Medical Director

Job Description

Summary / purpose of the positionThe Senior Medical Development Director (Sr MDD) is responsible and accountable for the development of the Clinical Development Plan (CDP) and medical aspects of the Integrated Development Plan (IDP) of Ipsens individual drugs (oncology) in partnership with Global Project Teams and in accordance with Target Product Profiles (TPP) as jointly developed with the Franchise. This position may also have a particular focus on leading the Global Project Team with overall accountability for a specific Drug Development program, designated as Global Development Lead (GDL). The Sr. MDD has oversight in managing a team of Medical Development Directors (MDDs) and Clinical Scientists.This position:
• Recognized as an influential leader, develops, proposes, and influences project and R&D teams on new uses for compounds currently in proof of concept and/or life cycle management. Provides solutions to senior managers in various areas, groups, and/or operations based on medical subject matter experience.
• Delivers high-quality medical/scientific/strategic input and medical/scientific interpretation on specific product data in fulfilment of the development business objectives for registration
• Ensures from a medical perspective compliance with GCP, ethical, scientific and medical guidelines and statutory principles throughout all clinical development activities
• Works closely in partnership with Global Regulatory Affairs, Global Drug Safety, Global Medical Affairs and Global Franchise Oncology in providing medical support for drug development programs
• Consistently works within complex medical situations under tight time constraints, prioritizing appropriately to deliver expected results.
• Manages effectively relationships in a cross functional and matrix environment with internal and external stakeholders
• Main responsibilities / job expectations Core Remit of Activities Internal to Therapeutic Area Development (approx. 65%)
  • Lead and manage the team, including recruitment, people development, talent management and performance management.
  • Support in all medical, scientific, strategic and clinical matters both Project Teams and drug development programs from lead compound identification to product registration and launch
  • Participate with Asset Lead, TA Head and other senior managers in establishing strategic plans and objectives
  • Provide 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
  • Assume ownership of CDP and medical aspects of IDP, and supervises CDP and IDP contributions of MDDs; ensure execution of CDP and establish where necessary cross-functional alignment to support execution of CDP
  • Share with Clinical Operations responsibility of clinical trials oversight and ensure the efficient, safe, ethical and high-quality conduct of clinical trials
  • Support the conduct of clinical trials as part of the Clinical Study Team and interfacing with CRO representatives
  • Contribute to and review scientific communication (abstracts, articles, presentations for internal and external purposes) of Ipsen sponsored studies

Keyskills :
translational scienceteam buildinginsight generationservice orientationstrategic thinkingtranslational medicinedecision-makingdrug development