Medical Affairs Director SEE Cluster

Job DescriptionThe Medical Affairs Director is the Senior Medical Leader for our Company in the SEE cluster (Serbia, Croatia, Bulgaria, Slovenia, Bosnia, Albania, Nth Macedonia, Montenegro and Kosovo). (S)he reports directly to the Executive Medical Director for Baltics, CEE and SEE. S(he) leads a Team of Team Leaders, namely Associate Directors who are leading the Medical Advisors in the cluster countries.

(S)he is responsible forBeing the Medical representative in the SEE Leadership teamBeing the Medical Representative in the Country Leadership Teams in Bulgaria Serbia and Slovenia/Croatia (with option to delegate this role to a country ADMA where appropriate whilst maintaining oversight and accountability)Oversight of the development and execution of the Medical Affairs (MA) strategy for the country or cluster, based on understanding of global, regional and local opportunities and requirementscreating and maintaining a high performing, highly compliant MA organization for the country or clusterrepresenting local opportunities, requirements and needs at the regional and/or global levels, as appropriateMedical Representative in the SEE Medical Governance Councilrepresenting our Research & Development Division in the Country or Cluster Leadership TeamRepresenting our 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, or DPED staff to ensure well-functioning interactions between our Company and external in-country stakeholdersManaging 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 environmentManaging the medical aspects of submissions for reimbursement or tenders for our Company’s entire portfolio of medicines and vaccines (collaboration with CORE, market access, and commercial colleagues). As part of the Leadership of our Research & Development Division GMSA, the Country Medical Director (Director) will assist in maintaining our Research & Development Division GMSA as a leading research-based MA organization.

As such (s)he will help create and execute a strategy for the future evolution of GMSA building on existing strengths while identifying key areas for improvement and implementing plans to address these elements.

Key ResponsibilitiesThe Medical Director is responsible for oversight of all aspects of Cluster and local Medical Affairs (MA) in the SEE countries, includingCountry MA team focus on local our Research & Development Division MA strategy, with a heavy emphasis on helping to develop global MA strategy, support of strategic planning for medical support of Company objectivesStrategic planning and support of structured and consistent Continuous Medical Education (CME) activitiesStrategic planning and support of Company interactions with Authorities and relevant Organizations at all levelsBuilding of close relationships with regulatory, GCTO departments.

Consulting Business Units on medical and scientific mattersProviding input into local study feasibility and sites selection and implementing publication policyProviding 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 teamManaging the country developed Protocol Concept Sheets (PCS) and obtaining regional and global) approvals for new local studiesReview and approval of local study protocols and IISPsAdvising business units on medical and scientific matters, including—but not limited to—scientific approval of promotional materialsEnsuring compliance with all applicable country regulations; developing relationships with regulatory authorities in collaboration with the local head of regulatoryOverseeing all activities of local Medical Department employeesOverseeing inspections and answering inquiries by health authorities and ethical committees, in conjunction with Regulatory, PV and GCTOEnhancing 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 PR Manager)Orchestrate regional input for medical priority setting and co-sponsor the regional medical affairs planning teams to have bi-directional communication with HQMay serve as subject matter expert for one therapeutic area for the country or cluster.

RequiredQualifications, Skills & ExperienceM. 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 plusMinimum 5 years of experience in global biopharmaceutical industry in Clinical Development and/or Medical AffairsMinimum of 3 years of people management experience running a large organization of healthcare professionalsDemonstrated effective organizational skills, including ability to set goals and align prioritiesExperience in one of the following fields Oncology, Infectious Diseases Treatment, Vaccines, or Specialty care. Experience in Oncology is a strong plus.

PreferredAs 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 preferredStrong understanding of the compliance environment in which Medical Affairs functionsBusiness acumen, ethics and credible reputation with the external scientific communitySuccessful leadership and expertise in management of a Medical Affairs team. Experience in the development or field management of interventional/non interventional clinical studiesAbility to simplify and convey complex concepts and strategies, orally and in writing. Effectively conducts/facilitates meetings.

Strong presentation skillsDemonstrated creativity and effectiveness in addressing strategic challengesPossesses an entrepreneurial mindset; capable of thinking out of the box and taking measured risksExperience working in global and regional medical affairs functionsAble to understand issues across a global affiliate network and contribute relevant insights as appropriateComfortable managing a matrix organization. Current Employees apply HERECurrent Contingent Workers apply HERESearch Firm Representatives Please Read Carefully Merck & Co. , Inc. , Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities.

All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status RegularRelocation VISA Sponsorship Travel RequirementsFlexible Work Arrangements HybridShift Valid Driving License Hazardous Material(s) Required SkillsAdaptability, Adaptability, Advisory Board Development, Biopharmaceutical Industry, Clinical Development, Clinical Medicine, Decision Making, Expense Reimbursement, Healthcare Education, Health Economics, Hospital Medicine, Infectious Disease, Management Process, Medical Affairs, Medical Marketing Strategy, Medical Teaching, Multiple Therapeutic Areas, Oncology, People Leadership, Pharmaceutical Medical Affairs, Pharmacokinetics, Pharmacotherapy, Project Life Cycle Management, Reimbursement, Results-Oriented {+ 5 more}Preferred SkillsJob Posting End Date 08/12/2025A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date.

Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID R358479