Description

Who We Are

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.

About Worldwide Research and Development

From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases.

The Role

• Strategic Leadership: Lead the development and execution of the Enzyme Therapies BU pipeline strategy, encompassing both lifecycle management of marketed products and development of future drug assets. Ensure all activities reflect corporate goals and deliver maximum portfolio value.
• Pipeline Optimization: Oversee strategic selection and prioritization of assets, balancing risk, investment, and return to optimize the BU pipeline and achieve or exceed Long Range Plan (LRP) goals for revenue and growth.
• Cross-Functional Team Leadership: Build and lead a high-performing, cross-functional development strategy team, including clinicians and asset team leaders. Foster a culture of excellence, collaboration, and continuous improvement.
• Enterprise & Stakeholder Alignment: Partner with clinical, regulatory, commercial, medical, portfolio strategy, and business development functions to align asset prioritization, planning, and execution with near-, mid-, and long-term revenue and growth ambitions.
• Lifecycle Management: Drive late-stage clinical development, study design, and execution for pivotal and post-marketing studies. Oversee lifecycle management of BU assets, including marketed products and new acquisitions.
• Business Development & External Innovation: Work closely with business development to evaluate and integrate external innovation opportunities, including asset acquisitions. Represent the BU in due diligence and asset prioritization discussions.
• Regulatory Leadership: Provide scientific and medical leadership for global regulatory filings and interactions, ensuring successful approval and maintenance of product licenses and dossiers.
• Communication & Integration: Serve as the primary communication liaison between the BU Leadership Team and R&D Leadership Team, ensuring functional strategy, portfolio priorities, and execution are clearly understood and integrated across the enterprise.
• Governance & Delivery: Ensure key BU portfolio deliverables are planned, executed, and measured through Asset Teams and associated partner teams. Support integration and decision-making through enterprise governance forums.
• External Relationships: Maintain strong relationships with investigators, regulators, key opinion leaders, and other external stakeholders to advance BU development goals.

Candidate Profile

• M.D. or M.D./PhD degree with 15+ years of clinical research and development experience within pharmaceutical/biotech industry, including 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.
• Therapeutic area experience in endocrinology, Gastroenterology, rheumatology, pulmonology, pediatric genetics, or related fields is preferred.
• Strong business orientation; adept at interfacing with commercial, business development, and cross-functional stakeholders.
• Excellent track record in building and growing high-performing teams, including the mentorship and development of physician talent.
• 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; as well as the ability to perform effectively in an adaptive environment.
• Ability to lead directly and by influence, including 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 (e.g., clinical trial protocols, Investigator’s Brochures, clinical study reports, integrated summaries of safety (ISS), integrated summaries of effectiveness (ISE), risk management plans (RMP), other regulatory documents including maintenance of product licenses, registration dossiers, value dossiers, pharmaco-economic dossiers).

• The ability to create and articulate an inspiring vision for the organization, not only for the areas they are directly responsible for, but the enterprise as a whole.
• The inclination to seek and analyze data from a variety of sources to support decisions and to align others with the organization's overall strategy.
• An entrepreneurial and creative approach to developing new, innovative ideas that will stretch the organization and push the boundaries within the industry.
• The ability to effectively balance the desire/need for broad change with an understanding of how much change the organization is capable of handling, to create realistic goals and implementation plans that are achievable and successful.

• The ability to set clear and challenging goals while committing the organization to improved performance; tenacious and accountable in driving results.
• Comfortable with ambiguity and uncertainty; the ability to adapt nimbly and lead others through complex situations.
• A risk-taker who seeks data and input from others to foresee possible threats or unintended circumstances from decisions; someone who takes smart risks.
• A leader who is viewed by others as having a high degree of integrity and forethought in their approach to making decisions; the ability to act in a transparent and consistent manner while always taking into account what is best for the organization.

• The ability to attract and recruit top talent, motivate the team, delegate effectively, celebrate diversity within the team, and manage performance; widely viewed as a strong developer of others.
• The ability to persevere in the face of challenges, and exhibit a steadfast resolve and relentless commitment to higher standards, which commands respect from followers.
• A leader who is self-reflective and aware of their own limitations; leads by example and drives the organization's performance with an attitude of continuous improvement by being open to feedback and self-improvement.

• Naturally connects and builds strong relationships with others, demonstrating strong emotional intelligence and an ability to communicate clearly and persuasively.
• An ability to inspire trust and followership in others through compelling influence, powerful charisma, passion in their beliefs, and active drive.
• Encourages others to share the spotlight and visibly celebrates and supports the success of the team.
• Creates a sense of purpose/meaning for the team that generates followership beyond their own personality and engages others to the greater purpose for the organization as a whole.

• Firmly believes that both sustainability and profit are in the organization’s best long-term interest.
• Integrates economic, societal, and environmental factors into a purpose-driven strategy, turning sustainability into a competitive advantage.
• Understands and incorporates viewpoints from all key stakeholders to drive decision making and share the benefits.
• Delivers breakthrough innovations and business models that create value for all stakeholders, continually challenging traditional approaches.
• Sets audacious business and sustainability goals, driving concerted action and investments, and stays the course in the face of setbacks or push-back from short-term oriented stakeholders.

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.