1mo ago

Senior Medical Director, Clinical Science

HealthcarePhysician

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Quick Summary

Overview

Who We AreBioMarin is a leading rare disease biotechnology company focused on genetically defined conditions. Guided by our purpose to develop medicines that make a profound impact on people’s lives,

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HealthcarePhysician

Responsibilities

~4 min read

→Clinical Strategy and Leadership

* Own the clinical development strategy for one or more assets (asset-level rather than study-level accountability), developing Clinical Development Plans (CDPs) aligned with overall product strategy and corporate objectives.
* Serve as clinical development team leader (CDTL) for assigned programs through registration and lifecycle management.
* Drive clinical strategy discussions with senior management and participate in Program Review Committee and Development Governance, making recommendations at key decision points that incorporate safety, efficacy, and benefit-risk considerations.
* Identify opportunities to accelerate timelines, optimize study designs, and mitigate program risks, ensuring alignment with the evolving scientific, medical, regulatory, and commercial landscape.
→Regulatory Leadership

* Lead the development of regulatory strategy in partnership with Regulatory Affairs and represent Clinical Science in interactions with global health authorities (e.g., FDA, EMA, PMDA).
* Lead preparation for and participation in key regulatory milestone meetings, including End-of-Phase 2, Breakthrough Therapy, Accelerated Approval pathway discussions, and BLA/NDA/MAA preparation.
* Lead authoring and review of major regulatory documents, including CDPs, Investigator Brochures, Briefing Books, Pediatric Investigation Plans, IND Annual Reports, Clinical Study Reports, Integrated Summaries, and marketing application submissions.
* Provide strategic scientific input into responses to regulatory questions and commitments, and support inspection readiness and GCP compliance.
→Clinical Development Execution

* Lead the scientific rationale for protocols, endpoints, and statistical approaches, partnering with Biometrics on analysis plans that support regulatory objectives.
* Provide strategic oversight of clinical study execution and guide study teams in resolving complex scientific, operational, and medical challenges.
* Serve as Medical Monitor on selected studies, as appropriate.
* Lead interactions with Data Monitoring Committees, Safety Review Committees, and external expert panels.
→Data Interpretation and Safety

* Lead review and interpretation of efficacy, safety, biomarker, and exploratory data to inform critical program decisions, and run data review meetings with scientific recommendations to development teams and senior leadership.
* Oversee safety signal evaluation and partner closely with Pharmacovigilance on risk assessment and benefit-risk evaluation.
* Present clinical findings and strategic recommendations to executive leadership and governance committees.
→Scientific Leadership and External Engagement

* Maintain deep expertise in disease biology, treatment landscape, and emerging science, serving as the clinical and scientific leader for the assigned therapeutic area.
* Build and sustain relationships with global thought leaders, investigators, professional societies, and patient advocacy organizations.
* Drive publication strategy, scientific communications, advisory boards, and congress activities in support of development programs.
→Portfolio, Talent, and Organizational Development

*Provide dematrixed mentorship to Clinical Scientists, Associate Medical Directors, and Medical Directors.
* Contribute to capability planning, recruitment, training, and retention strategies for Clinical Science.
* Contribute to departmental process improvement and the evolution of SOPs, decision frameworks, and best practices.
* Foster a culture of scientific excellence, accountability, collaboration, and patient focus.
→Business Development Support

* Serve as a clinical expert supporting new project identification, including internal pipeline opportunities and external business development assessments.

Qualifications

* MD or MD/PhD (or international equivalent) required; board certification or specialty training preferred.
* Typically 10+ years of experience in biotechnology, pharmaceutical development, academic medicine, or related fields.
* Significant experience leading clinical programs across multiple phases, including registrational studies.
* Demonstrated experience interacting with global regulatory authorities and contributing to major submissions.
* Experience in rare genetic, metabolic, or orphan disease development strongly preferred; experience with gene therapy or enzyme replacement therapy is a plus.
* Prior experience as Medical Monitor and leading cross-functional development teams.
* Strong scientific writing, executive communication, and stakeholder influence skills.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.