Vice President, Regulatory Affairs

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, Regulatory Affairs to grow a global regulatory affairs function for our cell therapy portfolio. The Vice President is responsible for regulatory affairs strategy for multiple cell therapy products spanning from early clinical development through commercialization and will also oversee any regulatory affairs activities related to companion diagnostics. We are looking for a candidate that is experienced in innovative drug development within a global environment. This is a critical position that will play a key role in establishing and maintaining effective relationships with global health authorities, and cross-functional partners.

The successful candidate will work closely with the chief medical officer, the chief technical officer and the rest of the executive team to develop the long term global regulatory strategy and vision for Syncopation cell therapy products. This includes leading interactions with health authorities, leading and contributing to submission management activities, and creating fit for purpose regulatory function processes including appropriate build out of the regulatory team.

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

What You’ll Do at Syncopation

The Vice President, Regulatory Affairs will lead a group of regulatory professionals who develop, implement, and execute across the following broad areas of responsibility:

  • Set strategy, direct, plan and implement all regulatory activities required to initiate and conduct clinical trials and to seek marketing authorization
  • Interact with the FDA, EMA, and other regulatory agencies to seek scientific and regulatory advice and obtain required approvals
  • Provide strong cross-functional leadership for global filings including reviewing sections of IND/CTA, NDA/BLA/MAA, and other global submission documents in support of clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements.
  • Build the regulatory function and maintain strong leadership capabilities at all levels within the regulatory team and support the professional development of regulatory team members. Developing and implementing cross site department policies, processes and SOPs.
  • Ensure the successful on time delivery of high-quality submissions to global regulatory health authorities in alignment with both Syncopation and health authority standards.
  • Provides regulatory leadership for due diligence activities, partnering activities, and product/company integrations
  • Oversee the development and implementation of innovative systems, tools and streamlined processes to create and maintain high-quality regulatory submissions and manage a state-of-the-art regulatory intelligence and knowledge management approach.
  • Responsible for continuous improvement of systems and processes, including internal training, for the regulatory department and cross functional teams
  • Ensure inspection readiness efforts for regulatory activities and files
  • Manage regulatory budgets and vendors
  • Maintain current expertise in regulatory trends and operations
  • Participate as needed in technical discussions and collaborate with corresponding groups at Health Authorities to advance Regulatory Science

The Right Stuff

Preferred Qualifications:
Graduate degree required, PhD, MD or Pharm D. degree preferred.

  • Minimum 10-15 years in biotech/pharma industry with 5+ years of managerial experience leading, coaching and developing a team of people at the manager level or above.
  • Extensive regulatory experience with gaining approvals of NDAs, MAAs, BLAs and/or sBLAs. Experience with breakthrough designation, RMAT, Sakigake, PRIME, orphan designation and companion diagnostic submissions (IDE/PMA) is highly desirable
  • Experience with cell and gene therapy products/ complex biological products
  • Experience with hematology/oncology products and interacting with CBER
  • Experience in leading multidisciplinary teams
  • Relevant knowledge in CMC, clinical and nonclinical science
  • Knowledge expert regarding global regulatory submission standards and publishing best practices.
  • Knowledge expert regarding FDA regulations, ICH and global cell therapy product development guidelines
  • Experience with process design and improvement and with developing systems from the ground up.
  • Ability and interest in rolling up their sleeves to perform hands-on regulatory activities while simultaneously building the department to ensure successful scalability as the programs grow
  • Demonstrated proficiencies in leading successful health meetings and interactions
  • Ability to influence without direct authority
  • Independently motivated, excel at driving execution, detail oriented
  • Strong written and verbal communication skills
  • Understanding of clinical operations with the ability to implement well-designed experiments within a clinical trial environment
  • 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 because of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.