About the Role:Provides senior leadership for enterprise-wide epidemiology and real-world evidence (RWE) strategy, governance, and execution across therapeutic areas and portfolios. Accountable for defining and delivering fit-for-purpose, consistent evidence strategies that support clinical development, regulatory submissions, medical affairs, and market access. Serves as a senior thought partner to R&D, Medical, Market Access, and Analytics leadership and leads teams responsible for high impact, externally facing epidemiologic and RWE programs.
Your Contributions (include, but are not limited to):- Define and lead enterprise-wide epidemiology and RWE strategy, ensuring alignment with corporate objectives and cross-functional priorities across R&D, Medical, Market Access, and Analytics.
- Establish and oversee functional governance, including methodological standards, evidence quality expectations, prioritization frameworks, and ways of working across therapeutic areas.
- Translate enterprise RWE strategy into portfolio- and therapeutic-area-level evidence plans supporting development, launch, and lifecycle management.
- Serve as a senior advisor to executive and cross-functional leadership on population health, disease epidemiology, and real-world evidence.
- Drive evidence strategies that directly support regulatory submissions, HTAs, reimbursement decisions, and global value demonstration.
- Lead, coach, and develop Directors, Managers, and senior scientific staff; ensure effective talent development and succession planning.
- Oversee functional resourcing and budget management to ensure efficient, compliant, and high-quality execution.
- Partner closely with R&D leadership to integrate RWE into Phase 3 trial design and late-stage development, including external control arms, endpoint validation, and contextualization of clinical outcomes.
- Provide functional scientific accountability for epidemiology and RWE components of late-stage development programs.
- Ensure rigorous epidemiologic and observational methodologies are applied consistently across programs.
- Collaborate with Drug Safety and Pharmacovigilance (DSPV) on epidemiologic analyses supporting background rates, safety surveillance, post-marketing commitments, and risk assessment.
- Provide strategic oversight and input into clinical plans, publications, and integrated evidence strategies.
- Partner with HEOR and Market Access leadership to generate fit-for-purpose RWE demonstrating clinical value, effectiveness, cost-effectiveness, and budget impact.
- Ensure RWE outputs meet global payer, HTA, and regulatory evidentiary expectations, anticipating evolving requirements.
- Serve as a primary functional representative in scientific advice meetings and evidence discussions with regulatory agencies and HTA bodies.
- Engage and influence external stakeholders including regulators, academic experts, data partners, industry consortia, and advisory boards.
- Represent the Epidemiology & RWE function in governance forums, internal and external scientific engagements.
- Oversee and ensure consistency, scientific integrity, and quality of all epidemiology and observational research programs.
- Contribute to regulatory submission planning, including data strategies, integrated summaries, and evidence positioning.
- Develop and maintain functional processes, SOPs, and compliance frameworks to support scalable and high-quality evidence generation.
- Serve as the escalation point for complex scientific, regulatory, or payer-facing evidence issues.
- Perform other duties as assigned.
Requirements:Typical Experience or Education:- Master's Degree AND 12+ years of relevant experience OR
- PhD, PharmD, or MD in Epidemiology, Public Health, or a related field AND 10+ years of pharmaceutical or biotech experience in epidemiology and/or real-world evidence. OR
- Previous management experience
Common Knowledge and Skills- Acts as a "trusted advisor" across the company and may be recognized as an external expert
- Provides strategy, vision and direction regarding issues that may have company-wide impact
- Requires in-depth knowledge of the functional area, business strategies, and the company's goals
- Must be self-motivated and detail-oriented
- Ability to quickly learn and think independently
- Excellent leadership, coaching and employee development skills
- Ability to effectively lead a team of statistical programmers with demonstrated proficiency in the hiring, training, and supervision of in-house and contract statistical programmers
- Excellent interpersonal & communication skills with the ability to interact professionally and effectively with peers, management, and leadership both within and outside the Company
- Ability to work with a team of individuals to meet organizational goals
- Possesses industry-leading knowledge pertaining to clinical and regulatory aspects of a pharmaceutical company.
- Evaluates key business / scientific challenges and completes complex, ambiguous initiatives having cross-functional impact
- Ability to apply advanced analytical thought and judgement
- Ability to work in a cross-functional team and a matrix environment
- Excellent organizational and time management skills with the ability to work independently and coordinate workload, under pressure, and in a team environment to meet established deadlines
- Excellent interpersonal skills and problem-solving capabilities
Job Specific Knowledge and Skills- Demonstrated leadership of enterprise-level evidence strategies, complex cross-functional programs, and people leaders.
- Deep understanding of regulatory, HTA, payer, and market access evidence requirements.
- Strong communication, influence, and stakeholder management skills.
The annual base salary we reasonably expect to pay is $230,100.00-$314,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 35% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.
