Senior Director Medical Affairs

Job Description

What You Will Do

• Leadership of the Medical Affairs Organization
• **People**
• + Proactively manage and develop talent, whilst identifying new opportunities vs. emerging needs by reallocating resources, upskilling the team and recruiting
• + 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)**
• + Strategically develop, execute, and deliver CMAPs, including tactical deliverables for each therapeutic area, 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)
• + Manage the country-developed Protocol Concept Sheets (PCS), obtain regional and global approvals for new local data generation activities, and manages their execution
• **Medical Affairs Management**
• + Provide oversight to the country medical information team, establish 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
• + Manage 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

• You will represent Medical Affairs in cross-functional leadership teams and collaborations and advocate for the interests of the country with regional and global colleagues
• **Country (or Cluster) 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)**
• + Support GCTO when requested
• + Manage the submission and our roles in the conduct of investigator-initiated studies
• + Lead country review of Compassionate Use Requests and Pre-License Patient Access (PLPA) programs and facilitates Chief Medical Officer (CMO) approval of these requests
• **Outcomes 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’s 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

• 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 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
• 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 OR, 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

What You Will Need

• MD or equivalent degree
• Fluent in English; Arabic proficiency is preferred.
• Global biopharmaceutical industry experience of 5 years and above, in clinical development and/or medical affairs with demonstrated track record of success
• People-management experience of 3 years and above.
• Demonstrated organizational skills, including ability to set goals and align priorities

Required Skills

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Regular**Relocation:**

n/a**Job Posting End Date:**