Note: The job is a remote job and is open to candidates in USA. Definium Therapeutics is a late-stage clinical biopharmaceutical company focused on developing accessible treatments using psychedelics for psychiatric disorders. The Associate Director, Clinical Development plays a key role in designing and executing clinical studies, ensuring high-quality clinical data to support product registration and launch while collaborating with various cross-functional teams.
Responsibilities
- Serve as a responsible member and clinical science representative on global development teams
- Collaborate with cross‑functional partners to provide clinical development expertise in support of study execution
- Provide therapy‑area medical and scientific expertise in the evaluation and presentation of clinical trial data
- Write and edit clinical protocols, clinical study reports, manuscripts, and other study‑related documents
- Support the quality, coordination, and timeliness of clinical sections of regulatory deliverables (e.g., INDs, Investigator Brochures, CTAs, ISS/ISE, clinical expert reports) in partnership with Regulatory Affairs and Project Management
- Review and monitor patient‑level and study‑level data, including participation in blinded data review and use of data science approaches as applicable
- Collaborate with statisticians and programmers on statistical analysis plans and interpretation of clinical data
- Work with Medical Writing to support abstracts, manuscripts, and presentations for external scientific meetings
- Act as the clinical science lead to CROs and external vendors, with appropriate oversight from senior leadership
- Contribute to a culture of innovation, collaboration, and continuous improvement
- Perform additional responsibilities as assigned by leadership
Skills
- Doctoral degree required (PhD, MD, PharmD, PsyD, MA, LCSW)
- Minimum of 3 years of clinical development experience
- Strong understanding of late‑stage clinical development and regulatory processes
- Experience in data review, analysis, and regulatory writing (e.g., IND and CTD sections)
- Demonstrated ability to work collaboratively across functions
- Excellent written and verbal communication skills
- Experience in CNS development (psychiatry or neurology) strongly preferred
- Managerial experience a plus
- Proven ability to anticipate challenges and propose thoughtful, evidence‑based solutions
- Willingness to travel as required, including international travel (typically 10–20%, may reach higher during peak periods)
Benefits
- Employees in this role may be entitled to additional compensation, including bonus and equity.
- 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!
Company Overview