Executive Clinical Director, Strategy, Scientific Collaborations and Policy

Location:  remote, United States Category: Safety & Pharmacovigilance

Description

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.

Reporting to the Group Vice President Worldwide Research and Development (WWRD) Strategy, Scientific Collaborations and Policy (SSCP), the Executive Clinical Director, Strategic Risk Management will lead the Strategic Risk Management team and acts as a key partner with clinical and scientific leads and well as senior leaders across the BioMarin to ensure excellence in execution of program strategy, learning, sharing and incorporating best practices, and incorporating expert stakeholder insights to adapt and inform future direction.

 

The Executive Clinical Director will develop and implement an approach that supports continuous strategic risk and opportunity assessment and management to support decision making across programs, will ensure the team’s product-based SRM strategy is developed across all products in partnership with key leads and SMEs including the Clinical Development lead, Global Regulatory Lead, Core Team Lead, and functional leadership. They will provide oversight for the management of Expert Advisory Councils  to support external collaborations. The SRM lead will be responsible for establishing and partnering across the BioMarin enterprise on specific initiatives and will partner with key groups such as Clinical Sciences, Biometrics, Regulatory Affairs, Medical Affairs, and Product and Portfolio Development, ensuring key insights are incorporated across strategy, communications and relevant critical documents and submissions.

 

  • Translate corporate strategy into key program and cross-portfolio SRM strategy
  • Lead cross-functional risk and opportunity assessments ensuring focus on the most important issues impacting WWRD strategy and key decisions. Plan EACs including cross functional meetings to generate content and align on key objectives
  • Define Expert Advisory Council (EAC) needs across portfolio based on business priorities, and lead strategy development for EACs. Accountable for successful implementation of SRM strategy
  • Ensure activities and outputs are targeted, and impactful to support strategic decision-making through the lifecycle of the programs
  • Assess EAC feedback and learnings, and define critical next steps for socialization and assessment through governance, as well as impact to business priorities and resources
  • Accountable for the management and actioning of key risks and opportunities, serving as a champion across the organization and ensuring learnings are incorporated in decision-making and across relevant deliverables such as clinical protocols, regulatory submissions and health authority engagements
  • Ensure appropriate sharing of learnings with executive leadership, cross functional stakeholders including internally in SSCP
  • Identify, maintain and manage a high caliber roster of experts ensuring continued relationship development and appropriate and impactful relationships
  • Manage budget, lead and develop team

 

 

Qualifications

  • MD with experience in research & development is preferred (close equivalent will be considered).
  • Minimum of 12 years of experience.
  • Experience leading and developing teams including matrixed teams
  • Ability to influence without direct management accountability
  • Visionary, ability to think outside the box, ask the right questions, detail oriented, action driven, timely and responsive
  • A confident yet agile personality, and ability to work in a dynamic environment is required.
  • Ability to manage internal and external networks in a matrixed environment is required.
  • Demonstrated thorough knowledge of R&D processes and the global landscape and key issues for biopharmaceutical science and innovation is required.
  • Strong experience in crisis/issues management and the ability to manage multiple priorities in a fast-paced, global matrix environment is required.

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.