Sr. Director/Director of Clinical Strategy and Medical Affairs

Description

Job Summary: 

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. 

Essential Duties and Responsibilities include, but are not limited to the following:

Clinical Strategy & Trial Design

· 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.

Medical Affairs and Scientific Communications  

· 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.

Regulatory & Labeling Documentation

· 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.

Evidence Generation, Safety, & Post-Market Strategy

· 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.

Cross-Functional Leadership & Strategic Collaboration

· Collaborate with the Senior Leadership Team to ensure that clinical strategy align with business objectives.

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