Country Medical Director

Job Description

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we follow the science that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

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.

As the Country Medical Director (CMD) and Senior Medical Leader for our company in Israel you will lead the Medical Affairs organization and serve as the primary country-level contact for Medical this role you will develop and execute the Medical Affairs strategy for the country build and sustain a high-performing highly compliant Medical Affairs organization manage our full portfolio and allocate resources to balance global and local priorities; represent the research arm of the company or Medical Affairs on the country Leadership Team and in cross-functional collaborations with other functions; communicate the countrys accomplishments opportunities and needs to regional and global stakeholders; and represent our company externally in activities requiring the leadership and expertise of the countrys Senior Medical Leader.

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

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

• Interact with CORE Market Access and Global Medical Affairs experts to develop and manage observational real-world effectiveness and epidemiologic studies

• Collaborate 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 companys entire portfolio of medicines and vaccines

• Provide medical expertise to the commercial product teams ensuring the scientific and medical value of our companys 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 companys 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 companys 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 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

What You Will Need:

• MD or equivalent degree

• Global biopharmaceutical industry experience in clinical development and/or medical affairs with demonstrated track record of success

• People-management experience

• Demonstrated organizational skills including ability to set goals and align priorities

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Required Skills:

Preferred Skills:

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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.

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Relocation:

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