Sr. Manager, Evidence Generation & Study Management
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’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development 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 rare diseases. Come join our team and make a meaningful impact on patients’ lives.
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 market access needs and regulatory commitments. 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 prospective and retrospective data collection support BioMarin products.
The Sr. Manager is an essential position within GMAF Study Management (SM) and the Evidence Generation Center of Excellence focusing on leading day-to-day management of study activities and supporting the development of operational program strategies to ensure high quality deliverables. The Sr. Manager is responsible for the execution of study(ies) across a product, including but not limited to protocol development, study oversight (timelines, planning, and budgets), quality, compliance, meeting facilitation, vendor management, and study reporting. In addition, the Sr Manager may be expected to lead study execution at a program level including activities such as vendor selection and oversight, proactive risk management program level timelines and budget, review of data outputs and regulatory reporting. The Sr. Manager will oversee and provide guidance to study managers who are responsible for the conduct of studies within the program.
This role also leads / supports cross-functional initiatives, including departmental process improvements and best practice.
The individual in this position exhibits advanced level skills related to communication, compliance, clinical trial, and project management. S/he has advanced technical skills related to compliance, problem solving. strategic planning and people management capabilities.Key Responsibilities
Responsibilities may include, but are not limited to:
- Develop and oversee program budgets in collaboration with Program Director
- Select and approve vendors in collaboration with Program Director and cross-functional business partners
- Manage vendors across assigned program, including vendor contract negotiation, oversight of change orders, accruals and budgeting, in collaboration with Study Manager(s)
- Accountable for vendor performance at a program level, including performance metrics
Study Oversight and Essential Documents
The Sr. Manager may perform the activities below or be responsible for oversight of assigned study managers when managing multiple studies across a program.
- Establish reasonable timelines that will meet program objectives; and lead a cross-functional team to meet these timelines
- Facilitate short- and long-term planning, including development and monitoring of progress against timelines, for assigned study(ies)
- Facilitate and manage monthly Medical Affairs Study Team (MAST) meetings, including review and approval of agendas, minutes and distribution of study updates
- Coordinate cross functional input into study design development, writing, review, and approval of key study documents, including but not limited to protocols, regulatory reports, and study reports in collaboration with the Program Director
- Partner with the Medical Monitor/ Director and/or Medical Science Liaisons to support study execution activities including but not limited to site and country feasibility/selection, addressing site and/or Ethics Committee questions, training of study team
- Accountable for product forecasting for interventional studies in collaboration with clinical supply chain
- Approve study-level plans (eg, monitoring plan, data management plan)
- Develop and manage the budget for assigned study(ies), including tracking monthly spend against planned, scenario planning, reforecasting and providing leadership with updates
- Provide operational expertise throughout study design and facilitate achievement of goals for program
- Manage program level operational level issues and oversight of study team issue escalation
Metrics, Data Collection, and Data Quality
- Accountable for the development and utilization of metrics and management of reporting tools for efficient study execution
- Responsible for participating in the design and utilization of data review tools and data collection initiatives by assigned Study Team members, and resolution of identified issues
- Address discrepancies, trends, or issues identified during data review process, including adverse event reconciliation
- Participate in the review of the statistical analysis plan and statistical output (eg, tables, listings, graphs)
Compliance and Risk Management
- Accountable for quality, timeliness, and compliance of execution of studies
- Anticipate and identify potential risks, mitigations, and lead development of study level risk mitigation plan
- Escalation of challenges that are unable to be resolved by the MAST to the Medical Affairs Program Team (MAPt)
In addition to the above, the Sr. Manager may be required to conduct the following activities:
- Together with Project Management, create program level timelines and contribute to the tracking of program level drivers
- Manage the program level study management budget for an assigned product, including tracking monthly spend against planned, scenario planning, reforecasting and providing leadership with updates
- Responsible for the creation of study concept documents, leading a cross-functional team
- Responsible for the identification of issues/trends across assigned program. Escalate as necessary to MAPt, the Program Director, Medical Director and Leadership
- Anticipate and identify potential risks, mitigations, and lead development of product level risk mitigation plan
People Management and Development
- Oversee and provide guidance to Managers, Trial Specialists, Trial Associates, and Site Managers/CRAs
- Manage performance of direct reports, including facilitating training and development
The Sr. Manager demonstrates advanced competence in communication, leadership, strategic thinking, planning, with foundational skills in problem solving and decision making. This includes (but is not limited to):
- Distilling complex issues to simple terms, while driving information dissemination up and down the organization to influence appropriate outcomes
- Maintains composure while acknowledging and listening to differing viewpoints, identifying discrepancies and gathering additional information
- Develops contingency plans for potential risks
- Demonstrating an ability to recognize, understand, articulate and respond promptly to issues that arise, escalating as appropriate
- Contributing to the development of a motivating team/work environment by upholding positive morale and encouraging high performance
The Sr. Manager is also expected to demonstrate advanced technical competence in compliance, drug development, regulatory environments and clinical trial and project management. This includes (but is not limited to):
- Demonstrating robust knowledge of GCP and GVP guidelines and their impact on each stage of the trial (start-up through close-out)
- Actively contributes to product development and trial execution strategies
- Demonstrates understanding of protocol objectives, endpoints and evidence needed for effective study execution and outcomes
BioMarin offers comprehensive career development programming, including guidance, targeted training opportunities, and mentorship programming. A career development pathway for GMAF has been defined and is available to employees of BioMarin.
The Sr. Manager is expected to manage up to 4 direct reports; actual number of direct reports may vary depending on business needs
- BA/BS or higher in life or health sciences preferred. Industry or relevant experience in lieu of education accepted
- 7 years of relevant experience in clinical science, clinical trial or site management, medical affairs, and/or drug development
- Some line management experience (0-3years) preferred
- Absent a medical or religious reason that prohibits vaccinations, all our incoming employees must be vaccinated.
This is a remote position.
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.