Senior Director/VP Physician-Scientist

Senior Director/VP Physician-Scientist

Cambridge, MA

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 is in a 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 motivated and patient-centric VP/Sr. Medical Director who wants to have a broad and tangible impact. Reporting to the Chief Development Officer, this role will be charged with developing and leading novel internal and externally partnered programs in the Cell and Gene Therapy space, providing medical leadership for our engineered TIL programs, influencing the development of our portfolio in oncology, and helping to define the broader clinical development strategy. You’ll be a vital part of a highly collaborative team working to achieve Obsidian’s vision starting with our lead program OBX-115 engineered to make TILs (Tumor Infiltrating Lymphocytes) more effective for more patients.

The ideal candidate will have deep expertise in early to late-stage clinical development in oncology and/or approval with strong scientific rigor and a thorough understanding of target and disease biology. This role is both strategic and hands-on. We’re seeking an individual who is collaborative, thrives in a dynamic culture, and is steadfast in their commitment to advance cutting-edge cellular therapies to impact patients’ lives.   Work location can be hybrid or remote.

This is a unique opportunity to be a key contributor in a well-funded clinical company with blue chip investors, field-leading advisors, best-in-class partners, 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…

• Provide scientific/clinical and product development leadership and support for development programs.
• Design and oversee execution of multi-layered clinical development strategies, in compliance with regulatory guidelines.
• Lead authoring of clinical sections of key documents, including Investigator’s Brochures, IND summary documents, CTAs for initiation of US and ex-US studies, and responses to questions from regulatory authorities, IRBs, and ethics committees. 
• Design and develop smaller, yet robust and innovative Phase 2 or 3 programs.
• Inform registration strategy by providing expert medical review, assessment, and interpretation of clinical data and preparing results for presentation to regulatory authorities.
• Lead collaboration with drug discovery, translational, and clinical operations teams, Phase 1 investigators and disease-specific experts to design and oversee execution of early clinical development plans.
• Interact effectively with sites, CROs, investigators, advisors, and regulatory agencies.
• Provide medical, disease-specific, and development perspective into specific research programs or broader research initiatives.
• Rapidly integrate new insights derived from ongoing clinical trials, translational science, or basic science
• Create compelling data presentations for external disclosures.
• Proactively manage communication and build strong collaborative relationships with key stakeholders both internally and externally, including interactions with academic experts, clinical trial investigators, and other clinical stakeholders.

You Bring…

Qualifications

• MD or MD/PhD. 5+ years of industry experience (we will also consider other highly qualified applicants).
• Deep knowledge and understanding of oncology cell therapy drug development paradigms.
• Experience designing and executing cell therapy trials, including development of the clinical protocol and clinical development plan.
• Demonstrated knowledge of compliance and global regulatory requirements (ICH) for development of pharmaceutical candidates / products.
• Excellent scientific standing among peers and a track record of addressing scientifically difficult issues with creative solutions.
• Excellent working relationships with key thought leaders, and investigators.
• A highly collaborative working style. You build trusting relationships, invite and share ideas and feedback, productively challenge your own and others’ assumptions to generate new ideas and facilitate better outcomes. 
• A proven ability to successfully lead cross-functional teams in a matrixed environment.
• Strategic leadership and an ability to translate strategy into tactics and successful execution.
• Personal drive, initiative, good judgment, and an ability to adapt as the organization grows and evolves.
• Outstanding written and oral communication skills; you communicate complex information clearly and succinctly.

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.