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