Director, Regulatory Affairs

San Carlos, CA, United States

Description

The Director, Regulatory Affairs will be responsible for providing global regulatory leadership in support of the development, registration, and lifecycle management of CARGO's oncology products. They will ensure effective achievement of regulatory/business objectives across teams, within the department, and at the corporate level. The Director will lead the development of regulatory strategy for products in various stages of development from IND to BLA, lead Health Authority interactions, and work closely with the cross-functional team to ensure delivery of high-quality documentation for regulatory submissions.

The role is based in San Carlos, CA.

WHAT YOU'LL DO AT CARGO THERAPEUTICS

The following is meant to be representative, but not necessarily all inclusive, of the duties and responsibilities for this position:

Develop and implement competitive and effective global regulatory strategies for oncology products focusing on Clinical and Nonclinical aspects, and identify potential risks associated with proposed strategies

Provide strong regulatory and scientific leadership to the cross-functional development teams to ensure that the development plan provides for optimal scientific positioning and highest regulatory probability of success

Lead the preparation, review and planning of submissions to regulatory agencies to support the conduct of clinical trials and approval of marketing applications, and is responsible for the maintenance of these applications (INDs, CTAs, BLAs, MAAs)

Ensure regulatory documents are developed with high quality, delivered in a timely manner, are consistent with corporate strategy, and are compliant with current global regulatory requirements

Serve as the primary point of contact with Regulatory Agencies and lead communication/meeting strategy development and execution

Facilitate preparation of briefing materials, responses to Health Authority questions, anticipate issues, and provide guidance to cross-functional teams on risk mitigation strategies

Work closely with Regulatory Writing and Regulatory Operations to develop submission plans and timelines

Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs

THE RIGHT STUFF: Required Experience & Qualifications Bachelor's degree, and 10-12 years of experience in the biopharmaceutical industry or equivalent, with a minimum of 8 years in Regulatory Affairs; advanced degree preferred

Thorough knowledge of US and international regulations as they apply to biologic development with the understanding of expedited approval pathways in oncology

Demonstrated experience managing INDs and CTAs

Experience with leadership of BLAs/MAAs from filing to approval

Considerable experience leading Regulatory Agency interactions (FDA meetings, EMA Scientific Advice, Advisory Committees, Oral Explanations, etc.)

Excellent technical and analytical skills with ability to make data-driven decisions

Strong written and oral communication skills

Strong leadership, negotiation, and collaboration skills

Proficient at creating and communicating a clear vision among team members, effectively aligning resources and activities to achieve organizational goals

Accountable for results and goal attainment

Experience with electronic submissions requirements

Ability to work independently with limited supervision, adapt to change, and manage multiple tasks

Ability to problem-solve and make decisions on complex issues, often in a cross-functional team setting

Prior experience in managing direct reports, including coaching and career development may be a plus

This position may require periodic travel (up to 10%) in the US

PAY RANGE

The pay range for this role is $194,000 - $266,000. Title and salary will be based on our assessment of skills and experience relevant to our needs for the role.

ABOUT CARGO THERAPEUTICS

CARGO Therapeutics, Inc. is a clinical-stage biotechnology company positioned to advance next generation, potentially curative cell therapies for cancer patients. CARGO's programs, platform technologies, and manufacturing strategy are designed to directly address the limitations of approved cell therapies, including limited durability of effect, safety concerns and unreliable supply. CARGO is currently evaluating its lead program, CRG-022, an autologous CD22 chimeric antigen receptor (CAR) T-cell therapy candidate, in a potentially pivotal Phase 2 clinical trial in patients with large B-cell lymphoma (LBCL) whose disease relapsed or was refractory (R/R) to CD19 CAR T-cell therapy. CARGO also plans to evaluate CRG-022 in patients at earlier stages of disease, including LBCL and other hematologic malignancies. Beyond its lead program, CARGO is leveraging its proprietary cell engineering platform technologies to develop a pipeline of programs that incorporate multiple transgene therapeutic "cargo" designed to enhance CAR T-cell persistence and trafficking to tumor lesions, as well as to help safeguard against tumor resistance and T-cell exhaustion. CARGO's founders are pioneers and world-class experts in CAR T-cell therapy, and its team has significant experience and success developing, manufacturing, launching and commercializing oncology and cell therapy products. For more information, please visit the CARGO Therapeutics website at https://cargo-tx.com/.

Join us to help make a difference!

EEO & EMPLOYMENT ELIGIBILITY

CARGO Therapeutics, Inc. is committed to building a diverse, equitable, and inclusive company. We provide equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, or veteran status. CARGO Therapeutics, Inc. also complies with all applicable national, state, and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification required of applicable law.

CARGO Therapeutics requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at CARGO Therapeutics, and it applies regardless of whether the position is located at a CARGO Therapeutics site or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited because of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.