VP, Regulatory Affairs
Company: Theseus Pharmaceuticals
Posted on: May 12, 2022
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
- 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
- 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
- Being key part of passionate, involved, and cutting-edge drug
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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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