Manager, Study Management, Global Medical AffairsLocation Tokyo, Japan Workstyle Open to Hybrid Apply
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.
The 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 within Japan to ensure high quality deliverables. The Manager is responsible for the implementation of study(ies) across multiple products, including but not limited to protocol development, study oversight (timelines, planning, and budgets), quality, compliance, meeting facilitation, vendor management, and study reporting.
This individual is also a member of the Asia Pacific (APAC) regional Medical Affairs Team supporting the dissemination of information regarding local study status to the regional head and other members of the APAC organization as appropriate.
In addition, the individual in this position within Japan will be responsible for managing the day-to-day activities associated with post marketing surveillance studies.
The individual in this position exhibits advanced level skills related to communication, compliance, clinical trial, and project management. S/he has foundational level skills related to problem solving, strategic planning and leadership.
Post-Marketing Surveillance (PMS) Studies
- Develop materials for submission to regulators in collaboration with cross-functional partners
- Ensure safety is reported according to BioMarin Pharmacovigilance processes, global and country specific regulations
- Conduct advisory board meetings with investigators in collaboration with the medical monitor to provide updates on the PMS program
- Audit study files to ensure they are ready for regulatory inspection
- Review and approve vendor contracts and accruals
- Manage vendors across assigned product, including vendor contract negotiation, oversight of change orders, and budgeting, in collaboration with study managers
- Accountable for vendor performance at a product level, including performance metrics
- Approve selected vendors in collaboration with Program Director and cross-functional business partners
Trial Management and Essential Documents
- In collaboration with study team members and global project management establish reasonable study timelines that will meet program objectives
- Facilitate and manage monthly medical affairs study team (MAST) meetings, including review and approval of agendas minutes and distribution of study updates within team
- Responsible for the writing, review, and approval of key study documents, including but not limited to protocols, regulatory reports, and study reports
- Partner with the Medical Monitor and/or Medical Science Liaisons to support study execution activities for all studies conducted in Japan including but not limited to site 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
- Develop study-level plans (eg, monitoring plan, data management plan)
- Develop and manage the budget for assigned study(ies), including tracking monthly spend against planned, providing leadership with updates
Metrics, Data Collection, and Data Quality
- Accountable for the development and utilization of metrics and management reporting tools for efficient trial 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
- Responsible for the identification of issues/trends across studies
- Participate in the review of the statistical analysis plan and statistical output (eg, tables, listings, graphs) as appropriate
Compliance and Risk Management
- Accountable for quality, timeliness, and compliance of execution of studies conducted in Japan
- Escalation of challenges that are unable to be resolved by the MAST to the Medical Affairs Program Team (MAPt), Medical Affairs APAC Regional Medical Head
A Manager demonstrates advanced competence in Communication, along with foundational skill in Leadership, Strategic Thinking and Planning, and Problem Solving and Decision Making. Skills include:
- Distilling complex issues to simple terms, while driving information dissemination up and down the organization to influence appropriate outcomes
- Ensuring that team roles and responsibilities are clearly defined, understood, and fulfilled
- Contributing to the development of a motivating team/work environment by upholding positive morale and encouraging high performance
- Demonstrating an ability to recognize, understand, articulate and respond promptly to issues that arise, escalating as appropriate
- Excellent written and verbal English communication skills
The Manager is also expected to demonstrate advanced technical competence in Compliance and Clinical Trial and Project Management. This includes:
- Demonstrating robust knowledge of GCP and GVP guidelines and their impact on each stage of the trial (start-up through close-out)
- Ability to identify and mitigate compliance risks across a clinical trial
- Demonstrating command of site management and co-monitoring
EDUCATION AND EXPERIENCE
- BA/BS or higher in nursing, life or health sciences is preferred. Industry or relevant experience in lieu of education is considered.
- 6 years of pharmaceutical industry experience
- 4 years of experience in clinical research, including:
- Experience operationalizing PMS studies, including thorough knowledge of regulations governing their management
- Managing PMS studies for global companies in a matrix environment
- Some line management experience (0-2 years) is preferred
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.