Country Medical Director

2 meses atrás

Lisboa, Portugal Organon Tempo inteiro

The Position

The Country Medical Director (CMD) will be the primary country-level contact for the local medical organization. The Country Medical Director reports into the Regional Medical Directors/Heads and oversees Field Medical and Medical Services teams.

Responsibilities:

Country Medical team focusing on local Organon Medical strategy, with a heavy emphasis to help develop Global Medical strategy.

Supporting strategic planning and medical support of Company objectives.

Strategic planning and support of structured and consistent Continuous Medical Education (CME) activities.

Building close relationships with local Regulatory Agency.

Providing input into local study feasibility and sites selection and implementing publication policy.

Providing medical and scientific advice to business units, Market Access functions and others, as required, including input into Health Economics.

Serving as a member of the local leadership team.

Managing the country-developed Protocol Concept Sheets (PCS) and obtaining regional and global approvals for new local studies.

Reviewing and approving local study protocols and Investigator-Initiated Studies Programs (IISPs).

Advising business units on medical and scientific matters, including but not limited to scientific approval of promotional materials.

Ensuring compliance with all applicable country regulations and developing relationships with regulatory authorities in collaboration with the local head of regulatory.

Overseeing inspections and answering inquiries by health authorities and ethical committees in conjunction with Regulatory and Pharmacovigilance (PV).

Enhancing the company reputation and profile through an external focus by representing the company on cross-company boards and industry associations, including Company representations in mass media (in collaboration with PR Manager).

Orchestrating regional input for medical priority setting and co-sponsoring the regional Medical Affairs planning team to have bi-directional communication with Headquarters.

Required Education, Experience, and Skills

MD, Pharm D or PhD required.

At least 5 years of experience in global biopharmaceutical industry in Clinical Development and/or Medical Affairs.

At least 3 years of people management experience, running an organization of healthcare professionals.

Demonstrated effective organizational skills, including ability to set goals and align priorities.

Experience in one of the following fields: Women's Health, Biosimilars Immunology/Oncology, Fertility.

Preferred Education, Experience, and Skills

Ability to communicate in English.

Strong understanding of the compliance environment in which Medical Affairs functions.

Business acumen, ethics and credible reputation with the external scientific community.

Experience in the development or field management of interventional/non-interventional clinical studies.

Ability to simplify and convey complex concepts and strategies, orally and in writing, and conduct/facilitate meetings with strong presentation skill.

Demonstrated creativity and effectiveness in addressing strategic challenges, an entrepreneurial mindset, and capability of thinking out of the box and taking measured risks.

Ability to understand issues across a global affiliate network and contribute relevant insights as appropriate.

High comfort level representing Medical Affairs at the (extended) Country Leadership Team.

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