Treadwell Therapeutics is a private, clinical-stage oncology company with a presence in the US, Canada, and Hong Kong. The company’s vision is to create a multi-modality, multi-asset and multi-national biotechnology organization developing first-in-class and best-in-class medicines to address unmet needs for cancer patients. We are currently developing three lead clinical stage small molecule candidates with first in class mechanisms and early signs of clinical utility while advancing several undisclosed antibody programs that are showing compelling pre-clinical efficacy. In addition, Treadwell is using a proprietary discovery platform to identify TCRs to address both solid and liquid tumors with significant unmet needs using autologous T cell therapy. We are looking for enthusiastic and dynamic individuals who share our passion for science.
Job Summary
Reporting to the Chief Medical Officer, the Vice President, Regulatory Affairs will be responsible for developing and driving the execution of overall regulatory strategy, providing leadership and oversight on all submission activities, and building a high functioning team at Treadwell. This is a fantastic opportunity to join a small team, work on transformative science, and take part in building an exciting, science-driven global company.
Key Accountabilities
- Shape, create alignment, and execute the regulatory strategy in collaboration with the executive leadership team.
- Provide therapeutic area regulatory strategies and disease state insights; regulatory visions and direction to add patient value and product differentiation; and recommendations to optimize our portfolio.
- Serve as a primary liaison with health authorities and FDA; establish appropriate, proactive communication with agency officials to assure expedient and efficient review and approval of submissions; chair meetings between company and FDA and prepare internal teams for meetings with FDA at any phase of drug development.
- Provide strategic and technical guidance on critical impact regulatory submissions, due diligences for potential out-licensing activities and external collaborations.
- Provide regulatory guidance to executive leadership and project teams in all areas of regulatory affairs throughout the research and development process, approval, and post approval phases.
- Develop and communicate project scheduled for regulatory filings; plan and oversee all activities in support of INDs, NDAs, CTAs, BLAs, and other regulatory submissions.
- Coordinate the preparation, submission and follow-up contact with regulatory agencies for all applications and submissions. Provide regulatory review and final approval for all submissions and associated documentation.
- Participate in regulatory and CMC due diligence activities for licensing candidates in collaboration with business development group.
- Play a lead role in updating and preparing the company for major changes in legislation which impact across functions.
- Ability to travel as needed.
Education, Experience, Competencies
- A Bachelor of Science degree, Master of Science or higher preferred.
- Minimum 15+ years of relevant regulatory leadership experience in biotech and pharmaceutical industry, oncology drug development program experience is a big plus.
- Proven track record of success in supporting successful Phase I-III clinical trials and progressing programs including INDs, early and late-stage development plans to completion with FDA
- Experience with small molecules through approval is preferred
- Experience building teams and establishing regulatory capabilities and functions
- Experience in Asia required
- Demonstrated ability to develop and maintain excellent working relationships with US FDA and similar key international regulatory agencies including the planning/ implementation of agency meetings.
- Experience with CTD format and content for regulatory filings (e.g., INDs, CTAs, NDAs/BLAs).
- Excellent interpersonal communication and presentation skills to facilitate collaboration across functions and building successful relationships with internal and external stakeholders as well as external parties.
- Experience managing complex schedules and shifting priorities in a dynamic environment.
- Ability to dissect complex issues to quickly distill key issues for discussion with regulatory authorities and guide teams in the preparation of response to regulatory questions.
- Entrepreneurial thinker and attitude, highly creative and comfortable with hands on startup culture
Treadwell anticipates that the base salary range for the Vice President, Regulatory Affairs working remotely within U.S. is $280,000 - $350,000. Please note that at the Company’s sole discretion, the final compensation for this position will depend on the successful candidate’s geographic location and qualifications for the role including job level, education, skill level, and years of relevant work experience. The compensation range described above is subject to change based on market survey data at the time of hiring. This position will also be eligible for an annual discretionary performance bonus and equity incentive plan. In addition, at Treadwell, we value our employees and their well-being, therefore, we offer comprehensive package of benefits including 100% company-paid health insurance, 401(k) with employer matching program, and generous paid time off in addition to company holidays and winter shutdown.
Given the nature of our business this is primarily a hybrid role. Full vaccination for COVID is a requirement for this position. Applicants may request a reasonable accommodation based on disability and/or religion reasons. Treadwell reserves the right to deny such requests when appropriate.
