Director/Sr. Director/Executive Director, Clinical Regulatory Affairs

About the Company

SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications, alongside a robust preclinical pipeline of potential cancer therapeutics in the discovery and IND-enabling stages.

About the Role

The Regulatory Affairs (Clinical/Nonclinical) role will drive regulatory strategy and execution within SystImmune’s project development teams and the Regulatory Affairs Department in all aspects of global regulatory affairs related to the development of novel oncology therapeutics (e.g., ADCs, bispecific antibodies, and T-cell engagers). The primary focus is on global regulatory aspects of preclinical and clinical oncology drug development, ensuring compliance with global health authority regulations. The level for this role could range from Director to Executive Director based on expertise, prior oncology regulatory experience, and global regulatory agency experience, including successful BLA/MAA filings and label negotiations.

Prior experience working across partner companies in a collaborative setting is highly desired. Leadership, attention to detail, and the ability to drive data-informed decision-making in a fast-paced environment are strongly desired, along with the flexibility to toggle between "player" and "coach" roles as needed.

Responsibilities

• Integrate scientific, medical, and regulatory perspectives to drive development of innovative global regulatory strategies to achieve rapid approvals for investigational and marketing plans from agencies such as FDA, EMA, PMDA, and NMPA (China).
• Perform research to drive development of regulatory strategy for assigned clinical development programs.
• Lead and drive preparation for Agency meetings and associated briefing document preparation.
• Lead and manage queries and commitments with regulatory agencies; collaborate with subject matter experts to provide written responses to queries and provide periodic status updates regarding conditions/commitments.
• Represent regulatory affairs for study-level activities and participate in cross-functional departmental team projects and product development meetings.
• Own and drive the preparation, submission, management, and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development, including BLA/INDs/CTAs, amendments, information requests, Orphan drug applications, Annual Reports, and Investigator’s Brochures.
• Maintain up-to-date knowledge of regulatory requirements, comment on draft regulatory guidance, and communicate changes in regulatory information as needed.
• Exercise discretion, demonstrate integrity, and use independent judgment in performing duties.

Qualifications

• Advanced degree (e.g., Ph.D.) with excellent scientific/analytical thinking abilities and strong written and verbal communication skills.
• A minimum of 5 years of prior pharmaceutical industry experience, preferably in novel biologic/ADC-based oncology drug development, with at least 3 years of global regulatory strategy experience.
• A solution-centric mindset with a drive to learn and grow, and the ability to thrive in a fast-paced small company environment.
• Prior experience working in cross-company joint development collaboration settings is highly desired.

Preferred Attributes

• Deep and comprehensive understanding of US FDA, ICH, and international pharmaceutical guidance, regulations, drug development processes, and industry standard practices.
• Prior experience working with collaborating sponsors across companies and geographic regions, including China, in novel oncology product development.
• High attention to detail; ability to coordinate and prioritize assigned projects according to corporate goals.
• Strong basic science, clinical, and medical foundation with excellent interpersonal skills, both written and verbal.

Pay

The expected base salary range for this role is $200,000 to $300,000 annually, with final base salary determined by the level at which a candidate is hired. Actual compensation will reflect qualifications, experience, and skill set. Offers may extend toward the higher end of the range for exceptional candidates whose background and expertise exceed the role’s requirements.

Benefits

• 100% paid employee premiums for medical, dental, and vision coverage.
• Short-term disability (STD) and long-term disability (LTD) insurance.
• 401(k) plan with a 50% company match of up to 3% and a vesting schedule of 5 years.
• 15 PTO days per year, sick leave, plus 11 paid holidays.