Medical Director, Global Medical Affairs (CEMEA)

Medical Director, Global Medical Affairs (CEMEA)

Alnylam Pharmaceuticals

Amsterdam, Maidenhead or Munich

The TTR Medical Director, Medical Affairs, CEMEA reports to the Executive Medical Director, Medical Affairs, CEMEA and will be responsible for providing strategic, operational and scientific support for the TTR therapeutic program, including the marketed inline product (patisiran) and pipeline program (vutrisiran). The successful candidate will work with the medical sub-team to support the medical strategy for the TTR program, in alignment with the program strategy in CEMEA. This individual will be assigned strategic input of all CEMEA medical affairs activities to gain alignment across assigned geographic regions. The successful candidate will serve as the primary point of contact for specific regions and their respective country medical teams and liaising with counterparts in Clinical Development, Regulatory, Safety, Program Leadership, MAC (Global and Regional) and other relevant expertise areas within medical (e.g., VESt/Med Research, medical communications/publications, medical information, and patient advocacy).

Summary of Key Responsibilities

  • Provide strategic and scientific input and assigned regional oversight to the TTR therapeutic program within the medical sub-team framework to develop the regional medical strategies in alignment with TTR program strategy;
  • Represent medical affairs at TTR CEMEA and CEMEA MAC teams;
  • Work closely with country medical leads and their teams on assigned regional and their respective country medical planning and execution alignment with the overall global and regional program objectives for the TTR program (patisiran and vutrisiran);
  • Accountable for strategic and operational support of all medical affairs activities for CEMEA and partnering with VESt/Medical Research, Medical Services, and Medical Operations to track key milestones;
  • Collaborate with Clinical Development and Value and Evidence Strategy team to provide medical affairs input to pivotal study design; work closely with Preclinical, Regulatory, Clinical Operations, Biometrics, and Commercial to ensure strategic integration of product development and lifecycle plans;
  • Partner with Value and Evidence Strategy team and other stakeholders to define and prioritize TA-specific evidence gaps, develop and implement evidence generation strategy (e.g. Registry, phase 4 studies) to address stakeholder (HCPs, payers, and patients) needs;
  • Provide medical oversight of prospective and retrospective observational studies, comparative effectiveness research, chart reviews, registry trials, and other evidence generation projects;
  • Partner with Medical Services to ensure timely communication of scientific data (publication and medical congress);
  • Work closely with Regional Marketing to define key stakeholder engagement strategy and oversee engagement activities of regional KOLs;
  • Partner with Medical Services and Training to develop and deliver high quality scientific and skill-based training to medical team across regions;
  • Provide medical review for assigned regional commercial materials (CRB) and medical materials (MRB) for medical and scientific accuracy and consistency;
  • Work with country medical directors in assigned regions to identify Regional KOLs and develop engagement plans;
  • Support assigned regional and country efforts on patient identification and screening strategies and tactics;
  • Manage and support Regional Congress planning, execution, and attendance with country medical leads and MSLs (including abstract submissions, presentations, symposia, medical booth coverage, etc.);
  • Organize and lead Medical Advisory Board in order to gain further insights in key medical and scientific topics;
  • Organize regional Preceptorships and medical standalone meetings (Masterclasses), including agenda development, speaker identification and briefings.

Qualifications

The TTR Medical Director, Medical Affairs CEMEA will be part of a very visible and impactful medical affairs team within a dynamic, fast-paced, high-profile biotechnology company. The successful candidate will possess the following capabilities and characteristics:

  • MD preferred, PhD in life sciences, PharmD;
  • Demonstrated high-level professional knowledge and skills in the areas of medical affairs and R&D in the pharmaceutical or biotech industry;
  • Previous track record of leading medical programs or therapeutic areas in a matrix environment;
  • Demonstrate experience in working with rare or genetic diseases in a fast clinical and product development timeline highly preferred;
  • Knowledge of the biopharmaceutical industry and evidence generation with an understanding of key regulatory bodies;
  • High degree of professionalism, maturity, and confidentiality;
  • Strong written and verbal communication skills as well as strong leadership and interpersonal skills;
  • Demonstrated reputation as a well-respected, dynamic team player;
  • Capable of managing shifting priorities in a rapidly changing environment;
  • Ability to deliver on company program goals and objectives as they pertain to medical affairs;
  • Ability to affect positive organizational change at the company and team levels;
  • Travel will be required (approximately 30%).

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© EuroJobsites 2019

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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