VP, Enzyme Therapies Business Unit, Clinical Science
BioMarin Pharmaceutical Inc.
5 months ago
Remote friendly (San Rafael, CA)
United States
Clinical Research and Development
The Vice President, Enzyme Therapies, Clinical Development is the head of R&D for BioMarin’s Enzyme Therapies Business Unit (BU), responsible for overall strategic direction, development, and lifecycle management of BU pipeline assets.
Key responsibilities:
- Strategic leadership: Develop and execute the Enzyme Therapies BU pipeline strategy, including lifecycle management of marketed products and development of future drug assets.
- Pipeline optimization: Select and prioritize assets, balancing risk, investment, and return; achieve or exceed Long Range Plan (LRP) revenue and growth goals.
- Cross-functional team leadership: Build and lead a high-performing cross-functional development strategy team (including clinicians and asset team leaders).
- Enterprise & stakeholder alignment: Partner with clinical, regulatory, commercial, medical, portfolio strategy, and business development to align prioritization, planning, and execution with near-, mid-, and long-term growth ambitions.
- Lifecycle management: Drive late-stage clinical development (pivotal and post-marketing), study design, and execution; manage BU assets including marketed products and new acquisitions.
- Business development & external innovation: Evaluate/integrate external innovation opportunities (including acquisitions); represent BU in due diligence and asset prioritization.
- Regulatory leadership: Provide scientific and medical leadership for global regulatory filings and interactions; support approval and maintenance of product licenses and dossiers.
- Communication & integration: Serve as liaison between BU and R&D leadership; ensure integrated strategy and execution across the enterprise.
- Governance & delivery: Ensure BU portfolio deliverables are planned, executed, and measured via Asset Teams and partner teams; support governance and decision-making.
- External relationships: Maintain relationships with investigators, regulators, key opinion leaders, and other stakeholders.
Qualifications (required):
- M.D. or M.D./PhD with 15+ years of clinical R&D experience in pharma/biotech, including 8+ years in a leadership role managing teams.
- Significant experience in late-stage clinical development in biopharma.
- Demonstrated leadership of successful global regulatory filings (NDA/BLA/MAA).
- Oversight of clinical development of a therapeutic area or multiple assets within a disease area.
Qualifications (preferred):
- Therapeutic area experience in endocrinology, gastroenterology, rheumatology, pulmonology, pediatric genetics, or related fields.
Skills/competencies:
- Business orientation; interface effectively with commercial, business development, and cross-functional stakeholders.
- Proven success building and growing high-performing teams; mentorship/development of physician talent.
- Strong leadership, organizational, written/verbal communication, and interpersonal skills.
- Ability to influence diverse internal/external stakeholders.
- Strategic and critical thinking; adaptive leadership.
- Direct leadership and influence; problem-solving, conflict resolution, analytical skills.
- Ability to facilitate complex discussions and drive decisions.
- Proven creation of high-quality clinical/regulatory documentation (e.g., protocols, investigator’s brochures, study reports, ISS/ISE, RMP, and regulatory dossiers/licenses/value/pharmaco-economic documents).
Key responsibilities:
- Strategic leadership: Develop and execute the Enzyme Therapies BU pipeline strategy, including lifecycle management of marketed products and development of future drug assets.
- Pipeline optimization: Select and prioritize assets, balancing risk, investment, and return; achieve or exceed Long Range Plan (LRP) revenue and growth goals.
- Cross-functional team leadership: Build and lead a high-performing cross-functional development strategy team (including clinicians and asset team leaders).
- Enterprise & stakeholder alignment: Partner with clinical, regulatory, commercial, medical, portfolio strategy, and business development to align prioritization, planning, and execution with near-, mid-, and long-term growth ambitions.
- Lifecycle management: Drive late-stage clinical development (pivotal and post-marketing), study design, and execution; manage BU assets including marketed products and new acquisitions.
- Business development & external innovation: Evaluate/integrate external innovation opportunities (including acquisitions); represent BU in due diligence and asset prioritization.
- Regulatory leadership: Provide scientific and medical leadership for global regulatory filings and interactions; support approval and maintenance of product licenses and dossiers.
- Communication & integration: Serve as liaison between BU and R&D leadership; ensure integrated strategy and execution across the enterprise.
- Governance & delivery: Ensure BU portfolio deliverables are planned, executed, and measured via Asset Teams and partner teams; support governance and decision-making.
- External relationships: Maintain relationships with investigators, regulators, key opinion leaders, and other stakeholders.
Qualifications (required):
- M.D. or M.D./PhD with 15+ years of clinical R&D experience in pharma/biotech, including 8+ years in a leadership role managing teams.
- Significant experience in late-stage clinical development in biopharma.
- Demonstrated leadership of successful global regulatory filings (NDA/BLA/MAA).
- Oversight of clinical development of a therapeutic area or multiple assets within a disease area.
Qualifications (preferred):
- Therapeutic area experience in endocrinology, gastroenterology, rheumatology, pulmonology, pediatric genetics, or related fields.
Skills/competencies:
- Business orientation; interface effectively with commercial, business development, and cross-functional stakeholders.
- Proven success building and growing high-performing teams; mentorship/development of physician talent.
- Strong leadership, organizational, written/verbal communication, and interpersonal skills.
- Ability to influence diverse internal/external stakeholders.
- Strategic and critical thinking; adaptive leadership.
- Direct leadership and influence; problem-solving, conflict resolution, analytical skills.
- Ability to facilitate complex discussions and drive decisions.
- Proven creation of high-quality clinical/regulatory documentation (e.g., protocols, investigator’s brochures, study reports, ISS/ISE, RMP, and regulatory dossiers/licenses/value/pharmaco-economic documents).