Role Summary:
- The Country Medical Director (CMD) is the Senior Medical Leader for our company in a country and serves as the leader of the Value & Implementation (V&I) Global Medical Scientific Affairs (GMSA) organization in their geography.
- CMD is the primary country level contact for GMSA.
Key responsibilities:
- Coordinates Development and execution of the Medical Affairs (MA) strategy for the country.
- Creates and maintains a high-performing, highly-compliant MA organization for the country.
- Manages the entire portfolio for our company, allocates resources balancing global and local priorities.
- Represents our Research Laboratories or GMSA in the Country Leadership Team; and in cross-functional collaborations with other research lab functions.
- Communicates accomplishments, opportunities, and needs of the country to regional and/or global stakeholders;
- Represents our company in external activities requiring the leadership and expertise of the country’s Senior Medical Leader.
Responsibilities and Primary Activities:
Leadership and Management of the Medical Affairs Organization:
- People:
- Lead in a matrix organization thru shared leadership with TA Leads, Medical Advisers based in the country;
- Proactively identify new opportunities and also gaps vs emerging needs and address in a timely manner by reallocating and training of existing staff and/or external recruitment;
- Create an empowering, compliant, collaborative, and innovation-focused work-environment;
- Build a culture of quality and compliance through training, oversight, and collaboration.
- Country Medical Affairs Plans (CMAPs):
- Coordinate the development and execution of CMAPs, including tactical deliverables for each of the therapeutic areas, such as post-licensure research, publication plans, investigator- initiated studies, and other knowledge transfer activities.
- Ensure alignment of the CMAPs with global strategy and adherence to all relevant regulations, Policies and Standard Operating Procedures (SOPs).
- Coordinate the country developed Protocol Concept Sheets (PCS), obtain regional and global approvals for new local and manage their execution .
- Medical Affairs Management:
- Manage approved operating administrative (e.g. salaries & travel) and life cycle management budget (e.g. Advisory boards, Local Data Generation etc.);
- Oversee inspections and inspections audits, answering inquiries by health authorities, ethical committees, and internal auditors in conjunction with Regulatory, PV and Global Clinical Trial Operations (GCTO).
Responsibilities and Primary Activities, continued
Collaboration with Key Internal Stakeholders
The CML represents Medical Affairs in cross-functional leadership teams and collaborations, and advocates for the interests of the country (or cluster) with regional and global colleagues.
- Country Leadership Team:
- Represent Medical Affairs and be the “medical voice” in the country executive management team.
- Global Clinical Trial Operations (GCTO), Global Regulatory Affaris & Clinical Safety (GRACS):
- Support for GCTO when requested;
- Manage the submission and our research lab roles in the conduct of Investigator-Initiated Studies;
- Lead country review of Compassionate Use Requests and Pre-License Patient Access (PLPA) programs and facilitate Chief Medical Officer (CMO) approval of these requests.
- Support to the Local QPPV as medical qualified person.
- Outcome Research (OR), Market Access, Regulatory Affairs, HH and Policy:
- Interact with OR, Market Access, and Global Medical Affairs experts to develop and manage observational, real-world effectiveness and epidemiologic studies;
- Collaborate with OR, market access, regulatory and commercial colleagues by providing scientific expertise and managing the medical aspects of submissions for regulatory, reimbursement or tenders for our company entire portfolio of medicines and vaccines;
- Provide medical expertise to the commercial product teams, ensuring the scientific and medical value of our company’s products across all therapy areas.
Engagement with Key External Stakeholders:
The CMD represents our company as an executive leader and scientific expert to the external community.
- Serve as external interface with key stakeholders, insurers/government leaders, selected professional societies, medical-scientific institutions and the broader scientific community to lead and execute the medical research and implementation strategy for our company’s innovative medicines, ensuring that the medical community is appropriately engaged with the information they need to support patient care needs (e.g., scientific advisory boards, SL engagements, webinars and presentations).
- Collaborate with OR, Market Access, and Commercial colleagues to engage payers, policymakers, and other decision-makers in support of our company´s innovative portfolio of medicines and vaccines.
- Build a network of key scientific leaders in areas of relevance to current and anticipated needs.
- Develop and/or foster relationships with external stakeholders to ensure that robust local insights from Health Care Providers (HCPs) and patients are gathered and integrated into local, regional and/or global strategies, plans and tactics, enabling the generation of data needed by payers, physicians, and patients to properly understand and value our innovative medicines and vaccines.
- Participate in outcomes research/ health economics engagements with national payers, Health Technology Assessment (HTA) or regulatory agencies, in coordination with OR, Market Access, and Commercial colleagues.
- Provide scientific subject matter expertise for media relations and public affairs to country Communications, Corporate/External Affairs, and Public Relations teams; and serve as official spokesperson for scientific matters.
Required Qualifications, Skills & Experience:
Minimum:
- M.D. or equivalent degree;
- Global biopharmaceutical industry experience in clinical development and/or medical affairs with demonstrated track record of success: minimum 7 years
- People-management experience: minimum 5 years
- Demonstrated organizational skills, including ability to set goals and align priorities;
- Deep experience in our company therapeutic areas of interest (e.g., oncology, infectious diseases treatment, vaccines, or specialty care);
- Budget management experience.
Preferred:
- 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;
- Specialty clinical training (i.e., a residency +/- fellowship).
HOW TO APPLY: Please send your CV to the consultant in charge:
Ms. Thao Vo
Email: thao.vo@ev-search.com
All applications will be considered without regard to race, color, religion, sex (inclusing pregnancy and fender identity), national origion, political affiliation, sexual orientation, mariatal status, disability, genetic information, age, membership in an employee organization, parental status, military service or other nonmerit factor
