Director or Sr. Director of Clinical Strategy and Medical Affairs (Onsite/Remote)

About the position

The Senior Director/Director of Clinical Strategy and Medical Affairs is a key leadership role responsible for developing and executing clinical strategies that drive regulatory approvals, commercial adoption, and reimbursement success. This individual will lead the development of clinical trial designs, oversee clinical data management, establish a robust publication strategy, drive medical affairs initiatives, and manage regional product labeling compliance standards (e.g., Instructions for Use [IFU], Important Safety Information [ISI], and regulatory labels). Additionally, this role will ensure compliance with industry regulations regarding industry-supported scientific and educational activities, ensuring that engagements with healthcare professionals (HCPs) and stakeholders remain scientific, balanced, and non-promotional. This position requires strong cross-functional leadership and collaboration with senior leadership, regulatory, clinical operations, quality, commercial, and market access teams to ensure clinical strategies align with business objectives.

Responsibilities

• Lead the design and development of EBR-sponsored pre-market (FIH, feasibility, pivotal) and post-market (post-approval studies, registries, real-world evidence) clinical trials.
• Ensure that study endpoints align with regulatory, reimbursement, and commercial goals to support product approval and market adoption.
• Responsible for developing clinical evidence strategies for label expansions, payer coverage decisions, and health technology assessments (HTAs) defined by EBR.
• Provide scientific and strategic input on protocol development, clinical investigation plans, statistical analysis plans (SAPs), and regulatory submissions.
• Collaborate with biostatistics, data management, and clinical operations teams to ensure high-quality clinical data generation and analysis.
• Establish and manage a medical affairs program within EBR.
• Develop and drive a publication and scientific communication strategy, including manuscripts, abstracts, and conference presentations.
• Serve as a scientific expert for interactions with regulatory agencies, payers, hospital decision-makers, and external stakeholders.
• Ensure all scientific and educational activities are independent and non-promotional and comply with FDA and AdvaMed guidelines.
• Develop internal and external scientific education programs for teams, clinical investigators, and HCPs.
• Develop and manage investigator-initiated study (IIS) programs and academic collaborations.
• Collaborate with Clinical Operations and consultants to draft and finalize Clinical Study Reports (CSRs), driving the analysis, discussion, and conclusion sections.
• Manage the development of Clinical Evaluation Reports (CERs) for international regulatory submissions (MDR and OUS registrations).
• Manage Investigator Brochures (IBs) development and maintenance to ensure alignment with clinical trial data, risk-benefit assessments, and global regulatory expectations.
• Oversee the development, review, and maintenance of regulatory labeling documents (marketing and medical education documents are not in scope), including: Instructions for Use (IFU), Important Safety Information (ISI), and Regulatory product labels.
• Ensure labeling updates align with new clinical data, risk-benefit evaluations, and regulatory labeling requirements.
• Collaborate with Regulatory Affairs and Quality teams to ensure compliance with FDA, MDR, and OUS regulatory labeling requirements.
• Manage external consultants used to draft CSRs and CERs.
• Provide scientific/clinical expertise to Quality Assurance (QA) and Regulatory teams for post-market surveillance (PMS) and safety monitoring activities.
• Support post-market clinical follow-up (PMCF) studies and real-world evidence (RWE) generation to ensure compliance with regulatory requirements.
• Contribute to scientific interpretation of post-market safety data, assessing clinical trends, risk-benefit profiles, and product performance.
• Support health economics and outcomes research (HEOR) strategies to support payer and hospital decision-making.
• Collaborate with the Senior Leadership Team to ensure that clinical strategy align with business objectives.
• Work closely with Regulatory Affairs, Clinical Operations, Market Access, and Commercial teams to ensure clinical data supports business objectives.
• Provide scientific leadership in global regulatory submissions (FDA, CE Mark, OUS approvals), ensuring clinical data meets regulatory requirements.
• Partner with commercial and reimbursement teams to develop clinical messaging for payers, hospitals, and healthcare providers.
• Stay ahead of competitive intelligence and market trends to inform clinical and regulatory strategy.

Requirements

• Bachelor’s degree in scientific, medical, or engineering field is required.
• Advanced degree in a scientific, medical, or clinical field (MD, PhD, PharmD, or MS with extensive experience in clinical research) is preferred.
• Prior experience in a clinical environment (e.g., Nurse Practitioner, Physician Assistant, Field Clinical Engineer, or Medical Doctor).
• Proven track record of publication strategy development, conference presentations, and medical education leadership.
• Minimum of 7 years of experience in medical affairs or related medical device, pharmaceutical, or biotech industry roles for Director level.
• Minimum of 10 years of experience in medical affairs or related roles in the medical device, pharmaceutical, or biotech industry for Senior Director level.
• Strong experience with investigation device exemption (IDE), premarket approval (PMA), global regulatory submissions, and post-market and real-world evidence studies.

Nice-to-haves

• Expertise in engaging KOLs, advisory boards, and clinical stakeholders to drive clinical adoption.
• Excellent leadership, strategic thinking, and stakeholder management skills.
• In-depth knowledge of FDA, EU MDR, ISO, QSR, and post-market surveillance requirements.
• Exceptional written and verbal communication skills, with the ability to influence senior stakeholders.
• Proficiency in MS Word, Excel, PowerPoint, Teams, and Adobe Pro.

Benefits

• Medical, dental, and vision insurance provided at no cost for employee-only coverage.
• 401(k) matching plan.
• Paid Time Off – starting at 3 weeks per year.
• Competitive salary with opportunities for career growth.
• Employee stock options.
• Life & AD&D and long term disability insurance.
• Education assistance.
• Voluntary commuter benefits and pet insurance.
• Weekly company lunches and occasional happy hour events.
• Meaningful work and much more!