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Sr. Director, Evidence Generation & Study Management

Location United States, Remote

Workstyle Open to Hybrid

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin Global Medical Affairs Evidence Generation Center of Excellence

BioMarin Global Medical Affairs (GMAF) drives BioMarin’s scientific strategy to enhance patients’ lives and health outcomes through appropriate evidence-based use of our medicines in real-world integrated clinical care clinical expertise for peri- and post-approval products through the direction and planning of scientific communication, support of education and research, interactions with the medical community, response to incoming inquiries about products and trials, leadership in evidence generation, including the execution of GMAF sponsored studies. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases.

Within GMAF, the Evidence Generation Center of Excellence includes study management and is accountable globally for the prioritized and strategic development of evidence to address clinical practice questions and drive clinical development strategy(ies) with prospective and retrospective research studies. This includes development of the tactics for the conduct of prospective trials to address regulatory requirements and other evidence needs, development and conduct of Risk Evaluation and Mitigation Strategies and facilitation of BioMarin’s Investigator and Collaborative Research Program.

Come join our team and make a meaningful impact on patients’ lives.

SUMMARY DESCRIPTION
The Sr. Director is a key position within the GMAF Evidence Generation COE.  This individual is accountable for developing the operational strategy and execution of evidence generation activities across multiple products. They are a key contributor to strategic cross-functional plans (eg, Medical Plan, Data & Evidence Integration Plan) within the organization. The Sr. Director may be responsible for leading cross-functional initiatives, including departmental process improvements, and may act as an advocate for the group across the organization. Key areas of focus include people management, cross-functional proactive risk and issue identification, development of mitigation strategies and cross-functional program leadership, within assigned products.

The individual in this position exhibits advanced skills in operational strategy, problem solving and decision making. S/he exhibits mastery of all other GMAF Study Management and Evidence Generation core and technical competencies.

KEY RESPONSIBILITIES
Responsibilities may include, but are not limited to:

Program Strategy

  • Represent Evidence Generation Center of Excellence on cross-functional program teams (eg, Strategic Medical Affairs Team, Clinical Development Team, Data and Evidence Integration Team) providing operational input into strategic plans (eg, Brand Plans, Strategic Medical Plan)

  • Develop the operational strategy supporting execution of peri- and post-approval evidence generation

  • Collaborate with key stakeholders to design study-based solutions to data gaps identified in the integrated data evidence plan (IDEP)

  • Provide input into regulatory documents (eg, Risk Management Plan, Response to Questions, periodic product safety reports)

  • Lead cross-functional teams to design appropriate real-world evidence plans to meet post-approval study requests from regulators

  • Accountable for the development of protocol concept documents to support identification of risks and feasibility of proposed study designs developed to address evidence gaps and/or regulatory commitments

  • Develop and present strategic evidence generation plans, budget requirements and operational execution deliverables for their assigned program at various governance meetings

  • Establish and lead the cross-functional Medical Affairs Program Team (MAPt)

  • Develop and maintain internal and external partnerships for the post-marketing lifecycle management of approved products

Study Oversight and Communication

  • Provide leadership and guidance to Medical Affairs Study Team (MAST) members on the operational execution of peri-and post-approval studies across assigned programs, including but not limited to protocol and study plan development, issue mitigation, and inspection readiness

  • Accountable for the quality and integrity of protocols and study reports

  • Review and input into study documents including statistical analysis plans, tables, listings and graphs to ensure strategic alignment with assigned program deliverables

  • Accountable for study result dissemination

EDUCATION AND EXPERIENCE

  • BS in life or health sciences. Advanced degree preferred. Industry or relevant experience in lieu of education accepted.

  • 12 or more years of relevant experience in clinical science, study or site management, medical affairs, and/or drug development

  • 6 or more years of line management experience preferred

PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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