This company is a public, clinical-stage biopharmaceutical company that harnesses the immune system to target and eradicate cancer cells. The company is developing the first of its kind allogeneic approach for CAR-T immunotherapies in oncology, pioneering the concept of off-the-shelf and ready-to-use gene-edited CAR T-cells to treat cancer patients.

As a clinical-stage biopharmaceutical company with over 21 years of expertise in gene editing, this company is developing life-changing product candidates utilizing its gene editing technology and its pioneering electroporation system to harness the power of the immune system in order to target and eradicate cancer cells.

As part of its commitment to a cure, this company remains dedicated to its goal of providing lifesaving therapeutic candidates to address unmet needs for multiple cancers including acute myeloid leukemia (AML), B-cell acute lymphoblastic leukemia (B-ALL), multiple myeloma (MM), Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL). The company currently has 8 clinical trials ongoing, 8+ preclinical programs (sponsored by the company or by its licensees), 278 granted patents and $4B of disclosed potential milestones through strong partnerships for cell therapy and gene editing development.

With their headquarters in Paris, France and additional locations in New York, NY and Raleigh, NC, innovative platform, promising pipeline, experienced Board, and seasoned team, the company is well-positioned to continue its trajectory as an innovative and leading, next generation biopharmaceutical company.

The company is seeking a Head of US Regulatory Affairs, who will be responsible for leading and implementing strategic and operational regulatory activities for their portfolio which includes assets ranging from pre-clinical to clinical-stage assets. They will report to the Chief Regulatory Officer and be responsible for the US regulatory strategy for the development of all compounds, including current and future indications. They will also play an important role in maintaining effective communication and constructive working relationships with both internal and external collaborators including regulatory authorities in the US.

These activities include acting as the regulatory representative, and/or overseeing reports acting as such, on core teams, developing and planning regulatory submission strategy, coordinating the preparation of submissions to regulatory agencies, and conducting regulatory intelligence activities. The Head of US Regulatory will work closely with key leaders throughout the organization in order to interact with regulatory agencies and ensure the timely preparation of scientifically valid submissions. The company currently has a 4-day in-office work requirement, this role will report into the Manhattan office.

Areas of specific responsibility include the following:

The Head of US Regulatory Affairs is a key role and will be a major contributor in shaping the future success of the company. As such, the successful candidate will have a strong work ethic, be an entrepreneurial self-starter, and be highly productive in a dynamic, collaborative environment.

This position offers broad exposure to all aspects of the company’s business as well as significant interaction with all business leaders.

Requirements will include:

Undergraduate degree required. The ideal candidate will possess an advanced degree in finance and/or science or medicine.

The compensation package will be designed to include a competitive base salary, bonus structure and equity participation.

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Korn Ferry shall provide equal employment opportunity to all qualified candidates, and will refer candidates without regard to race, color, religion, national origin, sex, age, disability, veteran status or any other legally protected basis.