Interested in bringing the promise of cell therapy to life for patients with cancer?

We’re seeking exceptional candidates who are passionate about changing the course of history for patients with cancer.

If that’s you, consider applying for our current openings. If there are currently no roles open, please feel free to email your interest to:

Vice President of Clinical Regulatory Affairs

Role Overview

Chimeric Therapeutics is a clinical stage cell therapy company focused on bringing the promise of cell therapy to life for more patients with cancer. We believe that cellular immunotherapies may be able to cure cancer, and not just delay its progression.  To bring that promise to life for more patients, Chimeric’s world class team of cell therapy experts is focused on the discovery, development, and commercialization of innovative cell therapies.

The Vice President of Clinical Regulatory Affairs reports to the Chief Medical Officer. The successful candidate will work closely with internal and external collaborators to shape and deliver on the regulatory strategy of Chimeric’s Clinical Programs while maintaining alignment with corporate and clinical timelines. These activities include leading interactions with health authorities, leading and contributing to submission management activities, and developing Chimeric’s regulatory function processes including appropriate build-out of the regulatory team.  The qualified candidate will have the regulatory expertise and knowledge necessary to advance Chimeric’s candidates from first-in-human clinical trials through global marketing authorizations and beyond.

Key Responsibilities – The successful candidate:
  • Is a key member of Chimeric Project Teams and regulatory subject matter expert engaging with cross-functional team members to deliver on the promise of Chimeric’s product candidates.
  • Works closely with the executive leadership team to develop and execute on regulatory plans that result in the successful registration and post-approval commercialization of Chimeric’s product candidates
  • Provides strategic and tactical direction to drive cross-discipline consistency in regulatory approach and planning.
  • Serves as primary regulatory agency contact (at the FDA and at other agencies) to achieve Chimeric’s regulatory objectives, by fostering strong relationships and acting as a credible, reputable, and effective advocate for our programs.
  • Serves as key point of contact for managing and directing regulatory inspections.
  • Develops and executes on strategies for ex-US marketing authorizations of Chimeric’s product candidates.
  • Develops and implements robust regulatory structures, processes, and procedures.
  • Provides guidance and critical evaluation of potential business development opportunities.
  • Provides regulatory review and approval of product labeling, promotional claims, and advertising to ensure compliance with corporate policy, and US and international laws and regulations.
  • Directs long and short-term departmental planning including structure, headcount, budgeting, training, and systems requirements.
  • Manages internal regulatory procedures to ensure compliance.
  • Manages external regulatory vendor and platform service team members and providers.
  • Hires, onboards, and manages regulatory professionals.
Professional Experience/Qualifications

Candidates for this position should hold the following qualifications, have the following experience, and be able to demonstrate the following abilities to be considered as a suitable applicant. Please note that except where specified as “preferred,” all points listed below are considered minimum requirements.

Performs responsibilities competently and with limited guidance.

  • Makes decisions based on impeccable ethics.
  • Demonstrates outstanding attention to detail.
  • Prioritizes multiple tasks and goals and delivers high-quality results on time, on-target and within budget guidance.
  • Communicates effectively:
    • Influences without authority and has proven experience building and cultivating relationships with key partners and stakeholders, both internally and externally.
    • Presents information and key considerations clearly and succinctly.
    • Interacts confidently and competently with internal/external stakeholders
    • Negotiates and works effectively with others internally and externally to drive toward desired results.
  • Approaches cross-functional problem-solving thoughtfully to effectively identify and address important factors affecting regulatory strategies.
  • Able to travel within North America (<25%.)
Education and Experience
  • Advanced clinical/science degree required (MD, PharmD, PhD, MSN, MPH, etc.).
  • Minimum 10 years in pharmaceutical / biopharmaceutical industry (ideally both small and large companies)
  • Extensive regulatory management experience and in developing innovative regulatory solutions.
  • Track record of success in gaining approval of original NDAs, MAAs and / or BLAs
  • Experience with cell and gene therapy products/ complex biological products
  • Experience with oncology products
  • Relevant knowledge in CMC, clinical and nonclinical science
  • Knowledge expert in global regulatory submission standards and publishing best practices.
  • Knowledge expert in global cell therapy product development guidelines