The Medical Director, ( Global Medical Affairs), for avelumab is a core member for the asset leadership team, working in close partnership with the GMAL, Regional Medical Affairs Leads, Global Clinical Lead (GCL), IIR Manager, and Global Commercial Lead, and with relevant counterparts at EMD Merck Serono. The Med Dir is responsible for external-facing interactions with medical experts and other stakeholders, and is expected to build and maintain strong opinion leader relationships. The GMAL engages in external collaborations in order to gain insight and to facilitate clinical development and life cycle plans.
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Responsibilities
1. Develop an aligned Global Medical Affairs strategy. Key deliverables include:
a. Lead the Global IIR Strategy
b. Medical Lead for avelumab Review Committee
c. Global Advisory Board Plan
d. Publication Plan
e. Global MA Budget.
2. Collaborate with cross-functional stakeholders on the global launch planning of avelumab in Merkel cell carcinoma, and other indications as appropriate including Regional Medical Affairs Leads, Global Clinical Lead, and Worldwide Commercial Development Lead. Represent Regional Medical Affairs priorities on the Asset Team. Support all aspects of launch planning, including close partnership with WWCD on promotional material, medical training, background material development, and attendance at key congresses, and interactions with experts, as appropriate.
3. Develop and communicate lifecycle planning and strategies
a. Collaborate with Asset Teams to support implementation, review, and communication of clinical studies
b. Provide insights into competitive landscape
4. Support launch planning
5. Participate in safety reviews of assigned assets)
a. Co-chair, with the Safety Risk lead, at least twice yearly meetings of the Product Benefit Risk committee (PBRC)
b. Assess new information potentially affecting interpretation of benefit and risk at ad hoc meetings, and present data to BU-BRC and EBRC, as needed
c. Ensure aligned risk benefit assessment from regional asset leads
6. Provide medical input to support the development of global regulatory documents
7. Lead global IIRs:
a. Develop and communicate a global IIR strategy:
b. Chair Global Review Committee (GRC) for review of IIR proposals
c. Lead review of ongoing IIR performance
d. Support the communications of results from IIRs to key internal stakeholders
e. Serve as medical Project Lead for selected Clinical Research Collaboration (CRC) studies
8. Develop, communicate, and implement global publication plan:
a. Chair Publication Subcommittee (PSC)
i. Ensure the development of a comprehensive asset global
publication plan in collaboration with Global Medical Communications team
ii. Collaborate with internal and external stakeholders to ensure execution to plan while maintaining compliance with Pfizer publication policies and procedures.
b. Work with the Asset Team and Global Medical Communications team to identify time points at which data suitable for publication will be available and supports their presentation and publication
c. Partner with Global Medical Communications on the development and execution of plans
9. Develop opinion leader relationships
a. Work with the regions to identify key opinion leaders
b. Work with Asset Team to identify questions and issues about the asset for which advisory board input could be useful
10. Global Advisory Board support and execution
a. Develop Advisory board strategy and materials in conjunction with the GCL, ATL, and clinical team.
b. Support the regions in the conduct of regional advisory boards through development of key slides and questions, and occasional participation
c. Partner with Global Medical Communications and regional Medical Affairs organizations in liaising with key opinion leaders and in the development and execution of plans
11. Interface with regional Medical Affairs teams
a. Partner closely with regional Medical Affairs representatives to ensure that regional needs are met by clinical development and global life cycle plans
b. Partner with regional Medical Affairs in supporting IIR programs
c. Prioritize, align and support global KOL interactions and activities
d. Support regional publication needs in the context of a strategic global publication plan
12. Partner with Corporate Affairs group to develop communication materials and support external communications
13. Will apply clinical knowledge as needed.
Qualifications
MD
At least 5 years of Medical Affairs experience in Pharma
Minimum 3 years of Oncology experience
• Strong oral and written communication skills to interact with internal and external stakeholders
• Strong interpersonal skills to quickly build rapport and credibility with Pfizer leaders and key external stakeholders
• Understanding of principles of pharmacovigilance and risk/benefit analysis
• Global mindset and experience in multiple markets, proven ability to partner cross culturally/regionally
• In-depth understanding and experience with study methodology, protocol design, safety evaluation, and data analysis
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Regular work.
Travel ( at least 1 / per month domestically), and possibly 3 to 4 international trips annually are to be expected.
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