Medical Director, Early Phase and PK
About The Position
Definium Therapeutics, formerly known as Mind Medicine, is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health. Founded in 2019, we are continuously expanding our presence and global footprint. We are constantly searching for high-impact individuals in various clinical, technical and business operations domains to strengthen our team of patient-centric, intelligent individuals. This role is U.S. based, fully remote The Medical Director Early Phase and PK plays a pivotal role in shaping the early phase clinical development strategy for the company’s candidate molecules. As part of a multifunctional team partnering with Clinical Operations, Clinical Pharmacology, Nonclinical, Regulatory, Biostatistics, and Pharmacovigilance to ensure high-quality data and alignment toward safe and successful product development. They serve as the medical SME on assigned FIH, Phase 1 and Phase 2 trials weighing in on clinical trial design and eligibility, data monitoring and reporting.
Requirements
- Advanced degree (M.D., D.O, D.N.P, Ph.D. etc.) required
- 3-5 years of clinical development experience within contract research, pharmaceutical, or academic settings, with a focus on early-stage development or translational research
- Ability to author and critically review clinical protocols, study reports, and regulatory documents, ensuring scientific integrity and compliance with ICH-GCP and global regulatory standards
- Strong communication and collaboration skills, with the ability to influence and partner effectively across cross-functional teams, investigators, and external experts
- Highly organized with the ability to manage multiple priorities in a fast-paced, evolving environment
Nice To Haves
- Experience designing and running clinical pharmacology studies (preferred), or studies with PK and PD endpoints in healthy volunteers and/or patient populations
Responsibilities
- Bring medical and scientific expertise to the design, execution, and interpretation of FIH, Phase 1, and Phase 2 clinical studies ensuring patient safety and scientific integrity
- Author and oversee key clinical documents — including protocols, amendments, informed consent forms, investigator brochures, clinical study reports, and regulatory submissions (e.g., INDs, CTAs, DSURs). Respond to health authority and IRB inquiries for respective studies
- Review, analyze, and interpret emerging clinical data (safety, efficacy, PK/PD) to identify trends and issues, ensuring timely resolution through cross-functional collaboration
- Provide ongoing data review to ensure study conduct aligns with protocol, patient safety standards, and data integrity expectations. Collaborate with Pharmacovigilance to ensure awareness of key safety and efficacy findings, supporting SAE review, narrative development, and safety governance activities
- Contribute to and present scientific and clinical data internally and externally (e.g., investigator meetings, scientific conferences, manuscripts, regulatory interactions)
- Contribute to vendor oversight to ensure consistency, quality, and scientific rigor across all clinical deliverables. Interact with investigators as needed, assist in site selection, and support training of sites at study start-up
Benefits
- 100% paid health benefits including Medical, Dental and Vision for you and your dependents
- 401(k) program with company match and vesting after the turn of the first month after your start date
- Flexible time off
- Generous parental leave and some fun fringe perks!
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
