Director Medical Affairs

at  MSD

Job Description
The Country Medical Director Czech Republic reports into CEE/SEE/Baltic Cluster Medical Lead.

(S)he will be the primary country level contact for medical affairs. (S)he is responsible for

• Oversight of the development and execution of the Medical Affairs (MA) strategy for the country, based on understanding of global, regional and local opportunities and requirements;
• creating and maintaining a high performing, highly compliant MA organization for the country
• representing local opportunities, requirements and needs at the regional and/or global levels, as appropriate;
• representing company in external activities requiring the presence of the country’s (or cluster’s) Senior Medical Leader; and
• coordinating with the country or cluster GCTO, Pharmacovigilance, and (where applicable) CORE, BARDs to ensure well-functioning interactions between company and external in-country stakeholders
• managing the entire portfolio for our company, allocating resources balancing global and local priorities. (S)he builds on existing capabilities through internal development and external hiring, analyzes and fills gaps by reallocating resources and creates an empowering, compliant, collaborative, and innovation-focused work environment.
• managing the medical aspects of submissions for reimbursement or tenders for entire portfolio of medicines and vaccines (collaboration with CORE, market access, and commercial colleagues).

As part of the Leadership of GMA, the Country Medical Director will assist in maintaining GMA as a leading research-based MA organization. As such (s)he will help create and execute a strategy for the future evolution of GMA building on existing strengths while identifying key areas for improvement and implementing plans to address these elements.

SKILLS AND COMPETENCIES:

• M.D. or equivalent degree from a recognized medical school. Additional advanced degrees, entry on a Specialist Register (Pharmaceutical Medicine or a relevant clinical specialty) and a current ‘license to practice’ are a strong plus.
• Minimum 5 years of experience in global biopharmaceutical industry in Clinical Development and/or Medical Affairs.
• Minimum of 3 years of people management experience running a large organization of healthcare professionals.
• Demonstrated effective organizational skills, including ability to set goals and align priorities.
• Experience in one of the following fields: Oncology, Infectious Diseases Treatment, Vaccines, or Specialty care. Experience in Oncology is a strong plus.
• Preferred:
• As noted above, an advanced degree (MPH, Ph.D., MBA, Degree in Health Administration or Economics)
• As noted above, experience in Oncology (in a hospital, in a biopharmaceutical company, or an academic institution) is preferred
• Strong understanding of the compliance environment in which Medical Affairs functions.
• Business acumen, ethics and credible reputation with the external scientific community.
• Successful leadership and expertise in management of a Medical Affairs team.
• Experience in the development or field management of interventional/non interventional clinical studies.
• Ability to simplify and convey complex concepts and strategies, orally and in writing. Effectively conducts/facilitates meetings. Strong presentation skills.
• Demonstrated creativity and effectiveness in addressing strategic challenges. Possesses an entrepreneurial mindset; capable of thinking out of the box and taking measured risks.
• Experience working in global and regional medical affairs functions.
• Able to understand issues across a global affiliate network and contribute relevant insights as appropriate.
• Comfortable managing a matrix organization.
  Current Employees apply HERE
  Current Contingent Workers apply HERE

TRAVEL REQUIREMENTS:

50%

DUTIES AND RESPONSIBILITIES:

The Medical Director is responsible for oversight of all aspects of local Medical Affairs (MA), including:

• Country MA team focus on local MA strategy, with a heavy emphasis on helping to develop global MA strategy, support of strategic planning for medical support of Company objectives.
• Strategic planning and support of structured and consistent Continuous Medical Education (CME) activities.
• Strategic planning and support of Company interactions with Authorities and relevant Organizations at all levels.
• Building of close relationships with regulatory, GCTO departments.
• Consulting cross functional teams on medical and scientific matters.
• Providing input into local study feasibility and sites selection and implementing publication policy.
• Providing medical and scientific advice to business units, market access functions and others as required, as well as input into Health Economics. Also serving as a member of the local leadership team.
• Managing the country developed Protocol Concept Sheets (PCS) and obtaining regional and global) approvals for new local studies, if applicable.
• Review and approval of local study protocols and IISPs.
• Ensuring compliance with all applicable country regulations; developing relationships with regulatory authorities in collaboration with the local head of regulatory.
• Overseeing all activities of local Medical Department employees.
• Overseeing inspections and answering inquiries by health authorities and ethical committees, in conjunction with Regulatory, PV and GCTO.
• Enhancing the company reputation and profile through an external focus, by representing the company on cross-company boards and industry associations, represents the Company in mass-media (in collaboration with External Affairs/Policy).
• Orchestrate regional input for medical priority setting and co-sponsor the regional medical affairs planning teams to have bi-directional communication with HQ.
• May serve as subject matter expert for one therapeutic area for the country

(S)he will be the primary country level contact for medical affairs. (S)he is responsible for

• Oversight of the development and execution of the Medical Affairs (MA) strategy for the country, based on understanding of global, regional and local opportunities and requirements;
• creating and maintaining a high performing, highly compliant MA organization for the country
• representing local opportunities, requirements and needs at the regional and/or global levels, as appropriate;
• representing company in external activities requiring the presence of the country’s (or cluster’s) Senior Medical Leader; and
• coordinating with the country or cluster GCTO, Pharmacovigilance, and (where applicable) CORE, BARDs to ensure well-functioning interactions between company and external in-country stakeholders
• managing the entire portfolio for our company, allocating resources balancing global and local priorities. (S)he builds on existing capabilities through internal development and external hiring, analyzes and fills gaps by reallocating resources and creates an empowering, compliant, collaborative, and innovation-focused work environment.
• managing the medical aspects of submissions for reimbursement or tenders for entire portfolio of medicines and vaccines (collaboration with CORE, market access, and commercial colleagues)