Medical Affairs Indication Lead
Our client, a global pharma company, are 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 through influence on the compound team. You will facilitate planning and execution in conjunction with the commercial and clinical teams, which includes specific working groups (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 the 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 the following 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 and EU, and (as appropriate) Japan, Canada, Australia, China, and other key IBU countries. Serve as a resource and advocate for affiliates and regional medical affairs teams. Relay their needs back to the global team (including alliances). Be aware of and ensure that all medical affairs activities are in compliance with Good Clinical Practices (GCPs), company standards, policies and procedures, company integrity agreements as applicable, and the Principles of Medical Research, and that activities are aligned with the medical vision
10. Accountable for launch readiness capability assessment for Global and US Medical Affairs in collaboration with global and US brand development, project management, and commercialization teams; responsible for preparing global and affiliate medical/marketing teams with a medical launch readiness plan including recommended capacity, tactics, and OPEX to support a successful launch
11. Contribute to the development of overall product launch strategy and medical affairs strategies to support brand commercialization activities by working closely with the global brand, Advocacy and Professional Relations teams, appropriate affiliate or region medical/marketing/ clinical plans personnel, and other cross-functional management
12. Accountable to lead and drive to completion Global and US Medical Affairs launch readiness activities including education strategy and tactics, thought leader mapping/engagement, internal scientific and molecule training, medical FAQ development, Med Info/Medical Liaison training, and other key activities required for the successful launch of a product
13. Contribute to business unit and global alignment of clinical strategy and clinical plans
14. Understand and keep updated with the preclinical and clinical data relevant to the molecule
15. Consult in the development and maintenance of a Draft Launch Label and Value Proposition that addresses key customer needs (patient, provider, and payer), the product lifecycle plan, clinical strategies, development plans and benefit-risk assessments for patients, commercial potential, launch strategy, and implications to global core and key labels in major geographies
16. Anticipate and actively address customer (payer, patient, and HCP) questions in a timely fashion by leading data analyses; analyses of customer questions; and new clinical, health outcomes, or Real World Evidence research efforts
17. Responsible for identifying, understanding, and engaging key thought leaders
18. Interact with Advocacy and Professional Relations and maintain relationships with advocacy groups and professional societies
19. Understand and share broadly the scientific information needs of all customers (payers, patients, health care providers)
20. Accountable to plan and oversee execution of nonregistration studies necessary or relevant for launch and/or improved patient outcomes
21. Regularly consult on the strategic planning for the brand and on lifecycle planning
22. Support business-to-business and business-to-government activities as a medical expert
23. Review, offer scientific and/or medical comments, and approve promotional materials and tactics
24. Support the design of customer research as a medical expert
25. Support training of medical personnel, including Clinical Research Physicians and Scientists, medical and outcome liaisons, and health outcomes personnel
26. Responsible for the overall scientific disclosure plan (Senior Medical Director/GBD to retain authority/sign off on plan)
27. Ensure knowledge of and compliance with global policies and procedures, and compliance guidelines with respect to data dissemination and interactions with external HCPs
28. Understand and actively address the unsolicited scientific information needs of external HCPs according to the guidelines above
29. Support medical information associates in preparation and review of medical letters and other medical information materials
30. Prepare and/or review scientific information in response to customer questions or media requests
31. Support data analysis and the development of slide sets and publications (abstracts, posters, manuscripts)
32. Critically read the relevant medical literature, know the status and data from competitive products, and maintain knowledge of medical and other scientific developments relevant to the product
33. Represent the organisation and its Medical team as a credible colleague and scientific expert in the external and internal scientific community; work closely with development team to ensure the implication of clinical trial results and conclusions are understood and the external opinions in these conclusions are included
34. Be aware of current trends and projections for clinical practice and access
35. May provide direct supervision to assigned clinical research physicians, clinical research scientists, and an administrative assistant
36. Support the management team, in preparation and administration of the business unit development budget, especially as it pertains to Phase 3B or Phase 4 trials
37. Actively set and meet individual professional development goals and contribute to the development of others by being an active source of coaching and feedback
38. Actively participate in recruitment, diversity, and retention efforts
39. Model the leadership behaviors of and be an ambassador for the organisations brand
Requirements:
40. Medical Doctor, Doctor of Osteopathy, Pharm Doctor or PhD degree with board eligibility or certification (preferred), or equivalent stature if non-US trained
41. Non-US trained physicians must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME)
42. Minimum of 5 years clinical research or pharmaceutical medicine experience required Therapeutic expertise and knowledge of disease state or indication of molecule studied strongly preferred
43. Knowledge of medical affairs required, and substantial experience preferred with the brand
44. Knowledge of drug development process required
45. Experience desirable in health policy, health outcomes, statistics, payers, and/or healthcare organizations
46. Excellent track record in personal engagement with thought leaders
47. Strong ethics, patient-focus, and ability to earn credibility and trust
48. Fluent in English, both written and verbal communications
49. Interpersonal, organizational, and negotiation skills
50. Excellent teamwork skills, including working with those from different background