Vice President, Medical Affairs - US

Mix Talent; Philadelphia (Philadelphia County); On-site; USD 300,000 - 460,000; Full time

Benefits offered by this job

Executive leadership role

Ground-floor build opportunity

Competitive compensation

Job summary

Mixtalent is seeking a VP of Medical Affairs – US to lead the development and execution of the medical strategy for current and future products. The role requires building the US Medical Affairs organization from the ground up, shaping processes, culture, and governance across Safety, Regulatory, R&D and Commercial teams.

The candidate will drive scientific engagement with HCPs, KOLs, and patient communities, supervise pharmacovigilance, and align medical activities with FDA requirements and

Qualifications

• MD degree required; specialist training or PhD strongly preferred.
• Demonstrated experience leading medical affairs strategy for pipeline and/or marketed products.
• Extensive experience with KOL engagement, field medical leadership, and scientific communication planning.

Responsibilities

• Develop and lead the US medical affairs strategy aligned with corporate and R&D objectives.
• Build and govern the US Medical Affairs organization and budget.
• Engage HCPs, KOLs and patient groups to inform development and lifecycle plans.
• Oversee pharmacovigilance and patient safety governance in US operations.
• Collaborate with Regulatory, Commercial, Market Access and R&D to ensure compliant, launch-ready medical strategies.

Skills

Cross-functional leadership

Executive communication

Strategic thinking

KOL engagement

Medical affairs leadership

Education

MD degree

PhD preferred

Job description

The VP of Medical Affairs – US, is the senior medical affairs leader responsible for building and executing the US medical strategy, accelerating portfolio growth and delivering medical affairs excellence across current and future products. The successful candidate will have extensive experience developing medical affairs strategy for a series of launches, with a strong understanding of the evolving CNS landscape and the scientific engagement needs of key stakeholders across the treatment continuum.

This is a ground-floor leadership opportunity: the VP will build the Medical Affairs team and infrastructure from scratch, shaping strategy, processes, and culture ahead of launch. This individual will work cross-functionally with the Science Organization, R&D, Regulatory Affairs, Commercial, Market Access, and Pharmacovigilance to ensure medical strategies are aligned, scientifically sound, and launch-ready.

The VP of Medical Affairs is a senior scientific and clinical leader responsible for shaping and executing the company’s medical affairs strategy to support current and future products. The role serves as the primary scientific interface with healthcare professionals (HCPs), key opinion leaders (KOLs), patient communities, and external scientific stakeholders.

In addition, the role provides executive oversight of pharmacovigilance and patient safety, ensuring robust safety governance, regulatory compliance, and integration of real-world safety insights into product development and lifecycle management.

The VP of Medical Affairs plays a critical role in defining future product development strategy by translating unmet medical needs, clinical practice insights, and patient perspectives into actionable R&D and clinical development priorities.

Major Duties and Responsibilities

1. Medical Affairs Strategy & Scientific Leadership

• Develop and lead the global medical affairs strategy aligned with corporate and R&D objectives.
• Act as the internal medical authority for pipeline and marketed products, ensuring scientific credibility and consistency.
• Provide strategic medical input into target product profiles (TPPs), promotional materials, clinical development plans, and lifecycle management.
• Ensure medical affairs activities are compliant and aligned with ethical and regulatory standards.

2. Healthcare Professional (HCP) & KOL Engagement

• Build and maintain strategic relationships with key opinion leaders, investigators, and clinical experts.
• Lead scientific exchange activities including advisory boards, key account meetings, and scientific congress engagement.
• Capture and synthesize insights from HCP interactions to inform clinical development, indication expansion, and differentiation strategies.
• Support publication planning and data dissemination.
• Establish structured engagement with patient advocacy groups and patient representatives.
• Integrate patient insights into development strategy, endpoint selection, and benefit–risk assessments.
• Ensure patient-focused drug development principles are embedded across programs.
• Support development of patient education and disease awareness initiatives.

4. Pharmacovigilance & Patient Safety Oversight

• Be responsible for the Pharmacovigilance safety governance framework.
• Ensure compliance with US PV regulations (e.g., ICH, FDA requirements).
• Review and interpret safety data, signal detection outputs, PSURs/PBRERs, and risk management plans (RMPs).
• Act as a senior safety decision-maker, contributing to benefit–risk evaluations and safety-related regulatory interactions.
• Ensure safety insights are fed back into clinical development, labeling, and risk minimization strategies.

5. Cross-Functional Leadership & Governance

• Serve as a core member of the US Leadership Team and contribute to overall US strategy, culture and operating performance.
• Build strong partnerships with Commercial, Market Access, R&D, Regulatory, Legal, Compliance, Finance, Operations, Supply Chain, Quality, IT and global colleagues.
• Champion a patient- and customer-centered mindset while balancing growth, compliance, reputation and long-term portfolio value.
• Create a culture of curiosity, speed, disciplined decision-making, constructive challenge and shared accountability for results.
• Develop internal talent and external partnerships that allow the organization to scale efficiently in a high-growth, resource-conscious environment.
• Recognize and celebrate individual and team contributions while addressing performance gaps directly and constructively.
• Serve as a core member of development governance committees (e.g., Safety Review Committee, Development Review Board).
• Serve as a core member of the Promotional & Medical Review Committee (PMRC)
• Collaborate closely with R&D, Regulatory Affairs, and Quality to ensure aligned external messaging and risk management.
• Support due diligence activities for in-licensing, acquisitions, and partnerships from a medical and safety perspective.
• Mentor and develop the pharmacovigilance teams, fostering a culture of scientific excellence and compliance.
• Create clear decision rights, governance and operating rhythms across strategy, long-range planning, content, execution, measurement and optimization.
• Communicate complex strategies and performance insights clearly to senior leaders and gain alignment on investment choices, trade-offs and corrective actions.
• Own the US medical affairs budget and deliver financial objectives through rigorous planning, prioritization, forecasting and ongoing optimization.
• Build transparent investment cases and track planned versus actual spend, commitments, expected return and realized impact.
• Ensure supplier governance, contracting, purchase-order discipline and adherence to delegation-of-authority requirements.
• Operate in full compliance with applicable US laws, regulations, company policies and industry standards, including FDA prescription drug promotion requirements, privacy and consent requirements, pharmacovigilance obligations and the PhRMA Code
• Strategic thinker with the ability to influence R&D direction through medical insight.
• High credibility with external scientific and clinical stakeholders.
• Strong cross-functional leadership and decision-making skills.
• Excellent communication skills, both scientific and executive-level.
• High ethical standards and commitment to patient safety.

Knowledge and Experience

• Medical degree (MD) required; specialist training or PhD strongly preferred.
• 10 years of experience in Medical Affairs, Clinical Development, or related functions within the pharmaceutical or biotechnology industry
• Demonstrated experience leading medical affairs strategy for pipeline and/or marketed products.
• Direct experience working with pharmacovigilance and safety governance frameworks.
• Extensive experience with KOL engagement, field medical (MSL) leadership, and scientific communication planning.
• Experience incorporating patient insights into development or lifecycle strategies.
• Extensive experience working collaboratively with Market Access to present to Key Strategic Accounts (e.g., GPOs, IDNs, PBMs, Payors, etc)
• Strong knowledge of FDA regulatory requirements as they relate to medical affairs activities, industry compliance standards (PhRMA Code, OIG guidance), and evidence generation/real-world data strategy.
• Excellent scientific, strategic, and executive communication skills.
• Proven ability to build a function and team from the ground up in a fast-paced environment.
• Experience leading cross-functional teams and managing external vendors/consultants