Website HengRui USA
HengRui USA is the US hub for our parent company Jiangsu Hengrui Medicine (600276 SHA), a global pharmaceutical company with around $90 Billion market value, $3.6 Billion annual revenue (data by 2019) and over 30,000 employees globally. The product line includes antineoplastic drugs, angiomyocardiac drugs, surgical drugs, contrast agents and antibiotics. The pipeline across different therapeutic areas such as oncology, autoimmune, pain management, metabolics etc.
In HengRui USA, we recognize, appreciate, and reward our team’s contributions; we emphasize our people’s well-being. We want you to feel empowered to do your best work, in a place where you are respected, engaged, fulfilled, and developing!
Vice President, Medical Affairs
Reports to (Title): Head of Development, Division 2
Department: Medical Affairs
Job Summary: The incumbent will be responsible for providing medical leadership to build a best in class Medical Affairs organization, and to develop and implement the global medical scientific strategic plan for assets of Hengrui division 2 in NA&Europe (including 505b2, generics and new drugs) by integrating insights from HCPs, patients and the health care landscape into the asset profile in alignment with the global medical accountabilities. The incumbent and the medical affairs team will be responsible for working with key stakeholders to develop and execute the medical affairs plan, including product launch strategies, life cycle management, post-marketing research, medical education, research grants, medical advisory boards, and scientific communication/publication components of the overall medical operating plan. The incumbent will provide strategic development, planning, implementation and oversight of Phase IV clinical trial programs within the Medical Affairs department in the therapeutic area.
The incumbent and their team will utilize expert medical/scientific knowledge to provide strategic input for the development of product strategies, business and development growth opportunities, and liaise with external stakeholders to solicit feedback and strengthen Hengrui’s medical reputation in the disease state community.
Additionally, the incumbent and their team will be responsible for review and approval of medical and scientific content of all relevant materials/communications including promotional content and other documents as appropriate and required.
Essential Job Functions:
- Develop and Lead Medical Affairs Strategic Plans: The medical affairs team will work with key stakeholders, management, and functional area leads to develop strategic and aligned Division II Medical Affairs Plans and will be expected to communicate and represent these plans to upper management/senior leadership. This includes responsibility for continuously updating plans and informing stakeholders of progress.
- Provide oversight and leadership of Phase IV clinical studies: The medical affairs team will direct and design strategies, planning and implementation of Phase IV clinical development programs. Provide medical oversight for protocol development, interpretation of trial results, final study report conclusions and publications. Serve as study director for trials. Provide critical medical input into the lifecycle management strategies in responsible therapeutic areas.
- Medical/Scientific subject matter expert: Serve as medical leader and subject matter expert providing direction for assigned products including (but not limited to) CRC, scientific communications, publication planning/review, advisory boards, health outcomes plans, MSL activities, speaker programs, investigator-initiated research and CME grant reviews or other internal key business processes. Other responsibilities include approval of medical and scientific content of Regulatory, Safety, Scientific Affairs, Medical Affairs and Commercial outputs for assigned therapeutic areas.
- External leadership: Provide leadership and strategic direction to stakeholders in interactions and communications with external customers, thought leaders, strategic alliances, key organizations, and institutions. Maintain external orientation by participating actively in external events and activities. Strengthen Hengrui’s medical reputation through successful management of medical dimensions of products.
- Contribute to continuous improvement and development of Medical Research function through leadership of functional initiatives
HCP Engagement Management
- Support the Therapeutic Area Project Champions through the Advisory Board/Round Table/Steering Committee process of materials through Healthcare Compliance (HCC) and Legal
- Assist in the execution of Health Care Practitioner (HCP) engagements by creating a project plan in conjunction with project champions, continue persistent follow-ups to drive high quality results
- Align with HCC, Project Champion, and Medical Affairs Operations team on consultant and vendor related activities:
- Fair Market Value (FMV)Process/Tiering/alignment with 3rd party vendors
- In addition to FMV procedures, the coordinator will assist Therapeutic Area Project Champions with Needs Assessment Form completion and non-scientific aspects of advisory boards (agendas, invitation lists, routing materials with the vendor, scheduling status calls, etc)
- Monitor annual ad board planning, and lead the guidance, and compliance within the archive system
- Lead and support versightof GMA/USMA ad boards, ensure required approvals and documentation are maintained
- Participate in the development of planning tools, templates, processes to support Medical Affairs
- Partner with Head, Global Medical Affairs Strategic Planning, Medical Capabilities and IT to evaluate hardware and software packages for Global and Regional Medical Affairs
- Lead and support the use of Veeva Vault for Therapeutic Area Listening Priority reporting and further report development
- Open Data Question (ODQ) development with Therapeutic Areas, ensure approvals through governance, legal leading
- Lead/support Medical Affairs special projects as required
Experience / Education
- MD or PhD with 12-15 + years of leadership experience in industry, acquired through global or regional/Local Medical Affairs or non-Medical Affairs relevant functional areas: e.g. Medical Science Liaison, regulatory affairs, clinical, epidemiology/PV, market access, discovery etc.
- Board Certification in a related field and relevant association memberships (e.g., AHA, ACC, ASCO, ASH, DIA) preferred
- Experience in drug development across early development, launch and life cycle management & GCP regulatory/ market access & reimbursement requirements & promotional codes/regulations.
Knowledge / Skills / Abilities:
- Clinical research experience, including conducting clinical trials in the Phase III b-IV area.
- Experience reviewing promotional materials from a medical perspective, publications planning.
- Experience working with cross functional medical and commercial teams.
- Deep knowledge of all pharmaceutical Medical Affairs activities
- Extensive knowledge of Marketing concepts/strategies
- Strong understanding of the pharmaceutical marketplace
- Well versed in FDA regulations/ICH guidelines regarding conduct of clinical studies in relevant therapeutic area
- Full knowledge and understanding of regulatory guidance regarding marketing/sales promotional materials
- Strong overall written and verbal communication skills
- Must have requisite skills to function in a complex and dynamic environment, including flexibility and ability to negotiate.
- ICMJE guidance/general publication practices
- Current ACCME guidelines
- Sound computer skills including Microsoft Word, and PowerPoint
- Familiarity with statistical methodology
- Ability to travel up to 25% as needed
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.