US Medical Affairs Lead, Neisseria

Role Summary

US Medical Affairs Lead, you will play a key strategic role in the development and execution of the US medical affairs strategy and support continued growth of GSK’s Neisseria portfolio. This role will report to the Head, Pediatric, Adolescent & Pipeline Vaccines Portfolio.

Responsibilities

• Being accountable for overall medical strategy, development of the medical plan and achievement of the tactical objectives of the Neisseria portfolio.
• Responsible for ensuring strategic alignment and collaboration with Commercial, Global Medical, and cross functional partners to build understanding of US landscape, market value drivers, unmet medical needs and clear communication on timelines required for success.
• Representing US medical in cross-functional strategy meetings and workshops, proactively offering options for medical strategy and innovative activities.
• As a core member of the Global Medical Team (GMT), jointly accountable for developing the global medical strategy, co-developing the global medical strategy throughout the Neisseria vaccines‚Äô lifecycle by integrating the US medical environment and voice of the customer.
• Accountable for the Global Integrated Medical Communication Plan (IMCP) and scientific narrative.
• Support the definition of data gaps and development of a data generation strategy by ensuring US data needs are incorporated; responsible for US input at key inflection points during development.
• Serve as the internal expert on the management of the Neisseria portfolio and maintain deep product, prevention landscape and disease expertise; ensure integration of US Medical insights into cross-functional strategy.
• In collaboration with Medical Directors and Field Medical, lead/contribute to appropriate US scientific engagement between GSK and external communities to advance scientific and medical understanding.
• Lead the Medical Matrix Team and co-lead the cross-functional IBCT to tailor/adapt medical strategy for specific customer needs and US environment.
• Responsible for launch and product development including US data and content needs for the portfolio, including the indication expansion strategy in market.
• Coordinate with the US MSL and Field Policy and Payor teams to ensure alignment and effective engagement with top US-based external experts, policy and payer decision makers.
• Accountable for measuring and investing in medical activities that drive the greatest impact in improving patient care.
• Manage a team of medical directors supporting the Neisseria vaccines portfolio.
• Accountable for overall budget of Neisseria vaccines portfolio in the US; apply medical governance for all activities and sign off for all asset indications.
• Lead the design and delivery of Phase IIIB/IV studies (US Pharma funded) and drive data generation strategy for HEOR/RWE in collaboration with US HEOR and global teams.
• Work closely with safety, regulatory, and manufacturing to ensure best benefit-risk assessment and quick integration of relevant changes.
• Serve as US medical affairs point for all safety issues for Neisseria vaccines.
• For vaccines sponsored studies (Phase I‚ÄìIV), provide input to study design and support local US/Canada study conduct activities required before study start, during the study and after study completion and analysis.

Qualifications

• Medical Doctor, PharmD, PhD in life sciences. Specialization in vaccinology, immunology, infectious diseases, microbiology, virology, life sciences, public health, pediatrics or health economic policy.
• 5+ years industry and/or clinical experience in the relevant field, acquired through Medical Affairs or related areas (regulatory affairs, clinical development, public health, epidemiology, market access, discovery, etc.).
• Experience working effectively in large enterprise matrix teams; project management and leadership experience; ability to network and influence in a complex matrix environment.
• Must be able to clearly demonstrate a thorough understanding of the US healthcare environment including external stakeholders; understanding of medical affairs accountabilities for setting strategic direction, evidence generation, external engagement, and internal advisory roles; direct experience preferred.
• Demonstrated disease area expertise and appropriate medical/clinical experience; strong analytical skills to assess and interpret scientific data.
• Drug development experience across early development, launch and lifecycle management with knowledge of GCP, regulatory, market access and reimbursement requirements; understanding of promotional codes/regulations.
• Demonstrated ability to engage, build, and sustain a broad external expert network; excellent written and verbal communication and presentation skills; experienced speaker on scientific/medical topics.
• Willingness to travel up to 20% of working time.

Skills

• Strategic medical planning
• Cross-functional collaboration
• Data generation strategy and HEOR/RWE
• Medical governance and sign-off
• Clinical study design input (Phase I‚ÄìIV)
• Stakeholder engagement and external affairs