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Associate Director, Medical Affairs Study Management & Data Analytics

Location San Rafael, California
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. 

SUMMARY DESCRIPTION

The Associate Director is responsible for managing multiple trials within a product. This is a leadership management role with opportunity for strategic influence. The Associate Director is expected to assume a variety of additional leadership responsibilities, including leading process improvement and change management initiatives within SMDA. Typical areas of focus for the Associate Director include risk and issue management, decision making facilitation, and active management of a team of direct reports.

The individual in this position exhibits mastery of communication, compliance, clinical trial, and project management. S/he also demonstrates advanced skills related to problem solving, decision making, people management, strategic planning, and business acumen.

KEY RESPONSIBILITIES:

Responsibilities may include, but are not limited to:

Contracts and Vendor Management

  • Oversee budgets for all trials within assigned product, including tracking annual spend against planned, providing updates, and contributing to annual budget development and long range plan
  • Manage vendors and hold accountability for vendor performance across assigned product, including vendor contract negotiation, oversight of change orders, ensuring completion of training, and budgeting

Trial Oversight

  • Accountable for writing study documents, including but not limited to protocols, regulatory reports, and study reports
  • Accountable for review and approval of trial level plans
  • Accountable for product forecasting across all supply chain activities
  • Facilitate and manage quarterly cross-functional product team meetings, including review and approval of agendas and minutes
  • Review and provide study updates on all trials within a product to colleagues and management
  • Participate in the development of the global publication plan for assigned product
  • Provide leadership and direction to staff working on trials for assigned product
  • Responsible for efficient and timely execution of assigned trials

Data Quality and Compliance

  • Establish and implement periodic data collection and cleaning initiatives
  • Approve study metrics to monitor progress against study goals.
  • Participate in ongoing data review as outlined in data review plan
  • Address discrepancies, trends, or issues identified during data review process, including safety event reconciliation

Compliance and Risk Management

  • Responsible for issue identification, management and escalation, where appropriate
  • Lead development of trial and product level risk mitigation plan
  • Anticipate and identify potential risks and implement mitigation strategies
  • Accountable for ensuring adherence to quality standards

People Management, Strategic Leadership, and Change Management

  • Provide input into departmental process improvements, organizational change projects, and company initiatives
  • Responsible for the implementation of product/trial transition plans between Clinical Operations and GMAF SMDA
  • Manage performance of direct reports (including training, professional development, recruiting, hiring and retention, etc.)

COMPETENCIES

It is expected that the Associate Director has the experience and knowledge required to demonstrate a mastery of the communication and collaboration core competency, as well as advanced skill in problem solving and people management. The individual in this role will be required to, for example:

  • Actively foster and maintain productive strategic working relationships with key influential individuals and organizations
  • Adeptly match individual capabilities to functional objectives and environment
  • Recognize cross-functional, company-wide, or vendor-based impacts of the issues and opportunities that arise, and appropriately consider input and implications when developing solutions
  • Works with staff to better understand their strengths and contributions and proactively arrange projects to challenge team members and stretch their abilities and self-confidence

The Associate Director is expected to have mastered the compliance and clinical trial management technical competencies. For example, the Associate Director should:

  • Demonstrate robust knowledge of GCP and GVP guidelines and their impact on each stage of the trial (start-up through close-out), actively contributing to discussions with vendors and the project team on GCP/GVP compliance issues
  • Be able to organize within and across departments, marshalling resources and information efficiently and effectively to accomplish trial or project goals

EDUCATION AND EXPERIENCE

  • BS in life or health sciences. Advanced degree preferred. Industry or relevant experience in lieu of education accepted.
  • 10 or more years of relevant experience in clinical science, clinical trial or site management, medical affairs, and/or drug development
  • 5 or more years of line management experience preferred

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

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