Longboard Pharmaceuticals Hiring for Vice President, Head of Operations at San Diego, CA Full Time

Position Summary

The Vice President, Head of Operations will lead the development of the organization to ensure best in class clinical trial planning and execution in accordance with associated regulatory guidelines. They will be responsible for leading a team to oversee all aspects of clinical study conduct including site selection, contract negotiations, study start-up, conduct and real time data delivery, providing leadership and resolution of trial and/or program specific issues to deliver high-quality clinical trial results. This role reports directly into the Executive Vice President, Head of Operations.

Responsibilities Include But May Not Be Limited To

• Build and lead a clinical operation team to support the scope of our clinical development programs
• Provide clinical operations leadership and oversight for all study activities including site identification and selection, enrollment models, clinical supply planning, CRO and vendor selection and contract negotiations, budget planning and trial execution
• Develop and execute upon the clinical operations strategy
• Develop clinical operation SOPs
• Development of the subject recruitment/retention strategy and related initiatives
• Lead the full-service Contract Research Organizations (CROs) and other third party vendor selection process, specification development, and management/oversight of all clinical vendors
• Lead preparation and response team for FDA and other internal and external inspections
• Development/management of vendor scope of work (SOW) per contract, quality, and budget
• Development, management, maintenance of study deliverables [i.e. timelines, study plans, etc.] through collaboration with internal and external stakeholders using data and strong inter-personal influencing skills to make robust data driven decisions.
• Work closely with external collaboration partners with a focus on relationship management and efficiency
• Partner closely with the cross functional teams to design, plan and execute on innovative clinical trial designs
• Lead the proactive identification, assessment, and management of clinical study challenges and risks
• Lead the professional development of clinical operations team members, promoting career growth and advancement

Minimum Requirements

• 12-15 years of clinical trial management experience required, late state experience highly preferred
• 5+ years in a leadership role
• Bachelor’s Degree required, advance degree preferred
• Experience working in a startup environment
• Neurology or CNS experience preferred
• Excellent understanding and demonstrated application of FDA guidelines and Good Clinical Practices
• Experience building a high performing team including mentoring and training team members
• Ability to evaluate medical data and proficient knowledge of medical terminology
• Strong verbal and written communication skills
• Ability to effectively communicate and influence senior level stakeholders to gain buy-in on clinical strategy
• Travel up to 20%