Director/Associate Director, 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: Director/Associate Director, Clinical Operations

The Director/Associate Director, Clinical Operations will ensure that clinical strategies and study protocols are translated into operational plans for assigned studies. Works closely with Clinical Development, within the Clinical Operations teams, and with all involved functions to ensure high quality deliverables. This role may be responsible for a global study or oversee study managers within an indication.

What You Will Contribute

• Interacts with and participates in 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 support the execution of clinical trials.
• Participates in the development and review of the protocol and informed consent to provides an operational feasibility perspective and confirm clarity of procedures.
• Demonstrates leadership in the planning, execution, and completion of clinical trials – on-time, on-budget and adhering to all regulatory and patient safety requirements.
• Drives the review and 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.
• Oversees study budget, investigator and vendor contracts, budgets, and payments; reviews accruals on a regular basis.
• 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.
• Develops and drives aggressive recruitment strategies, and ensures CRO is executing the agreed upon strategy.
• Develops and delivers presentations as needed.
• Participates in the selection and oversight of Contract Research Organizations (CROs) and vendors.
• May have functional reporting responsibilities or indirect reports (e.g., study team members).
• Supports audit/inspection activities as needed.
• Maintains clinical trial registry entry/updates, as required.
• Provides mentorship/guidance to less experienced team members or cross-functional colleagues on study processes/study requirements.
• Remains current on pharmaceutical regulations, guidelines, and practices and therapeutic area knowledge and ensures consistent best practice across all activities.
• Maintains knowledge of ICH-GCP, external regulations and procedures.
  
  

What We Seek

• BS/BA degree or AS Degree in a health-related field (e.g., RN) 8+ 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).
• 8+ years’ experience in the described contributions.
• 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.
• Demonstrated agility to learn, and prioritize multiple responsibilities independently, remove barriers and drive projects to completion.
• Strong oral & written scientific communications skills.
• Good presentation skills for diverse audiences (investigator meetings, site personnel, KOL interactions and internal project teams).
• Ability to strike a balance between independent work and team interaction, be a team player in a cross-functional team.
• Well-developed interpersonal skills, with experience in interacting with and influencing people, building strong positive relationships.
• Proficiency in Microsoft Office and other productivity tools with an aptitude to learn new software and systems; ability to work with large databases.
• Ability to 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 $150,000 to $240,000. 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 careers@ventyxbio.com.