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VP, Regulatory Affairs

Company: Theseus Pharmaceuticals
Location: Cambridge
Posted on: May 12, 2022

Job Description:

Theseus Pharmaceuticals is passionately committed to improving the lives of cancer patients by working to outsmart cancer resistance. Led by a team of targeted oncology pioneers with a proven track record developing and commercializing cancer therapeutics, we are developing the next generation of tyrosine kinase inhibitors (TKIs): "pan-variant" targeted therapies that address all known drug-resistant mutations. We believe a pan-variant approach is the only way to address cancer resistance. Our lead program, THE-630, is a pan-variant KIT inhibitor for patients with advanced gastrointestinal stromal tumors (GIST), whose cancer has developed resistance to earlier lines of kinase inhibitor therapy. We are also developing a fourth-generation, selective epidermal growth factor receptor (EGFR) inhibitor to address C797S-mediated resistance to first- or later-line osimertinib treatment in patients with non-small cell lung cancer (NSCLC). For more information, visit theseusrx.com . Role: Vice President, Regulatory Affairs Overview: Reporting to the Chief Medical Officer, the Vice President and Head of Regulatory Affairs will develop, lead and drive the execution of the Theseus's regulatory strategy from pre-IND through regulatory approval to launch, commercialization and product lifecycle management. This person will be the senior lead for all Regulatory functions at Theseus, with responsibility for regulatory strategy, filings, communications, and negotiations for the company and have ultimate accountability for developing and executing global regulatory strategies aimed at the most efficient pathway for Theseus's oncology drug development programs. Who are we looking for?

  • You are an energetic and passionate Regulatory Affairs professional who likes to think outside of the box, challenge the norm, and is passionate about the company's mission of discovering and developing new medications
  • You are a resourceful self-starter and team player with a strong results orientation
  • You can develop trusting relationships to gain support and achieve results at all levels of the organization What are we looking for?
    • A driven and strategically minded professional who knows how to work and contribute to an ever-changing working environment
    • A collegial individual who enjoys working in close collaboration with leaders in the research, development, manufacturing, quality, clinical and administrative areas of the company
    • A willingness to learn new things, adapt to new ways and go with the flow
    • A person who thrives in a small company atmosphere
    • Ability to determine task priority and maintain established deadlines What are we offering?
      • Membership within a growing, CARING and collegial organization devoted to making a positive impact on the lives of cancer patients
      • Being key part of passionate, involved, and cutting-edge drug development team
      • The opportunity to significantly influence the direction of our product development by employing a strategic approach to Regulatory Affairs and developing strong cross-functional relationships and processes within the broader development organization What you will do:
        • Build and lead the Regulatory function
        • Responsible for directing innovative global regulatory strategies for product development and approval.
        • Plan and oversee activities in support of INDs, NDAs, MAAs, CTAs and other regulatory submissions.
        • Serve as the company contact with major health authorities and liaise directly with FDA and other regulatory agencies, including the preparation and leading of agency meetings.
        • Provide regulatory guidance to company personnel, project teams, and subcommittees in all areas of regulatory affairs throughout the research and development process, approval and post approval phases.
        • Develop and monitor product regulatory plans including oversight of implementation of the project plan, decision making on issues that could delay project schedules or activities, communicating issues/risks to key stakeholders in a timely and consistent manner, providing input on budget requirements, and monitoring both functional and project performance against goals.
        • Direct and assist internal staff and consultants, as required, to ensure the compliance of Theseus's drug development activities with all U.S. and international requirements.
        • Use sound judgement and provide regulatory guidance and design for support of product development and registration strategies, including broad regulatory oversight for program development.
        • Hire, manage, and develop the Regulatory team.
        • Provide support, mentorship and guidance to Regulatory Affairs to ensure staff can independently make sound strategic and tactical decisions.
        • Perform all duties in keeping with the Company's core values, policies, and all applicable regulations. What you will bring:
          • A Bachelor of Science degree, preferably in a life science field. Masters of Science or higher preferred.
          • 12+ years of regulatory strategy, managing programs in the pharmaceutical industry, including 3+ years on oncology drug development programs.
          • Knowledge and broad experience with regulatory procedures and regulations in multiple regions, including the US, EU, and other major health authorities.
          • Significant experience leading face-to-face interactions and other formal interactions with FDA and other health authorities. Experience with Oncology division of FDA.
          • Regulatory leadership and team management experience.
          • Experience with CTD format and content for regulatory filings (e.g. INDs, CTAs, NDAs/BLAs, MAAs).
          • Demonstrated track record in successfully progressing programs including INDs, early and late-stage development plans to completion, and in securing product approvals with successful NDAs/BLAs and/or MAAs.
          • Experience with Expedited Programs such as FastTrack, Breakthrough Therapy Designation, PRIME.
          • Experience managing complex schedules and priorities in a dynamic environment; ability to adapt to shifting priorities, demands and timelines through excellent analytical and problem-solving capabilities.
          • Strong scientific acumen and eagerness to learn.
          • Ability to communicate effectively orally and in writing, both internally and with external vendors and partners.
          • Familiarity with e-publishing systems for preparing regulatory submissions
          • Familiarity with GCP, GMP and GLP. Our values: Transparency: We work with honesty, openness, and integrity. Community: We collaborate and thrive together. Patient-Focused: We are committed to finding new medicines for patients. Resolve: We never give up on our mission. When You Join Theseus Pharmaceuticals You Will Have:
            • Location reachable by public transportation (Red Line)
            • Customized and competitive health coverage, including medical offered through BCBS (HMO/PPO), dental, and vision
            • Health Savings Account for medical expenses
            • Eligible from the first day for 401K with 100% match of the first 5%
            • A robust package of Theseus-paid insurance coverage, including life insurance, short-term and long-term disability
            • Unlimited time off and 11 Holidays
            • Winter Break: Theseus is closed for a Winter Break between Christmas and New Year Location: Cambridge (Kendall Square), MA Candidates should be aware that Theseus Pharmaceuticals requires all employees to be fully vaccinated against COVID-19. Newly hired employees must be vaccinated prior to their employment start date. Theseus is an equal opportunity employer and will provide reasonable accommodation to those unable to be vaccinated where it is not an undue hardship to the company to do so as provided under federal, state, and local law. Theseus Pharmaceuticals is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. TO ALL AGENCIES: Please, no phone calls or emails to any employee of Theseus about our openings. All resumes submitted by search firms/employment agencies to any employee at Theseus via email, the internet or in any form and/or method will be deemed the sole property of Theseus unless such search firms/employment agencies were engaged by Theseus for this position and a valid agreement with Theseus is in place. In the event a candidate who was submitted outside of the Theseus agency engagement process is hired, no fee or payment of any kind will be paid.

Keywords: Theseus Pharmaceuticals, Cambridge , VP, Regulatory Affairs, Other , Cambridge, Massachusetts

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