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Medical Affairs Indication Lead
Our client, a global pharma company, is currently recruiting for a Medical Affairs Indication Lead to join a new team on a very interesting project. As Medical Affairs Indication Lead, you will provide strong leadership and deliver successful launches through individual contributions and influence on the compound team. You will facilitate planning and execution in conjunction with the commercial and clinical teams, including specific working groups such as Marketing, Payer and Reimbursement Access, Medical Education, Medical Information, Advocacy and Professional Relations, Real World Evidence, Central Medical Capabilities, and Scientific Data Disclosure. You will collaborate across geographies with Medical Affairs teams in the US, ACE (Australia, Canada, and Europe), Japan, and Emerging Markets.
Responsibilities
1. Development and execution of thought leader/key influencer strategy
2. Planning, development, and execution of Phase 3 and 3B through Phase 4 clinical research, RWE trials, ensuring the clinical program includes a robust holistic evidence package
3. Applying Next Generation Development into launch planning and execution
4. Medical and disease state education, publications, medical information, and medical affairs advisory boards
5. Collaborate with brand teams for launch preparation and serve as the primary medical leader for commercial-related activities, providing input for brand development activities
6. Foundational insights for patients, providers, and payers (patient segmentation, patient journey, environmental evolution, etc.)
7. Core brand development (global positioning, global brand planning, etc.)
8. Commercialization activities and program development (customer council, brand planning, etc.)
9. Focus on product launches in the US, EU, and other key countries such as Japan, Canada, Australia, China, ensuring compliance with GCPs, company standards, policies, and the Principles of Medical Research. Relay regional needs to the global team and ensure activities align with the medical vision.
10. Accountable for launch readiness capability assessment for Global and US Medical Affairs, including preparing medical launch readiness plans with capacity, tactics, and OPEX recommendations
11. Contribute to overall product launch and medical affairs strategies to support commercialization, working closely with global and regional teams
12. Lead and drive completion of launch readiness activities such as education, thought leader engagement, scientific training, and medical FAQ development
13. Align clinical strategy and plans across business units and globally
14. Maintain updated knowledge of preclinical and clinical data relevant to the molecule
15. Develop and maintain a Draft Launch Label and Value Proposition addressing customer needs and product lifecycle considerations
16. Address customer questions timely through data analysis and research efforts
17. Identify and engage key thought leaders and maintain relationships with advocacy groups and professional societies
18. Plan and oversee execution of non-registration studies relevant for launch and patient outcomes
19. Support strategic planning for brand and lifecycle management
20. Support B2B and B2G activities as a medical expert
21. Review and approve promotional materials and tactics, support customer research, and train medical personnel
22. Manage scientific disclosure plans, ensure compliance with policies, and address external HCP information needs
23. Assist in medical information material review, scientific information response, and publication development
24. Read relevant medical literature, stay informed of developments, and represent the medical team externally and internally
25. Supervise clinical research staff if applicable, and support budget management for clinical trials
26. Set and meet professional development goals, contribute to team development, participate in recruitment and diversity efforts, and model leadership behaviors
Requirements
* Medical Doctor, DO, PharmD, PhD, with board eligibility or certification (preferred), or equivalent
* For non-US trained physicians, completion of education at an LCME-accredited medical school
* Minimum 5 years of clinical research or pharmaceutical medicine experience; therapeutic expertise preferred
* Knowledge of medical affairs, drug development, and experience with the brand preferred
* Experience in health policy, health outcomes, statistics, payers, or healthcare organizations is desirable
* Proven track record engaging with thought leaders, strong ethics, patient focus, and credibility
* Fluent in English (written and verbal)
* Interpersonal, organizational, and negotiation skills; excellent teamwork and collaboration skills
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