Executive Director/Vice President, Clinical Operations

Job Type

Full-time

Description

Ventyx Biosciences, Inc. is a clinical-stage, public biopharmaceutical company focused on advancing new therapies for millions of people living with inflammatory diseases and autoimmune disorders. We are developing novel and differentiated therapeutics that target both the innate and adaptive immune system. Our clinical-stage programs include an allosteric TYK2 inhibitor for the treatment of a broad range of autoimmune diseases, an S1P1 receptor modulator for the treatment of ulcerative colitis, and a peripheral inhibitor of the NLRP3 inflammasome, which is a mediator of multiple inflammatory conditions. Join this team of life science professionals to bring this portfolio of programs to fruition.

The Opportunity: Executive Director/Vice President, Clinical Operations

The Senior Director/Executive Director of Clinical Operations will ensure that clinical strategies and study protocols are translated into operational plans for assigned studies. Works closely with Clinical Development and functions to ensure high quality deliverables. This role will be responsible for overseeing a programs or indications as assigned.

What You Will Contribute

• Lead the clinical operations team in successful trial conduct while ensuring the trial is conducted according to corporate timelines and budget
• Demonstrated leadership in the planning, execution, and completion of clinical trials – on-time, on-budget and adhering to all regulatory and patient safety requirements
• Oversees the completion of all study-related plans and systems according to timelines and standards
• Contributes to ongoing department infrastructure development efforts such as SOP development, implementation and/or innovation of new processes for assigned studies within the department.
• Responsible for oversight of program budget, and vendor contracts, budgets, and approval of invoices
• Proactively identifies risks and resolves operational issues/processes to ensure achievement of study milestones, data quality and data integrity; escalates study-related issues, risks and mitigation plans to management in a timely manner
• Provides oversight for the setup, maintenance, and close-out of the Trial Master File and ensures it is complete and audit ready
• Develop and drive aggressive recruitment strategies, developing slides and presenting as needed to teams and leadership
• Interacts with and participates in strategy discussions with other functional areas and key stakeholders, including Clinical Development, CMC, early development, and clinical vendors (e.g., central laboratory, CROs), as needed, to provide a clinical operations perspective
• Participates in the selection and oversight of Contract Research Organizations (CROs) and vendors
• Partner effectively with CROs, vendors, investigators, and key stakeholders
• May have functional reporting responsibilities or indirect reports (e.g., study team members)
• Point of escalation for identified risks and mitigates with team as appropriate
• Supports audit/inspection activities as needed
• Maintain clinical trial registry entry/updates, as required
• Provides mentorship/guidance to junior team members or cross-functional colleagues on study processes/study requirements
  
  

What We Seek

• BS/BA degree or AS degree in a health-related field
• 10+ years of clinical trial management experience, including CRO/vendor management (domestic and international), monitoring of budget and progressive clinical trial management experience across the full-cycle of drug development (Phase 1 through Phase 3)
• Participation in an NDA inspection and/or HA inspection is a plus
• Leadership excellence as a member of a cross-functional, global clinical trial team
• Collaboration, teamwork, and passion for excellence in clinical operations
• Demonstrated leadership in the management and monitoring of CRO and investigative sites
• Advanced experience with patient recruitment, non-compliance, safety, document management, investigational product, IP accountability, and budget management
• Broad knowledge of ICH, GCP, IRB/IEC and local regulatory authority drug research & development regulations
• Motivated to work in a fast-paced, high accountability environment
• Travel up to 25%
  
  

What We Provide To You

• The opportunity to make a difference in people’s lives impacted by autoimmune and inflammatory diseases.
• Participate in a team of life science professionals who value science, data, high work ethic and a meritocracy; access to all levels of the organization to get work done with a sense of urgency.
• Competitive compensation and a comprehensive benefit package, including stock options.
  
  

Ventyx is an equal opportunity employer and encourages potential or current employees to request a reasonable accommodation under federal, state and local regulations, should one be needed.

The anticipated annual base salary range for this role is $270,000 to $330,000. Final compensation depends on multiple factors including but not limited to, relevant experience, skillset, depth and breadth of knowledge, internal equity, company needs, and market factors. Ventyx is a rapidly growing biotech company that offers competitive wages and benefits package including medical, dental, vision, LTD, time off, a retirement plan, and other voluntary benefits for employees.

Notice To Recruiters And Agencies

The Human Resources team manages the recruitment and employment process for Ventyx Biosciences. To protect the interest of all parties involved, Ventyx Biosciences does not accept unsolicited referrals or resumes from any source other than directly from candidates. We will not consider unsolicited referrals and/or resumes from vendors including and without limitation, search firms, staffing or recruiting agencies or fee-based referral services. The submission of referrals or resumes by anyone other than a candidate directly to Ventyx Biosciences’ employees is strictly prohibited. Unsolicited referrals and resumes sent to Ventyx are deemed gratuitous, and do not obligate Ventyx to pay fees should we hire from those resumes. Recruiters are requested NOT to contact or present candidates directly to our hiring managers or employees. Please direct all inquiries to [email protected].