Director/Sr. Director, Regulatory CMC

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 our Technical Development and Manufacturing will soon be moving to a brand new facility in Bedford, MA to support our growth.  Obsidianites enjoy a highly collaborative culture, competitive salary and benefits, and potential for ownership through stock options.

Our Opportunity… 

We’re looking for a CMC regulatory lead, passionate about taking teams to the finish line for regulatory submissions supporting novel engineered cell therapy products. In this role you’ll contribute to the IND for the first autologous cell therapy product in our pipeline targeting cancer.  Your strategic guidance will be incorporated in the development of our pivotal process and product.  You will also oversee our early-stage product portfolio.  As part of our Regulatory department, you’ll be a vital part of a highly collaborative team working to achieve Obsidian’s vision by translating innovative science into medical breakthroughs for patients. 

This is a unique opportunity to be a contributor in a well-funded pre-clinical company with blue chip investors, field-leading advisors, best-in-class partners (BMS and Vertex), and an experienced team. You'll help us build a dynamic, innovative, passionate, collaborative, and successful organization focused on delivering transformative therapies in areas of greatest clinical need. 

You Will… 

Independently manage content development, compilation, and review of module 3 for regulatory submissions, including IND/Clinical trial applications and BLA applications, ensuring that these documents meet regulatory requirements.  Draft, propose text, and provide tables as needed to clarify content expectations and support the authoring team.  Manage the full lifecycle of open INDs and CTAs in compliance with regulations.  Lead CMC related interactions with Health Authorities, including RTQs, meeting package preparation, and meeting participation. Prepare and manage CMC submissions, working with publishing vendor(s), regional consulting leads for international submissions, and internal SMEs in Research, Process Development and Manufacturing.  Develop, communicate, and execute phase-appropriate global CMC regulatory strategy to support development projects and business objectives; create and maintain regulatory strategy documents.  Provide strategic regulatory input to support pivotal cell therapy process/product readiness.   Identify and communicate CMC regulatory risks and impact to timelines  Maintain responsibility for CMC regulatory timelines (eg MS Project).  Review and provide regulatory assessments for relevant quality systems such as change controls.  Conduct CMC regulatory diligence for potential partnerships and quality agreements.  Form strong, collaborative partnerships with internal CMC team and foster positive working relationships with external partners.   Utilize electronic systems (eg Sharepoint) for document authoring and regulatory submission/communication archiving.  Lead the growth and development of the CMC regulatory team to cover the project portfolio as the company expands. 

You Bring… 

Core Qualifications 

Bachelor’s degree in a scientific field.  A minimum of 10 years of work experience with global exposure in CMC regulatory in biologics.  Experience with cell therapy products.  CMC regulatory expertise through all stages of a product’s lifecycle from early stage preclinical through marketing application.   Demonstrated successful management of complex regulatory submissions.  Direct interaction with Health Authorities/FDA.  Mastery of global CMC/GMP regulations (ICH, EMA, FDA).  Ability and interest in performing both tactical and strategic work  Strong leader with exceptional written communication skills and attention to detail.  Competence delineating between regulatory requirements and recommendations appropriate for the phase of development (clinical vs. marketing application).  A collaborative working style as a tackler, not a blocker.  A leadership style orientated to high standards and support. You engage input of team members in problem solving and decision making and encourage open honest dialogue.  A desire and ability to work in an entrepreneurial, collaborative environment. You build healthy, productive and high trust relationships within your function and with direct stakeholders, and effectively influences actions and decisions.  A flexible and creative mindset; able to productively challenge and be challenged to generate the best ideas to advance project and company goals.  An ability to operate and adapt in a fast paced, rapidly developing environment. 

Bonus Qualifications 

Experience with oncology.  Global CMC regulatory filing experience with cell therapy product.  Background in quality.  Experience with clinical and/or nonclinical regulatory 

Job level will be based on overall experience and capabilities.

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.