Vice President, Head of Clinical Development

About the job

At Syncopation Life Sciences, upending the status quo is in our DNA. We combine a deep understanding of CAR T resistance with a vision of transforming peoples’ lives through the development of next generation cell therapies that provide deeper and more durable responses to a growing number of patients.

Syncopation is an exciting biotechnology company founded by Crystal Mackall and Robbie Majzner to develop next generation CAR T cell therapies designed to achieve superior efficacy by pre-empting important drivers of drug resistance. Our lead program includes a differentiated and clinically validated CD22 CAR that is in clinical development for patients with B-cell malignancies. To help move this and other programs forward, Syncopation has brought together a passionate and seasoned team to develop a focused portfolio strategy. Our team is based in San Mateo, California.

Join us to help make a difference.

Position Summary

Syncopation is hiring a Vice President, Head of Clinical Development to grow a growing clinical development function to support our cell therapy portfolio. The successful candidate will work closely with the chief medical officer and the rest of the executive team to provide strategic direction and technical leadership to the clinical development team including clinical-regulatory development planning, clinical trial design, implementation and execution, clinical data analysis and management, and clinical competitive intelligence. This individual will provide strategic leadership for the clinical and medical aspects and will work closely with a cross-functional team to align the clinical development plan with the overall development strategy of the relevant products. The role is responsible for overseeing trials in clinical development according to established timelines, for establishing and maintaining close working relationships with internal and external partners, and for providing the clinical regulatory landscape for each of the clinical programs. The Vice President, Head of Clinical Development will act as a cross functional advisor and will work closely with the internal and/or external Clinical Development, Pharmacovigilance, Biometrics, Clinical Operations, Research, Regulatory, Biomarkers, Medical Affairs and the Commercial teams to execute clinical trial strategy and design.

The roles is based in San Mateo, CA but is also suitable for a hybrid or remote work arrangement.

What You’ll Do at Syncopation

The Vice President, Head of Clinical Development will lead a group of clinical development professionals who develop, implement, and execute across the following broad areas of responsibility:

  • Responsible for the overall development strategy of the clinical development programs that will lead to global regulatory approval
  • Provide medical and scientific expertise in clinical development and regulatory filing activities and participate in FDA/EMA meetings to support clinical development aspects
  • Responsible for guiding the clinical development team on the preparation of global clinical development plans, providing medical input to IBs, study protocols, study reports, regulatory briefing packages and the clinical sections of INDs, NDAs, annual reports, and Developmental Safety Update Reports.
  • Oversee safety and medical monitoring for clinical studies (e.g., SAE reporting, ongoing review of events, integrated evaluation)
  • Function as the medical expert on one or more clinical development programs
  • Plan and participate in data analysis and creation of key study-related outputs such as clinical study reports and publications
  • Oversee and serve where required on Joint Development and/or Steering Committees with partners
  • Develop and maintain relationships with external stakeholders such as key opinion leaders and site investigators
  • Build, train, and mentor the clinical development team as the company scales

The Right Stuff

M.D. (or equivalent) degree required. Training and board-certification/eligibility in hematology/oncology strongly desired; candidates who are not specialty trained should have demonstrated clinical development experience and proficiency in cell therapy/malignant hematology

  • Minimum 10 years of clinical development experience in a biopharmaceutical or pharmaceutical company including leading late-stage clinical trials, regulatory filings, and product launches. Experience with cell therapy or bone marrow transplant is a plus.
  • At least 5 years of direct management
  • Extensive regulatory experience with gaining approvals of NDAs, MAAs, BLAs. Experience with breakthrough designation, RMAT, Sakigake, PRIME, orphan designation and companion diagnostic submissions (IDE/PMA) is highly desirable
  • Executive leadership skills to educate and influence stakeholders and to add value to strategic business planning and decision-making
  • Ability to lead, influence, and drive a cross functional team by using a collaborative approach
  • Demonstrated ability to establish relationships with internal colleagues and external collaborators (g., investigators, KOLs/CROs) and represent the company in public (e.g., scientific conferences, partners)
  • Experience with GCP/ICH/FDA requirements, clinical trial design and strategies, commercial and publication strategy and medical information process
  • Outstanding clinical and business judgment required
  • Must employ science-and data-driven decision making
  • Must have a results-oriented work ethic and a positive, can-do attitude
  • The ideal candidate will be capable working in a “hands on” and “roll-up sleeves” capacity when required or providing oversight and guidance depending on the circumstances
  • Proven experience in building a high performing team. You can recruit and develop top talent, motivate and empower a team, work cross-functionally, and delegate effectively.
  • Must be willing and available for periodic travel including domestic US and internationally as required.

EEO & Employment Eligibility

Syncopation Life Sciences, 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. Syncopation Life Sciences, Inc. also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requires of applicable law.

Syncopation Life Sciences requires all new hires to be fully vaccinated against COVID-19 as of their start date.  This requirement is a condition of employment at Syncopation, and it applies regardless of whether the position is located at a Syncopation 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 as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.