Integrated Evidence Team Lead, Skeletal Conditions (open in the UK too)

Location:  San Rafael, California Category: Medical Affairs

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 Integrated Evidence Team Lead for skeletal conditions will report to the Head of Medical Evidence Generation, Global Medical Affairs at Biomarin.  This is a newly created matrix team leadership role that will oversee the development and execution of integrated evidence plans and coordinate cross-functional evidence generation activities for Voxzogo including marketed and LCM indications.
KEY RESPONSIBILITIES 
  • Leading full lifecycle of integrated evidence team activities: 
Facilitate communication and alignment between different teams including clinical development, medical affairs, market access, health economics, patient-centered outcomes, regulatory, scientific communications, and commercial, to ensure multi-stakeholder evidence needs are identified and addressed in a unified Integrated Evidence Plan (IEP). Works closely with Global Medical Lead and Scientific Communications to ensure IEP pull-through linking evidence needs to desired message and product narrative. Prepare, review and present materials to BioMarin governance committees and leadership.
  • Leading the development and management of IEPs: 
Lead the development of Integrated Evidence Plan that represents a single source of truth on all evidence related activities for Voxzogo across functions and geographies. Plan and facilitate cross-functional IET meetings.  Coordinate activities to identify critical evidence gaps, critically assess study design options to address gaps, and incorporate into the evidence package. Ensure evidence plans are aligned with asset strategy and overall asset vision. Maintain the IEP on an ongoing basis, ensuring deliverables are on-track and reacting to changes to the external environment or internal strategy.
  • Contributing to improvement of integrated evidence process:
Partner with Integrate Evidence Excellence Lead to ensure IE framework, digital tool, process and best practice are utilized consistently. Provide insight to help improve the continual enhancement of IE process.
  • Ensuring evidence generation pull-through: 
Facilitate the maximal use of available evidence across cross-functional teams. Collaborate with Study Teams to ensure optimal pull-through and dissemination of evidence.
  • Strategic decision-making: 

Provide expert insights to leadership regarding evidence gaps, data interpretation, and potential risks/opportunities to inform product strategy and decision-making. Lead tradeoff and valuation exercises in collaboration with Integrated Evidence Excellence Lead and Finance representative to develop the quantitative and qualitative model to rationalize options of evidence generation tactics.
DESIRED EXPERIENCE 
  • PharmD/PhD/MD in life sciences with minimum 10+ years of related experience in the biotech/pharmaceutical industry, preferably within Rare Disease.
  • Minimal 6 years hands-on experience leading cross-functional Integrated Evidence Teams or other evidence generation or study operations teams in global settings.
  • Deep understanding of drug development process and commercialization, including evidence needs for value access and patient outcome.
  • Expertise in designing, delivering and leading evidence generation activities including interventional and observational studies.
  • Ability to seek and analyze data and insights from a variety of sources to create an aligned strategy.
 
TECHNICAL COMPETENCY
  • Proven ability to effectively influence without direct authority, building trust and motivating teams by providing vision and clear communication on expectations to achieve meaningful outcomes and create business impact.
  • Holds team members accountable for deliverables by creating a shared sense of ownership for success; encourages risk identification and mitigation strategies.
  • Excellent communication and collaboration abilities to work effectively with cross-functional teams.
  • Analytical skills to interpret data and generate actionable insights 
  • Comfortable with ambiguity and uncertainty; the ability to adapt nimbly and lead others through complex situations.
  • Excellent project management skills, attention to details, and execution of impactful presentations  



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.