VP, Clinical Operations
Location: Emeryville, CA
Department: Clinical Development - Fintepla
Zogenix is a growing company in the field of rare diseases, and this position encompasses management of research in North America, Europe and Japan, with potential for expansion. The Vice President of Global Clinical Operations, reporting to the Chief Development Officer, will contribute to corporate leadership and strategy, and partner closely with their counterparts in Clinical Development, Quality, Finance, Legal, Regulatory Affairs, Project Management and Pharmacovigilance to collect and deliver high quality data to support our corporate aims. In this position, the ideal candidate will be responsible for the management of Phase 1 to 3 stage clinical programs. This individual sees ahead clearly, can anticipate future trends, and has a broad knowledge and perspective of clinical operations and development.
- Inspire the team of professionals in the Clinical Operations organization to design and deliver high quality clinical trials and study reports while expertly navigating global requirements and managing vendors.
- Ensure clinical programs are managed and executed with the highest quality and integrity in site execution; CRO oversight, compliance to SOPs, protocols, management plans and budget.
- Grow, develop and mentor the team to improve processes, display leadership, and collaborate to execute the functions of the department as a best-in-class organization.
- Oversee staffing and training for the department for both FTEs and contractors.
- Partner with Clinical Development and other stakeholders on creating Clinical Development Plans.
- Develop strategy and drive implementation of Phase 1 to 3 clinical operation plans and timelines, working cooperatively across the company.
- Ensure high quality data collection and data management, with appropriate oversight of vendors providing data management services.
- In collaboration with Clinical Development, Project Management, Finance and other stakeholders, oversee clinical project schedules, timelines, budgets and key performance milestones to meet corporate objectives.
- Direct the selection of clinical CROs and other vendors and lead management of the vendor relationship to maintain cooperative and productive study support.
- Partner with Legal and Finance to negotiate clinical vendor budgets and change orders, and oversee a department budget adherence.
- Review US, EU and other applicable regulatory guidance on clinical trial operations to ensure compliance to necessary regulations and inspection preparedness in all regions.
- Direct the implementation of clinical standard operating procedures (SOPs) that meet ICH, EMA and FDA requirements.
- Provide oversight to ensure SOPs are followed across all programs, including with CROs, central laboratories, data management, , and other third-party vendors.
- Oversee and maintain clinical trial master files and other clinical documents to ensure inspection readiness at all times.
- Collaborate closely with internal translational medicine and business development teams to support preclinical assets into Phase 1 / Phase 2 clinical trials, aligning clinical goals with the Company’s corporate goals.
- Support the company's Business Development efforts in the assessment of new product candidates if needed or requested.
- Effectively and articulately present updates, strategies, plans, and data to company leadership.
- Other duties as assigned.
Qualifications, Skills and Experience:
- Ph.D., PharmD or other relevant post-graduate level training strongly preferred with a minimum of 15 years of industry experience in running multinational clinical operations or related activities
- Excellent working knowledge of FDA and EMA regulations and expectations, GCPs, ICH guidelines, and all phases of clinical drug development. Successful record of global approvals is preferred. Additional regional experience a plus.
- Strong leadership and proven track record in successful implementation and completion of clinical trial programs leading to successful registration, with adherence to timelines and budgets. Ability to lead under pressure, manage and resolve conflicts and successfully implement new initiatives.
- Highly motivated, accountable individual with excellent organizational, interpersonal and communication skills and experience working in geographically distributed teams and interacting with all levels of the organization.
- Excellent knowledge of pharmaceutical business, global drug development and regulatory process.
- Ability to respond to complex operational challenges with innovative solutions supported by appropriate tactics.
- Proven track record of both strategic and tactical capabilities, demonstrating both the ability to innovate and execute
- Strong financial acumen with experience in budgeting models and spreadsheets
- Proactive management style, possessing strong motivational and leadership skills. Proven track record in building and leading teams
- Expert partnering and negotiating skills to support management of our external vendors is required.
- Additional experience in clinical pharmacology, data management, pharmacovigilance, medical science, or CRO experience is a plus
- Position may travel up to 25%