Vice-President Clinical Affairs
About The Position
Senior leader responsible for defining and executing the clinical and evidence-generation strategy across the product portfolio. Leads a multidisciplinary organization that includes Evidence Generation Strategy, Clinical Research, Clinical Operations, Clinical Evaluation, Biostatistics & Data Science, and Pre Clinical teams. Partners with Regulatory, Quality, Medical Affairs, Commercial, and Product Development to deliver high-quality clinical evidence that supports regulatory submissions, health technology assessment (HTA), reimbursement, and optimal patient outcomes. Set clinical strategy and evidence-generation plans that align with business objectives, product strategy, regulatory requirements, and payer needs across development lifecycle (pre-clinical → clinical → post-market). Lead and grow an integrated, high-performing clinical organization covering clinical research, operations, clinical evaluation/medical writing, biostatistics, data science, and pre-clinical functions. Oversee design, execution, and delivery of clinical studies (first-in-human, pivotal, registries, observational/RWE, post-market surveillance), ensuring scientific rigor, ethical conduct, regulatory compliance, and on-time delivery. Provide scientific and operational leadership for statistical planning, data analysis, data management, and modern analytics (including AI/ML where applicable) to produce robust, reproducible evidence. Support relationships with external stakeholders: regulatory agencies, key opinion leaders, global investigators/sites, Contract Research Organizations (CROs), academic partners, and HTA bodies. Coordinate clinical input for regulatory submissions (IDE, PMA/510(k)/CE/other regional filings) and ensure clinical content for technical documentation and labeling is accurate and defensible. Ensure clinical quality systems and GCP-compliant processes are in place; champion risk-based monitoring, data integrity, safety reporting, and audit readiness. Partner with Medical Affairs and Commercial to translate clinical evidence into value communication for clinicians, payers, and customers; support publication and scientific communications strategy. Manage budgets, resource allocation, vendor selection and oversight, and program timelines across multiple portfolios. Develop talent through hiring, coaching, performance management, succession planning, and promoting cross-functional collaboration. Track key performance indicators (enrollment rates, milestones, data quality metrics, timelines, budget adherence, regulatory outcomes) and report progress to executive leadership and the Board as required. Accelerate speed to value and optimize resource utilization according to business objectives.
Requirements
- Advanced degree (MS, MD, PhD, PharmD, or equivalent).
- 12+ years of progressive experience in clinical development, clinical operations, biostatistics/data science, or related areas.
- At least 6 years in senior leadership roles.
- Demonstrated experience leading multidisciplinary teams and managing complex global c-programs, including pivotal trials and post-market studies.
- Strong knowledge of clinical trial design, biostatistics, clinical evaluation reports, pre-clinical to clinical translation, and real-world evidence generation.
- Experience interacting with regulatory authorities (e.g., FDA, EMA) and supporting regulatory filings and inspections.
- Proven vendor/CRO management experience and ability to oversee multiple outsourced relationships.
- Track record of successfully delivering programs on time and on budget, with measurable regulatory/market outcomes.
- Excellent communication and influencing skills; comfortable presenting to executive leadership and external stakeholders.
- Strong business acumen, strategic thinking, and ability to balance scientific rigor with commercial and regulatory needs.
- Global travel typically 20–40% depending on pipeline activities and external meetings.
Nice To Haves
- Experience in the relevant therapeutic area(s) or product modality (medical devices, combination products, or biologics).
- MBA or other business degree is a plus.
- Familiarity with health economics/HTA evidence requirements, payer evidence generation, and value dossiers.
- Practical knowledge of modern clinical trial approaches: adaptive designs, decentralized trials, digital endpoints, registries, synthetic controls, and RWE methodologies.
- Hands-on exposure to statistical programming environments and data science workflows; appreciation of data governance and reproducible research principles.
- Prior experience with global regulatory submissions (PMA/CE/IDE/510k) and post-approval study commitments.
Responsibilities
- Define and execute the clinical and evidence-generation strategy across the product portfolio.
- Lead a multidisciplinary organization including Evidence Generation Strategy, Clinical Research, Clinical Operations, Clinical Evaluation, Biostatistics & Data Science, and Pre Clinical teams.
- Partner with Regulatory, Quality, Medical Affairs, Commercial, and Product Development to deliver high-quality clinical evidence.
- Set clinical strategy and evidence-generation plans aligned with business objectives, product strategy, regulatory requirements, and payer needs.
- Lead and grow an integrated, high-performing clinical organization.
- Oversee design, execution, and delivery of clinical studies, ensuring scientific rigor, ethical conduct, regulatory compliance, and on-time delivery.
- Provide scientific and operational leadership for statistical planning, data analysis, data management, and modern analytics.
- Support relationships with external stakeholders: regulatory agencies, key opinion leaders, global investigators/sites, CROs, academic partners, and HTA bodies.
- Coordinate clinical input for regulatory submissions and ensure clinical content for technical documentation and labeling is accurate and defensible.
- Ensure clinical quality systems and GCP-compliant processes are in place.
- Partner with Medical Affairs and Commercial to translate clinical evidence into value communication.
- Manage budgets, resource allocation, vendor selection and oversight, and program timelines.
- Develop talent through hiring, coaching, performance management, succession planning, and promoting cross-functional collaboration.
- Track key performance indicators and report progress to executive leadership and the Board.
Benefits
- Annual performance bonus
- Consolidated retirement plan (pension)
- Savings plan (401(k))
- Long-term incentive program
- Vacation – 120 hours per calendar year
- Sick time - 40 hours per calendar year (varies by state)
- Holiday pay, including Floating Holidays – 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Executive
