Lilly depends on successful launches for multiple products across many therapeutic areas and geographies. Optimal launch preparation strategies and processes are critically important .The external environment is rapidly changing and continues to grow in complexity. Access to medicines and price/reimbursement has an increasingly higher level of importance and our health care professional (HCP) customers are demanding more real-world, evidence-based research studies, therapies, and solutions. We must introduce ourselves to those and other customers in a way that establishes meaningful relationships, helps them understand the context and therapeutic value of our medicines and services, and prepares for their questions.
A successful launch requires competence in several specialized areas, including unlocking payer access and having effective commercialization plans in diverse health care ecosystems. It also includes the need to further study molecules as they are utilized according to their approved indications to advance understanding of benefit-risk in the context of other available treatment options. The medical affairs CRP will provide strong leadership and support for launches, including publications, IIT programs, Phase IV studies and collaborative research.
In close partnership with clinical development and MDU functions, the CRP will participate in the planning and execution of holistic evidence research. Close collaboration will also be required with the Global Brand Development (GBD) Medical Director; Regional Therapeutic Area Medical Leaders; Affiliate Medical Directors, physicians, and scientists; commercial teams and MDU teams including health outcomes, project management, statistics, and other functions. The CRP will actively consult and contribute to the development and implementation of Phase IV studies.
The primary deliverables of this role will be
Support the development and implementation of the medical affairs launch strategy, including responsibility for ensuring that the needs and education of payers, prescribers, and the other nonregulatory stakeholders who influence patients' treatment access or benefits are met. Key activities include
Development and execution of thought leader/key influencer strategy
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.
Medical and disease state education, publications, medical information, and medical affairs advisory boards
Development of content to support internal training, responses to HCP unsolicited requests for information, and other medical resources
Collaborate with GBD and affiliate/regional brand teams for launch preparation and serve as the primary medical leader for commercial-related activities, providing input for the following brand development activities.
Foundational insights for patients, providers, and payers (patient segmentation, patient journey, environmental evolution, etc)
Core brand development (global positioning, global brand planning, etc)
Commercialization activities and program development (customer council,brand planning, etc)
Support priority product launches in the US, Japan, China and EU, and other key International Business Unit (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).
Thought Leader Engagement
Responsible for identifying, understanding, and engaging key thought leaders
Accountable for design and implementation of the thought leader engagement strategy and plan; will seek consultation and collaboration from Global Marketing team, GBD Medical Director, Global PRA, the Thought Leader Capability Office, GPROWE and Regional/Affiliate Medical Affairs teams
As appropriate, identify and collaborate with external scientific experts and thought leaders who share our mission and an interest in our work
Interact with Advocacy and Professional Relations and maintain relationships with advocacy groups and professional societies
Be aware of and ensure that medical affairs activities are "in compliance with Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, company integrity agreements as applicable, and the Principles of Medical Research, and that activities are aligned with the medical vision.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
Medical Doctor or Doctor of Osteopathy. Must be board eligible or certified in appropriate specialty/subspecialty or have completed the comparable level of post-medical school clinical training relevant to the country of hiring.
U.S. trained physicians must have achieved board eligibility or certification.
Foreign medical graduates (in U.S. based jobs) who are not U.S. board eligible or certified may be hired directly for employment in the U.S. at the discretion of the Chief Medical Officer.
Non-U.S. trained physicians must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME). For the recognized list of foreign medical schools and the disapproved list, see http://www.in.gov/pla/2799.htm
Minimum of 5 years clinical practice and/or research, oncology, immuno-oncology or immunology preferred
Eli Lilly And Company