Director, Global Medical Affairs Study Management
BioMarin Global Medical Affairs 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 Global Medical Affairs (GMAF) offers scientific and clinical expertise to post-marketing products through the direction and planning of medical communications, support of education and research, liaising with the medical community, response to incoming inquiries about Medical Affairs products and trials, and leadership of the execution of Medical Affairs trials.
Within GMAF, the Study Management (SM) group is responsible for managing the strategy, execution, and analytics behind BioMarin’s studies, ensuring efficient, comprehensive, and compliant data collection to support BioMarin products.
The Director is accountable for all GMAF SM activities across multiple products. The Director is responsible for developing the strategy for GMAF SM across their assigned products and is a key contributor to cross-functional strategy within GMAF SM. The Director is 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 Director include people management, proactive risk and issue identification, development of mitigation strategies, cross-functional program team leadership, and successful trial execution within assigned products.
The individual in this position exhibits advanced skills in problem solving and decision making. S/he exhibits mastery of all other GMAF SM core and technical competencies.
Responsibilities may include, but are not limited to:
Contracts and Vendor Management
- Accountable for study level governance across assigned products
- Accountable for annual budget development process, managing spend, long range planning, and providing GMAF SM leadership with budget updates
- Accountable for vendor selection, vendor relationship management, and review and approval of vendor contracts and budget
Trial Oversight and Communication
- Provide leadership and guidance on GMAF SM trial startup, management, and oversight
- Accountable for quality, timeliness, and compliance of implementation of global programs across assigned products
- Accountable for product forecasting across all supply chain activities
- Accountable for periodic regulatory reports
- Provide key trial and product updates to all levels within GMAF (e.g. matrix team meeting)
- Facilitate and manage quarterly cross-functional product team meetings
Data Quality and Compliance
- Collaborate cross-functionally in the development and/or implementation of controlled documents
- Responsible for identification, resolution, and escalation of risks, issues, and trends across assigned products
- Accountable for quality and compliance, including responses to internal/external audits and corrective and preventative action plan
- Mentor and manage performance of direct reports, including facilitating training and professional development
- Accountable for resourcing plans and recruitment of GMAF SMDA staff
Strategic Leadership and Change Management
- Lead the cross-functional Program Team, including facilitating development of an integrated data evidence plan supporting the post-marketing lifecycle management of approved products
- Develop and maintain strategic business relationships internally and externally for the post-marketing lifecycle management of approved products
- Provide input or lead departmental process improvement and company initiatives
- Work with Head of GMAF SM to develop plans for organizational changes
The Director is expected to exhibit mastery-level understanding of multiple core competencies, including leadership, strategic thinking, and people management. This includes (but is not limited to):
- Develop a team and/or functional culture of expecting and delivering on high performance standards
- Understand the strategic impact of GMAF SM activities on competitive positioning and regulatory environment
- Acknowledge the progress, growth and success of individuals and teams to inspire and motivate, while proactively addressing issues that may impact staff morale
As a Director, mastery of drug development and therapeutic area knowledge are essential. This includes (but is not limited to):
- Actively sought out to contribute to cross-functional discussions regarding drug development strategy and planning, confidentiality issues, and regulatory issues
- Subject matter expertise on the global competitive environment for executing a clinical program / clinical trial in a particular therapeutic area or disease condition
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 Director may manage up to 6 direct reports and multiple hierarchal levels of reports
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, clinical trial or site management, medical affairs, and/or drug development
- 6 or more years of line management experience preferred
WORK DEMANDS / PHYSICAL DEMANDS / TRAVEL:
The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.
Computer work utilizing common business software programs and hardware solutions.
Internal: Clinical Operations, Pipeline Commercialization, Market Access, Medical Communications, Regulatory Affairs, Patient Advocacy, Medical Directors and Medical Science Liaisons, Medical Information, Legal, Corporate Ethics & Compliance, Corporate Communications, Pharmacovigilance, Biometrics, Development Sciences Quality (DSQ), Business Operations
External: Clinical Trial Site Staff, vendors and suppliers