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Vice President/Senior Vice President, Regulatory Affairs

2 months ago

San Diego, United States VENTYX BIOSCIENCES, INC. Full time

Description

Ventyx Biosciences, Inc. (Ventyx) is a clinical-stage biopharmaceutical company focused on advancing novel oral therapies that address a broad range of inflammatory diseases with significant unmet medical need. We are developing novel and differentiated therapeutics that target both the innate and adaptive immune system. Our clinical-stage pipeline includes Phase 2-ready, peripheral and CNS inhibitors of the NLRP3 inflammasome, a Phase 3-ready, S1P1 receptor modulator for the treatment of ulcerative colitis, and an allosteric TYK2 inhibitor completing a Phase 2 study for the treatment of Crohns disease. Join this talented team of life science professionals to bring these programs to fruition.

The Opportunity:

The Vice President or Senior Vice President, Regulatory Affairs (RA) will be responsible for all aspects of Regulatory Affairs for this growing biotech company. The role will offer leadership opportunities for the VP/SVP to build and lead a high performing, global regulatory function for Ventyx. This position reports to the Chief Medical Officer.

What You Will Contribute:

  • Breadth and depth of regulatory expertise and leadership across multiple, cross-functional product development teams.
  • Primary RA representative on multiple global studies.
  • Oversee, coordinate and ensure all RA deliverables (including regulatory submissions) for each development program are completed on time and on budget, while meeting relevant regulatory and company guidelines.
  • Analyze data, the regulatory environment, and business objectives to drive alignment on priorities.
  • Direct, train, and guide internal teams on interactions with regulatory authorities.
  • Develop and drive regulatory risk management and contingency plans and communicate plans to the executive team, broader management team and board of directors.
  • Provide strategic direction on current pharmaceutical regulations, guidelines, and practices while ensuring best practice across all activities.
  • Additional duties assigned as needed.

What We Seek:

  • 15+ years of years relevant experience in RA and/or related functions in drug development showing progressive leadership development.
  • BS/BA degree in life sciences discipline or highly related field required, Ph.D. or advanced degree preferred.
  • Demonstrated experience in leading the RA function.
  • Broad understanding of international regulations, processes, and issues in drug development.
  • Experience as a regulatory leader for IND/CTA, NDA/MAA filings.
  • Confident and competent when interacting with varying levels of internal/external stakeholders, raising issues or challenges in a constructive and mature manner, and building strong positive relationships.
  • Strong negotiation skills: can effectively drive discussions and decisions toward desired results.
  • Strong writing skills with high attention to detail.
  • Excellent project management skills: can prioritize multiple tasks and objectives to consistently deliver against corporate goals and timelines.
  • Strong interpersonal and communication skills: can influence stakeholders and has proven experience building and cultivating relationships with key partners at various levels, both internally and externally.
  • Proven track record of effective decision-making, exercising sound judgement and acting with integrity and strong ethics.
  • Broad and current knowledge of ICH, GCP, IRB/IEC guidelines and local regulatory authority regulations and applicable law
  • Motivated to work in a fast-paced, high-accountability environment.
  • Demonstrated ability to learn, and prioritize multiple responsibilities independently, remove barriers and drive projects to completion.
  • Ability to strike a balance between independent work and team interaction (strong individual contributor and key, senior member of cross-functional teams.
  • Proficiency in Microsoft Office and other productivity tools with an aptitude to learn new software and systems.

What We Provide to You:

  • The opportunity to make a difference in peoples 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 reasonable accommodation under federal, state and local regulations, should one be needed. The anticipated base salary range for this position is $280,000 to $360,000 per year. 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, Inc. To protect the interest of all parties involved, Ventyx 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 Ventyxs 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.

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