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The Vice President, Enzyme Therapies, Clinical Development is the head of Research & Development for BioMarin’s Enzyme Therapies Business Unit (BU). This executive is responsible for the overall strategic direction, development, and lifecycle management of both current and future assets within the BU pipeline.
Job Responsibility:
Lead the development and execution of the Enzyme Therapies BU pipeline strategy
Oversee strategic selection and prioritization of assets
Build and lead a high-performing, cross-functional development strategy team
Partner with clinical, regulatory, commercial, medical, portfolio strategy, and business development functions
Drive late-stage clinical development, study design, and execution for pivotal and post-marketing studies
Work closely with business development to evaluate and integrate external innovation opportunities
Provide scientific and medical leadership for global regulatory filings and interactions
Serve as the primary communication liaison between the BU Leadership Team and R&D Leadership Team
Ensure key BU portfolio deliverables are planned, executed, and measured
Maintain strong relationships with investigators, regulators, key opinion leaders, and other external stakeholders
Requirements:
M.D. or M.D./PhD degree
15+ years of clinical research and development experience within pharmaceutical/biotech industry
8+ years in a leadership role leading and managing teams
Significant experience in late-stage clinical development within the biopharma industry
Demonstrated leadership of successful regulatory filings (NDA/BLA/MAA) for global clinical programs
Oversite of clinical development of a therapeutic area or multiple assets within a disease area
Excellent track record in building and growing high-performing teams
Excellent leadership and organizational skills, written and verbal communication skills, and interpersonal skills
Ability to effectively influence diverse internal and external customer groups at various levels
Demonstrated strategic and critical thinking, dynamic leadership, and team-building skills
Ability to perform effectively in an adaptive environment
Ability to lead directly and by influence
Strong problem-solving, conflict resolution, and analytical skills
Ability to facilitate discussions among groups with diverse technical expertise and varying opinions and drive decisions on complex issues
Proven success leading the creation of key clinical documentation with high quality and consistency
Nice to have:
Therapeutic area experience in endocrinology, Gastroenterology, rheumatology, pulmonology, pediatric genetics, or related fields
What we offer:
Discretionary annual bonus
Discretionary stock-based long-term incentives
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans