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Associate Director, Clinical Development – MDD
Definium Therapeutics. Serve as a responsible member and clinical science representative on global development teams .
About the role
Key responsibilities & impact- 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
Requirements
What you’ll need- Doctoral degree required (PhD, MD, PharmD, PsyD, MA, LCSW)
- Minimum of 3 years of clinical development experience
- Experience in CNS development (psychiatry or neurology) strongly preferred
- 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.
Benefits
Comp & perks- 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!
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical developmentregulatory writingdata reviewstatistical analysisclinical trial data evaluationclinical protocol writingclinical study report writingmanuscript writingdata science approachesCNS development
Soft Skills
collaborationcommunicationinnovationcontinuous improvementleadershipcross-functional teamworkorganizational skillsattention to detailproblem-solvingadaptability
Certifications
PhDMDPharmDPsyDMALCSW