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

• 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.
• Applying Next Generation Development into launch planning and execution
• Medical and disease state education, publications, medical information, and medical affairs advisory boards
• 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
• 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.)
• 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
• 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
• 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
• 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
• Contribute to business unit and global alignment of clinical strategy and clinical plans
• Understand and keep updated with the preclinical and clinical data relevant to the molecule
• 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
• 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
• Responsible for identifying, understanding, and engaging key thought leaders
• Interact with Advocacy and Professional Relations and maintain relationships with advocacy groups and professional societies
• Understand and share broadly the scientific information needs of all customers (payers, patients, health care providers)
• Accountable to plan and oversee execution of nonregistration studies necessary or relevant for launch and/or improved patient outcomes
• Regularly consult on the strategic planning for the brand and on lifecycle planning
• Support business-to-business and business-to-government activities as a medical expert
• Review, offer scientific and/or medical comments, and approve promotional materials and tactics
• Support the design of customer research as a medical expert
• Support training of medical personnel, including Clinical Research Physicians and Scientists , medical and outcome liaisons, and health outcomes personnel
• Responsible for the overall scientific disclosure plan (Senior Medical Director/GBD to retain authority/sign off on plan)
• Ensure knowledge of and compliance with global policies and procedures, and compliance guidelines with respect to data dissemination and interactions with external HCPs
• Understand and actively address the unsolicited scientific information needs of external HCPs according to the guidelines above
• Support medical information associates in preparation and review of medical letters and other medical information materials
• Prepare and/or review scientific information in response to customer questions or media requests
• Support data analysis and the development of slide sets and publications (abstracts, posters, manuscripts)
• 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
• 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
• Be aware of current trends and projections for clinical practice and access
• May provide direct supervision to assigned clinical research physicians, clinical research scientists, and an administrative assistant
• 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
• Actively set and meet individual professional development goals and contribute to the development of others by being an active source of coaching and feedback
• Actively participate in recruitment, diversity, and retention efforts
• Model the leadership behaviors of and be an ambassador for the organisations brand

• Medical Doctor, Doctor of Osteopathy, Pharm Doctor or PhD degree with board eligibility or certification (preferred), or equivalent stature if non-US trained
• 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)
• 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
• Knowledge of medical affairs required, and substantial experience preferred with the brand
• Knowledge of drug development process required
• Experience desirable in health policy, health outcomes, statistics, payers, and/or healthcare organizations
• Excellent track record in personal engagement with thought leaders
• Strong ethics, patient-focus, and ability to earn credibility and trust
• Fluent in English, both written and verbal communications
• Interpersonal, organizational, and negotiation skills
• Excellent teamwork skills, including working with those from different background