US Medical Affairs Lead, Neisseria

Role Summary

US Medical Affairs Lead, Neisseria. Lead the development and execution of the US medical affairs strategy for the Neisseria portfolio and support growth of the portfolio. Reports 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 across the Neisseria vaccines‚Äô lifecycle, 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.
• Understand patient and physician interactions, clinical decision making and emerging trends in US healthcare landscape.
• Ensure the integration of US Medical insights and patient needs into a cross-functional strategy (IBCT).
• 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 oversee sign-off for all asset indications.
• Lead the design and delivery of Phase IIIB/IV studies (US Pharma funded) and drive the data generation strategy for HEOR/RWE 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.
• Provide input to study design and support local US/Canada study conduct activities for sponsored studies (Phase I‚ÄìIV).

Qualifications

• Must have Medical Doctor, PharmD, or PhD in life sciences with specialization in vaccinology, immunology, infectious diseases, microbiology, virology, life sciences, public health, pediatrics or health economics policy.
• 5+ years of industry and/or clinical experience in medical affairs or related fields.
• Experience working effectively in large enterprise matrix teams.
• Project management and leadership experience; ability to network and influence in a complex matrix environment.

Preferred Qualifications

• Clear understanding of the US healthcare environment and external stakeholders.
• Understanding of medical affairs accountabilities for strategic direction, evidence generation, external engagement, and internal advisory activities.
• Disease-area expertise and appropriate medical/clinical experience.
• Strong analytical skills to assess and interpret scientific data.
• Drug development experience across early development to life cycle management with knowledge of GCP, regulatory, market access and reimbursement requirements; understanding of promotional codes/regulations.
• Ability to engage 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.

Education

• Medical Doctor, PharmD, or PhD in life sciences (as above).