Sr. Director Medical Affairs Study Management and Evidence Generation
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 (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.
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, but is not limited to, development and execution of operational program strategy(ies), execution of evidence generation activities, peri- and post-approval studies and efficient, comprehensive, and compliant data collection to support BioMarin products.
Come join our team and make a meaningful impact on patients’ lives.
The Sr. Director is accountable for the operational strategy and execution of evidence generation activities across multiple products, including but not limited to peri- and post-approval studies. The individual in this position is a key contributor for 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 for the Sr. Director 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.
Responsibilities may include, but are not limited to:
- Represent Evidence Generation Center of Excellence and Study Management on cross-functional program teams (eg, Strategic Medical Affairs Team, Clinical Development Team, Data and Evidence Integration Team)
- Develop the operational strategy supporting execution of peri- and post-approval studies
- 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
- Provide operational input into strategic plans (eg, Brand Plans, Strategic Medical Plan)
- Accountable for the development of protocol concept documents to support identifications of risks and feasibility of proposed study designs identified to address evidence gaps and/or regulatory commitments
- Present strategic study plans, budget requirements and operational execution deliverables for their assigned product 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
- Accountable for program level budget development process, long range planning, managing spend, and providing leadership with updates
- Oversight of quality and compliance for studies within assigned program(s), including corporate governance metrics, participation in and responses to inspections, audits and corrective and preventative action plans
People Management and Development
- Mentor and manage performance of direct reports, including facilitating training and professional development
- Accountable for recruitment and resource assignment of GMAF Study Management staff
The Sr. Director is expected to exhibit mastery-level understanding of multiple core competencies, including communication, leadership, strategic thinking, and people management. As a Sr. Director, mastery of drug development lifecycle and therapeutic area knowledge are essential
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
Internal: Clinical Operations, Clinical Sciences, Pipeline Commercialization, Market Access, Scientific Communications, Regulatory Affairs, Patient Advocacy, Medical Directors, Medical Science Liaisons, Medical Information, Legal, Corporate Ethics & Compliance, Corporate Communications, Pharmacovigilance, Biometrics, Development Sciences Quality (DSQ), Business OperationsExternal: Clinical Trial Site Staff, key opinion leaders, vendors and suppliers
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.
This is a remote position.