Medical Director

Position: 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 Affairs. In 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 country’s accomplishments, opportunities, and needs to regional and global stakeholders; and represent our company externally in activities requiring the leadership and expertise of the country’s Senior Medical Leader.
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* 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…