Director/Senior Director, Clinical Regulatory Affairs

Company Description:

Synthekine is a Menlo Park, CA based clinical stage biotechnology company focused on discovering and developing best-in-class cytokine therapeutics to treat cancer and autoimmunity. We use our unique insights on how cytokines bind to their receptors and tune these systems through protein engineering to generate therapeutics that have transformative potential. Synthekine is currently advancing a novel IL-2 partial agonist into Phase 2 and Phase 3 studies in lung cancer. Come join us and help us give patients and physicians better options to treat disease and advance cytokine science along the way.

Position Summary:

The Director/Senior Director, Clinical Regulatory Affairs will serve as the clinical regulatory lead for assigned programs across oncology integrating scientific, medical, clinical, and regulatory perspectives to advance innovative therapies from clinical development through registration and commercialization.

This role requires deep regulatory expertise in oncology, sound judgment, attention to detail, and the ability to operate as both a strategic leader and hands-on contributor in a fast-paced biotechnology environment. The successful candidate will lead global regulatory strategy, health-authority interactions, and clinical-development submissions while partnering closely with internal teams and external development partners across regions.

Level will be determined based on the candidate’s regulatory leadership experience, oncology expertise, global health-authority engagement, and experience with BLA/MAA filings and product-label negotiations.

Responsibilities:

  • Serve as the clinical regulatory lead for assigned oncology programs and represent Regulatory Affairs on cross-functional development, study, and governance teams.
  • Develop and execute global clinical regulatory strategies that support efficient development, registration, and commercialization.
  • Lead interactions with the FDA, EMA, and other global health authorities, including meeting requests, scientific advice and pre-submission meetings, briefing documents, internal rehearsals, meeting participation, minutes, and follow-up activities.
  • Manage health-authority questions, requests, commitments, and conditions, working with subject-matter experts to develop clear, scientifically robust responses.
  • Lead the preparation, submission, and maintenance of global clinical regulatory filings, including INDs, CTAs, amendments, DSURs and annual reports, investigator’s brochures, and agency responses.
  • Lead expedited-pathway and designation strategy, including Fast Track, Breakthrough Therapy, RMAT, Orphan Drug and Rare Pediatric Disease designations, PRIME, and Project Orbis, and assess accelerated-approval opportunities for assigned programs as needed.
  • Own the pediatric regulatory strategy for assigned programs, including the FDA initial Pediatric Study Plan, the EU Paediatric Investigation Plan, and obligations arising under the RACE for Children Act.
  • Provide regulatory leadership on dose selection and optimization consistent with FDA Project Optimus, and on biomarker-defined patient selection, including companion- or complementary-diagnostic co-development strategy where applicable.
  • Provide regulatory review of and input into clinical protocols, informed consent forms, statistical analysis plans, and clinical study reports.
  • Identify regulatory risks and opportunities, informed by regulatory intelligence and competitor precedent, recommend practical solutions, and communicate implications clearly to program and senior leadership.
  • Partner closely with Clinical Development, Clinical Operations, Biostatistics, Pharmacovigilance, Clinical Pharmacology, Translational Medicine, Nonclinical, CMC, Quality, and Regulatory Operations.
  • Coordinate effectively with external development partners, consultants, and regional regulatory teams.

Qualifications

  • Advanced scientific, medical, or pharmacy degree, such as a PhD, PharmD, MD, or equivalent. Candidates holding a bachelor’s or master’s degree with commensurate depth of regulatory leadership experience will also be considered.
  • At least 10 years of pharmaceutical or biotechnology industry experience, including a minimum of five years developing and executing global regulatory strategies. Greater depth of experience and leadership scope will be expected at the Senior Director level.
  • Substantial experience in oncology drug development and demonstrated ability to lead regulatory strategy for clinical-stage programs.
  • Direct experience preparing for and leading interactions with the FDA and other global health authorities.
  • Experience preparing and managing INDs, CTAs, amendments, agency responses, DSURs and annual reports, investigator’s brochures, and related global submissions.
  • BLA and/or MAA filing experience, including product-label negotiations, strongly preferred for Senior Director candidates.
  • Demonstrated experience securing expedited-program designations (Fast Track, Breakthrough Therapy, Orphan Drug, PRIME) and negotiating registrational-intent or accelerated-approval designs with health authorities.
  • Working knowledge of pediatric regulatory requirements in the US and EU, including preparation and negotiation of iPSPs and PIPs.
  • Familiarity with biomarker-driven development and companion-diagnostic co-development requirements is an advantage.
  • Experience supporting development programs across multiple geographic regions is highly desirable.
  • Deep knowledge of FDA, EMA, ICH, and international regulatory requirements, guidance, drug-development processes, and industry practices.
  • Strong scientific and clinical judgment, with the ability to translate complex data into clear regulatory recommendations.
  • Exceptional written, verbal, interpersonal, and presentation skills.

Leadership Attributes

  • Operates effectively as a player/coach, moving between strategic leadership and detailed execution.
  • Maintains rigorous attention to detail while keeping broader program and corporate objectives in view.
  • Demonstrates strong judgment, leadership presence, and the ability to influence without formal authority.
  • Builds alignment across internal functions, partner companies, consultants, and regional teams.
  • Anticipates issues, manages competing priorities, and delivers high-quality work under demanding timelines.
  • Is intellectually curious, adaptable, collaborative, and motivated to grow with the organization.

Level Considerations

  • Director: Independently leads regulatory strategy, submissions, and health-authority interactions for assigned programs.
  • Senior Director: Leads complex global programs, influences portfolio strategy, and provides significant cross-functional and partner-company leadership.

Location and Travel

This position can be remote or based at Synthekine’s Menlo Park, CA headquarters and will follow the company’s hybrid on-site schedule. Occasional domestic and international travel is expected for health-authority meetings, partner interactions, and scientific conferences.

Reporting

This position reports to the Head of Regulatory Affairs and works in close partnership with the Clinical Development and Program Leadership teams.

Compensation and Benefits

The anticipated annual base salary range for this position is $220,000 to $290,000. Actual compensation will be determined by geographical location, work experience, education, and/or skill level. Total compensation additionally includes an equity grant, an annual performance bonus, and a comprehensive benefits program.

Equal Employment Opportunity

Synthekine is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other characteristic protected by applicable law.