Director/Senior Director, Clinical Pharmacology and Pharmacometrics
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 clinical development. We recently received our IND clearance from FDA to begin our first clinical trial for the treatment of patients with metastatic melanoma.
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, Manufacturing & Quality team is based in our 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.
We’re looking for a Clinical Pharmacologist with a strong background in cell therapy and gene editing to contribute to building Obsidian’s clinical and translational pharmacokinetic and pharmacodynamic (PK/PD) capabilities. In this role, you’ll work collaboratively with members of our clinical, translational, and cell therapy teams to lead the clinical and pre-clinical investigation of pharmacokinetic and pharmacodynamic (PK/PD) relationships for novel regulated cell therapies.
As part of our Translational Early Clinical Development group, 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, starting with our lead program OBX-115, engineered to make TILs more effective for more patients.
This is a unique opportunity to be a contributor in a well-funded 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.
- Integrate pharmacokinetic and pharmacology expertise to support clinical and preclinical activities for our lead and exploratory programs, including regulated, engineered tumor infiltrating lymphocytes (TILs) and gene-edited T cell therapies.
- Support pre-IND activities including FIH dose selection.
- Collaborate cross-functionally with Research/Biometric/Bioinformatics/Clinical/Translational team to analyze and integrate PKPD and activity readouts to inform dose optimization, dose-escalation/expansion and RP2D decisions.
- Lead the execution of clinical pharmacology studies.
- Author and review documents like clinical protocols, and regulatory submissions such as briefing documents, INDs, IB, clinical study reports, CTAs and NDAs.
- Manage external vendors to support pharmacometric and population-based PK/PD modeling efforts.
- Maintain current knowledge of the field and area(s) of scientific and technical expertise and development.
- A PhD degree in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Applied Mathematics, or a related discipline, and 10 +/- years of related clinical pharmacology experience.
- Strong knowledge of drug development and FDA and ICH guidance documents.
- Experience managing external service providers and CRO’s with timely delivery of clear, accurate and well-written study findings required.
- Proficiency with hands-on data analysis, modelling, and reporting using Phoenix WinNonLin, MatLAB, Rstudio, NonMem, or equivalent.
- Strong knowledge of and user competency in additional common software and data analysis packages (e.g., Microsoft Office Suite, SoftMax Pro, GraphPad Prism, JMP).
- Self-motivation and a proven ability to work with general direction to meet objectives and timelines.
- 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, invite and share feedback and ideas, and effectively influence actions and decisions.
- Flexibility, you readily adapt to changes and priorities in order to fulfill our mission.
- Strong technical writing and scientific skills.
- Solid project management skills and experience managing complex projects.
- Excellent communication skills.
- Strong knowledge and experience of cell therapy and gene editing platforms.
- Prior experience in clinical oncology and with engineered and gene edited T cell therapy platforms
- Prior experience with small molecule-based clinical pharmacology.
Work location: Hybrid (Cambridge, MA)
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.