About Us…

Obsidian Therapeutics is pioneering engineered cell and gene therapies to deliver transformative outcomes for patients. Obsidian’s programs apply our CytoDriveTM technology in Cell and Gene therapy products to control expression of proteins for enhanced therapeutic efficacy and safety. Obsidian’s lead program is currently in preclinical development for the treatment of patients with metastatic melanoma and other solid tumors.

We’re proud of our diverse talented team and committed to cultivating an environment of inclusion where each person feels a strong sense of belonging and is supported to continuously learn and contribute their best work. Our Research team is based in the heart of Cambridge, MA, and Technical Operations team is based in our brand-new facility in Bedford, MA. Obsidianites enjoy a highly collaborative culture, competitive salary and benefits, and potential for ownership through stock options.

Our Opportunity…

We are looking for a motivated and pragmatic Director, Clinical Regulatory, to join our team. This individual will lead clinical regulatory strategy for OBX-115, owning the clinical components of our global regulatory plan and serving as the key executor for clinical regulatory submissions and projects. The ideal candidate combines strategic vision with hands-on execution, ensuring compliance and timely delivery across global regulatory activities.

You Will…

Plan, prepares, and review clinical submissions to regulatory authorities.
Oversee preparation and submission of End-of-Phase (EOP) meeting materials.
Own all compliance submissions, including:
SUSARs (Suspected Unexpected Serious Adverse Reactions)
Investigator updates
Annual reports / DSURs
Manage Draft Label development for OBX-115 and ensure compliance with regulatory standards.
Complete and submit Pediatric Study Plan in accordance with regulatory requirements.
Lead regulatory activities for Australia and Canada submissions related to pivotal clinical studies.
Ensure timely and accurate generic and proprietary name submissions as required.
Provide oversight for protocol amendments and ensure regulatory compliance throughout clinical trial lifecycle.
Evaluate and recommend improvements to the Regulatory Management System for efficiency and compliance.
Lead development and maintenance of the Global Regulatory Plan, ensuring alignment with CMC regulatory strategy and overall forward-looking objectives.
Develop comprehensive Pre-BLA and BLA submission plans to support product approval timelines.
Collaborate with internal stakeholders (CMC Regulatory, Clinical Development, Clinical Operations, Tech Ops, Regulatory Affairs leadership) to ensure integrated regulatory strategies.
Act as a key advisor on regulatory implications for clinical development decisions.
Represent clinical-regulatory on cross functional teams
Author regulatory documents in a hands-on manner; manage review, roundtables and incorporation of feedback.
Own regulatory project timelines in partnership with project management
Contribute to regulatory agency meeting timing and strategy in conjunction with head of regulatory with CMC regulatory input.
Interact with regulatory agencies as needed

You Bring…

Core Qualifications

BA/BS in relevant scientific discipline with 12+ years of experience. (Advanced degree is a plus)
A minimum of 8+ years directly supporting/overseeing Clinical Regulatory.
Experience with Cell or gene therapy in oncology
Experience authoring regulatory documents, managing regulatory timelines and projects
Demonstrated leadership in FDA meetings, ideally EOP/pivotal negotiation
Thorough knowledge of US and international regulations in major regions, including: US, AUS, CAN, EU
Strong familiarity with cell and gene therapy guidance, along with ability to survey new precedent, ICH/FDA guidance documents, and competitor landscape to provide regulatory assessments for questions from cross-functional team
Attention to detail, strong analytical skills, and effective problem-solving abilities, while also demonstrating adaptability to thrive in a fast-paced, high-growth environment

Obsidian is committed to equitable and transparent pay practices.

The anticipated base salary range for this role is below. The actual base salary offered will be determined based on a combination of factors, including applicable qualifications, level of education, the depth of experience, unique skills, geographic location, internal equity, and/or business needs. The actual base salary offered will be in accordance with federal, state, and/or local wage requirements for the role’s location.

Our competitive compensation package includes an annual incentive bonus as a percentage of actual base salary and long-term incentives in the form of employee stock options, both of which are commensurate with the role’s level. We also offer a generous benefits package which includes comprehensive medical, dental, and vision coverage; company contributions to health savings and retirement accounts; ample paid time off; access to wellness programs; and rich career growth opportunities.

Anticipated Base Salary Range

$211,500—$258,500 USD

Obsidian is proud to be an equal opportunity employer, cultivating a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.

Director, Clinical Regulatory

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