Global Medical Affairs Director Oncology

A job vacancy for a Global Medical Affairs Director Oncology has arisen at a leading global pharmaceutical company specialising in development of biological therapies. This company is one of the top 10 global pharmaceutical companies that operates in 140 countries worldwide and has market leading products in multiple therapy areas.

Job Responsibilities:

• Developing study-related documents (e.g. concept sheets, protocols, case report forms, statistical plan, data analysis plan, study reports, and publications).
• Developing and reviewing presentation materials for study/program-related advisory boards, investigator meetings, protocol training meetings for AAA local medical organizations, and external speaker at meetings when required.
• Reviewing clinical study data, final analysis, and interpretation, in collaboration with the Brand Safety Leader, appropriate Global Clinical Team (GCT) members and the GBT (Global Brand Team).
• Acting as medical key contact point for assigned Medical Affairs (MA) studies.
• Serving as a disease area scientific and medical expert for internal customers/stakeholders, e.g., GCT, Commercial teams, AAA Local Country Organizations , and other line functions within the company and external customers e.g., Health Care Professionals (HCPs), Market Access and Patient Advocacy Groups (PAGs).
• Building Global Medical Affairs Therapeutic Area Medical Strategy.
• Providing support on the Medical Affairs Plan and other company line functions plans (Data generation, Medical Training, Medical Excellence, etc.).
• Providing input on scientific content of Program/brand(s) publication plan.
• Supporting/leading data mining and Real-World Evidence (RWE) activities.
• Leading the RWE project planning process.
• Providing medical support/input for internal and external medical education and communication initiatives (e.g., speaker training, advocacy, Medical Experts strategy, advisory boards, MSL support and education, launch support, congress planning, and execution).
• Providing inputs to develop compound and/or disease area-related scientific training materials.
• Providing the medical input to MSL materials and related activities and supporting the development of these deliverables in cooperation with other company lines.
• Providing medical scientific input for the assigned program/brand(s) to:
• Develop integrated Product Strategy (IPS), MA strategy and related MA plan.
• Develop Clinical Development Plan (CDP section related to MA activities).
• Guide and develop local MA clinical programs and provide support in execution.
• Value dossiers and participation at payer advisory boards.
• Contributing to Medical Affairs Data Generation Team to provide guidance related to MA data generation plans; review, approve, and follow up.
• Providing medical inputs to prepare Global guidance documents for running MA data generation activities.
• Providing medical/scientific support for Medical Science Liaisons (MSLs).
• Providing medical input in Periodic Safety Update Reporting (PSURs) and Development Safety Update Reporting (DSURs).
• Providing input ensuring compliance of promotional and non-promotional global material and all Medical Affairs activities.
• Providing input into brand safety related activities for the assigned program; PSURs/DSURs.
• Providing input into Global brand team (GBT) and Global Clinical Development team (GCD); Global Brand Planning, Clinical Development Plans, internal decision boards as the Medical Affairs advocate.
• Contributing to talent and career development of MA team members through active participation in on-boarding, training and mentoring activities where relevant.

Skills and Requirements:

• MD or PhD with knowledge with ≥ 10 years of medical affairs experience at Country, Region and Global level roles in Pharma Industry.
• Advanced medical/scientific writing and communication skills.
• Demonstrated ability to establish strong scientific partnership with HCPs and Investigators in assigned TA.
• Medical and/or scientific expertise within Therapeutic area required. Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Tom Russell at +44 203 824 6104 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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