EGM Regional Medical Director, Oncology

EGM Regional Medical Director, Oncology
Leads all aspects of the Emerging Growth Markets Region at a country, regional and global level with respect to all the medical/scientific activities, including planning and execution, in relation to designated therapeutic area. Medical activities comprise early and late development clinical studies, registration and non- registration (medical affairs) clinical programs, scientific communication, development of partnership with investigators and medical opinion leaders. Represents EGM on the extended GPT with the support of their manager, and to GMA (part of IDMT). Provides leadership to all of the Medical Advisors in the countries ac-countable for same products and diseases, whilst also interacting with GMO, RARM, finance, legal and compliance and within the M3 team (Medical, Marketing and Market Access).

A) Medical affairs activities

• Comprising of clinical studies, IITs, scientific communication, the development of partnerships with investigators and medical opinion leaders.

• Oversee medical activities that can connect compounds from phase I to LCM (life cycle management) and includes all aspects of scientific support and activities.

• Full accountability for strategic and tactical definition of the EGM clinical plan for brand / disease responsibility.

• Implement validated medical tactical plan (speaker tour, symposia, ad board, webcast, slide decks…).

• Present in medical education meetings, advisory board or road shows

• Remains up-to-date with the literature and is able to update the team on key scientific publications.

• Actively participates in, and champions publication requirements for EGM countries in the Global Publication Planning Meetings.

• Be the voice of medical in M3 work and collaboration –accountable for medical input in regional IDAPS and global IDAPS through active participation in IDMT meetings.

• Checks and contributes to alignment with the countries and with global and proactive in support any country or department to facilitate access to the brand.

• Provide training needed in country and at HQ, digital support, and specific medical pro-jects. B) Execution of OGD and Regional clinical programs

• Assist GMO in site selection, review feasibility within EGM countries, assist in ethic com-mittee, submission for OGD program

• Propose and is accountable for local execution of clinical trials in EGM. Evaluate local proposals – proposed regional ones aligned with strategic imperatives

• Participates actively in selection of appropriate study centers for EGM.

• Evaluate local IIT proposal – check MRC approval and follow up until publication

• Oversees the cooperation with the local colleagues and the external CRO for the performance of centers including trial initiation, patient recruitment and study closeout per plan. C) Compliance

• Overall responsibility for safety and quality standards.

• Ensure IIT handling in EGM according to the last Global SOP and regional working practice.
• BSc in Life Sciences and MD qualification preferred

• Fluent English (oral and written).

Experience/professional requirement:

• Minimum 5 years’ experience in Clinical experience (Clinical Development and Medical Affairs, with preference for the latter).
• Knowledge of clinical trials coordination and management, including CRO management
• Clinical practice experience in oncology / hematology is advantageous
• Strong ability in project management and problem solving
• Proven ability to write Clinical Study Protocols, reports and publications.
• Ability to recognize safety and efficacy data trends.
• Familiar with all aspects of the clinical development process.
• Knowledge of the medical, scientific and clinical research techniques of the assigned area.
• Knowledge of GCP and regulatory requirements.
• Ability to lead and work in teams and coach team members.
• Strong ability to work in matrix environments and in international teams
• Ability to give presentations during Advisory Boards and during meetings with physicians.
Novartis Pharma AG
Research & Development
Full Time