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). #J-18808-Ljbffr
Vp, Enzyme Therapies Business Unit, Clinical Science
SCORPION THERAPEUTICS
estado de méxico, estado de méxico
Publicado hace 7 días
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