Vice President, Global Clinical Operations

Location:  San Rafael, California Category: Clinical

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.

The successful candidate will provide strong leadership and oversight of the Clinical Operations function, including the management of cross-functional Study Execution Teams across multiple rare disease indications (San Rafael, London and remote-based staff). The leader will interact with BioMarin’s senior and executive leaders as well as BioMarin’s Board of Directors, and will serve as a key contributor to BioMarin’s clinical development strategies. The leader will be a standing member of several teams and governance forums including the DSO Leadership Team, BioMarin’s Cross-Functional Development Review Committee, Worldwide Research and Development (WWRD) Compliance-Quality Forum and the WWRD Leadership Team Forum.

Key Responsibilities:

  • Provide leadership, strategic oversight, and guidance of Clinical Operations to generate high quality and reliable clinical trial data on time and on budget.
  • Ensure compliance with all SOPs, ICH-GCP guidelines, regulatory authority regulations and patient safety standards in the conduct of clinical trial execution.
  • Provide effective and constructive integration of clinical operations knowledge and expertise into all applicable Clinical Development activities including integrated clinical development plans and study protocols. Continue to develop a high performing Clinical Operations team globally, with responsibility for identifying and implementing scalable business processes and incorporating lessons learned for effective global study management.
  • Establish and maintain strong communication and collaboration with WWRD Leaders; represent all aspects of Clinical Operations and provide systematic & ongoing updates to senior and executive leadership and other key internal stakeholders.
  • Engage in robust and frequent dialog with the Clinical Operations team, including communicating business decisions and their impact on Clinical Operations.
  • Maintain a positive team-based culture that is conducive to attracting, retaining and motivating the Clinical Operations team. Ensure all employees have clear and measurable goals and development plans in place.
  • Drive quarterly coaching conversations and talent reviews to identify retention or engagement issues with top talent; implement engagement or retention plans as appropriate.
  • Ensure effective oversight of CROs and other third-party vendors and build highly effective relationships to produce quality deliverables, in partnership with Development Sciences Business Operations.

 

Candidate Profile

The ideal candidate will be a business-minded individual who possesses excellent technical competencies and management skills with 15 or more years of biopharmaceutical development experience. Being business-minded will enable the VP of CLO to seamlessly tie the corporate objectives to the technical deliverables and to effectively and consistently deliver high quality data on time and on budget. The ideal candidate will bring best practices to enable timely start-up and conduct of clinical trials and will be committed to tracking performance through pre-specified metrics. The ideal candidate will also be passionate about delivering study quality and will bring insights about the protocol adherence measures that matter most. Technically, the candidate must have command of GCPs and ICH Guidelines governing the conduct of clinical trials, good working knowledge of FDA and EMA regulations and expertise in the execution of clinical trials in rare disease settings. From a management and leadership perspective, the VP of CLO must have a track record of managing a clinical operations organization and mentoring and leading clinical operations professionals. The individual must also be savvy at interacting with and presenting to leaders of the organization including the CMO, Executive President of WWRD and the CEO at BioMarin.

 

Additionally, the ideal candidate will have:

  • Experience with multiple successful regulatory submissions (NDA/BLA/MAA) reviews and approvals, including clinical trial site and sponsor GCP inspection management. 
  • Extensive experience managing global CROs and other third-party vendors in support of clinical trial execution.
  • Strong interpersonal skills and the ability to collaborate and interface effectively. 

 

In terms of the leadership competencies required for this position, we would highlight the following:

Strategic Mindset

Anticipates future trends and implications accurately, has a broad knowledge and perspective of clinical operations and clinical development. Sees the big picture; able to articulately and succinctly paint credible pictures and visions of possibilities and probabilities to executive management. Inspires and motivates entire groups to the highest levels of performance and quality within the organization.

 

Driving for Results

Consistently achieves results, even under challenging circumstances. Sets aggressive but achievable goals and has high standards. Pursues everything with energy, drive, and the need to finish. Persists in the face of challenges and setbacks. Always keeps the end in sight; pushes self and helps others to achieve results.

Building Relationships and Using Influence

Ability to lead a matrixed team through influence. Achieves this influence and level of leadership through maintenance of the highest levels of integrity and trust. Builds and sustains excellent relationships at multiple levels within the organization and with external key stakeholders such as clinical investigators, academics, clinical trial vendors, and others. Radiates enthusiasm for corporate and clinical development goals and inspires others with shared sense of optimism and excitement which motivates employees to embrace goals and high levels of performance.

 

Decision Quality

Decisively makes high-quality decisions, even when based on incomplete information in the face of uncertainty. Actively seeks input from pertinent sources to make timely and well-informed decisions. Skillfully separates opinions from facts and considers many perspectives objectively. Is respected by others for displaying superior judgement.

 

Managing Ambiguity

Deals comfortably with the uncertainty of change. Effectively handles risk. Is calm and productive, even when things are up in the air. Deals constructively with problems that may not have clear solutions or outcomes. Adapts quickly to changing conditions and is a calming leader to their group in times of uncertainty.

 

Ensuring Accountability

Assumes the responsibility for the outcomes of others. Promotes a sense of urgency and establishes and enforces individual and team accountability.  Is completely on top of what is going on and knows where things stand. Provides balanced feedback at the most critical times. Establishes clear responsibilities and processes for monitoring work and measuring results.

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.