Manage and track the US medical Affairs budget
    • Supervise the execution of medical affairs advisory board and other activities
    • Develop and track metrics and milestones for North America Medical Affairs activities


Education
  • Bachelor's degree required, advanced degree preferred
  • Degree in Life Science preferred


Experience
  • 10+ years substantial relevant experience of pharmaceutical drug development including project management of company-sponsored and investigator-sponsored clinical studies (Pharma or CROs)
  • Experience in team management, mentoring, coaching, performance management , building high performance teams
  • Excellent knowledge of Good Clinical Practice (GCP)/ICH regulations
  • Excellent understanding of industry guidance and best practices for ISS.
  • Experience managing and developing relationships with research vendors
  • Experience compiling and managing clinical study and medical affairs budgets
  • Experience with developing, reporting, and tracking research and medical performance metrics and able to train/develop staff in these areas
  • Experience in managing operations in Phase IV, Registry, Expanded Access Programs and HEOR studies being managed or planned for or assigned to Medical Affairs


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.","datePosted":"2020-05-28T00:00:00.000Z