Sr. Medical Affairs Director South Africa at MSD

Our Medical Affairs team advances patient care by engaging in scientific exchange with external medical experts and industry professionals ensuring the scientific value of our products is realized. We engage and train internal employees to ensure that they thoroughly comprehend the science behind the medicine and review further unmet medical needs to bolster collaboration and further differentiate our portfolio. 

Role Summary

• The South Africa (SA) Medical Director (CMD) is the Senior Medical Leader for our company in a country and serves as the leader of the medical affairs organization in their geography

CMD is the primary country level contact for Medical Affairs (MA) and has the following key responsibilities:

• Develops and executes the 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 {the research arm of the Company, or Medical Affairs} in the country Leadership Team and in cross-functional collaborations with other functions, Human Health (HH), and others
• 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

• Proactively manages and develops talent
• Proactively identifies new opportunities and gaps vs. emerging needs and addresses in a timely manner by reallocating and training of existing staff and/or external recruitment
• Creates an empowering, compliant, collaborative, and innovation-focused work environment
• Builds a culture of quality and compliance through training, oversight, and collaboration

Country Medical Affairs Plans (CMAPs)

• Strategically develops, executes, and delivers CMAPs, including tactical deliverables for each therapeutic area, such as post-licensure research, publication plans, investigator-initiated studies, and other knowledge transfer activities
• Ensures alignment of the CMAPs with global strategy and adherence to all relevant regulations, Policies and Standard Operating Procedures (SOPs)
• Manages the country-developed Protocol Concept Sheets (PCS), obtains regional and global approvals for new local data generation activities, and manages their execution

Medical Affairs Management

• Provides oversight to the country medical information team, establishes processes and systems to ensure that medical information requests (MIRs) from healthcare professionals are addressed in a timely manner and in alignment with the global scientific response documents and training materials
• Manages approved operating administrative (e.g., salaries & travel) and life cycle management budget (e.g., advisory boards, local data generation, etc.)
• Oversees all activities of local medical department employees
• Oversees inspections and inspections audits, answering inquiries by health authorities, ethical committees, and internal auditors in conjunction with Regulatory, Pharmacovigilance (PV) and Global Clinical Trial Operations (GCTO)

Collaboration With Key Internal Stakeholders

• The CMD represents Medical Affairs in cross-functional leadership teams and collaborations and advocates for the interests of the country with regional and global colleagues

Country Leadership Team

• Represents Medical Affairs and is the “medical voice” in the country executive management team

Global Clinical Development (GCD), Global Clinical Trial Operations (GCTO), and Global Clinical Scientific Affairs (GCSA)

• Supports GCTO when requested
• Manages the submission and roles in the conduct of investigator-initiated studies
• Leads country review of Compassionate Use Requests and Pre-License Patient Access (PLPA) programs and facilitates Chief Medical Officer (CMO) approval of these requests

Center for Observational and Real-World Evidence (CORE), Market Access, Regulatory Affairs, HH, and Policy

• Interacts with CORE, Market Access, and Global Medical Affairs experts to develop and manage observational, real-world effectiveness and epidemiologic studies
• Collaborates with CORE, 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’s entire portfolio of medicines and vaccines
• Provides 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.

• Serves 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, scientific leader (SL) engagements, webinars, and presentations)
• Collaborates with CORE, 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
• Builds a network of key scientific leaders in areas of relevance to current and anticipated needs
• Develops and/or fosters 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
• Participates in outcomes research/health economics engagements with national payers, Health Technology Assessment (HTA) or regulatory agencies, in coordination with CORE, Market Access, and Commercial colleagues
• Provides scientific subject matter expertise for media relations and public affairs to country Communications, Corporate/External Affairs, and Public Relations teams and serves as official spokesperson for scientific matters

Required Qualifications, Skills, & Experience

Minimum

• MD or equivalent degree
• Global biopharmaceutical industry experience in clinical development and/or medical affairs with demonstrated track record of success: [refer to table below for requirements by type of role]
• People-management experience: [refer to table below for requirements by type of role]
• Demonstrated organizational skills, including ability to set goals and align priorities
• Deep experience in our company’s 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’ (strong plusses)
• Specialty clinical training (e.g., a residency +/- fellowship)