Medical Affairs Indication Lead
We are seeking a highly skilled Medical Affairs Indication Lead to join our team in driving 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, 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 Emerging Markets.
Key Responsibilities:
* Developing and executing thought leader/key influencer strategies.
* Planning, developing, and executing Phase 3 and 3B through Phase 4 clinical research, RWE trials, ensuring the clinical program includes a robust holistic evidence package.
* Applying Next Generation Development into launch planning and execution.
* Medical and disease state education, publications, medical information, and medical affairs advisory boards.
* Collaborating with brand teams for launch preparation and serving as the primary medical leader for commercial-related activities, providing input for the following brand development activities.
* Focusing on product launches in the US and EU, and (as appropriate) Japan, Canada, Australia, China, and other key IBU countries. Serving as a resource and advocate for affiliates and regional medical affairs teams. Relaying their needs back to the global team (including alliances). Being aware of and ensuring 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.
The ideal candidate will possess a strong background in clinical research or pharmaceutical medicine, with therapeutic expertise and knowledge of disease states or indications strongly preferred. The ability to earn credibility and trust with thought leaders is essential, along with excellent interpersonal, organizational, and negotiation skills.
This role requires a Medical Doctor, Doctor of Osteopathy, Pharm Doctor, or PhD degree with board eligibility or certification, or equivalent stature if non-US trained. A minimum of 5 years' experience in clinical research or pharmaceutical medicine is required, with knowledge of drug development process, health policy, health outcomes, statistics, payers, and/or healthcare organizations desirable.