Associate Director, Clinical Development

Definium Therapeutics; Durham (NC); On-site; USD 169,814 - 192,241; Full time

Benefits offered by this job

100% paid health benefits

401(k) program with company match

Flexible time off

Generous parental leave

Fringe perks

Job summary

Definium Therapeutics is seeking an Associate Director, Clinical Development to lead clinical studies, offering expertise in CNS development. This role involves collaborating with cross‑functional teams, writing protocols, and ensuring quality in regulatory submissions. The position offers a starting base pay of $169,814.00 - $192,241.00, with additional compensation and benefits including 100% paid health benefits, a 401(k) match, and flexible time off. A doctoral degree and a minimum of 3 years in clinical development are required.

Qualifications

• Minimum of 3 years of clinical development experience.
• Experience in CNS development (psychiatry or neurology) preferred.
• Strong understanding of late-stage clinical development and regulatory processes.

Responsibilities

• Serve as clinical science representative on global development teams.
• Collaborate with partners to provide clinical development expertise.
• Write and edit clinical protocols and study reports.

Skills

Clinical development experience

CNS development expertise

Regulatory writing

Collaborative skills

Written and verbal communication

Education

Doctoral degree (PhD, MD, PharmD, PsyD, MA, LCSW)

Job description

The Associate Director, Clinical Development plays a key role in the design and execution of ongoing and new clinical development studies. This position serves as the clinical science representative on one or more U.S. and/or global clinical studies and contributes to the delivery of high‑quality clinical data to support registration and launch. The role partners cross‑functionally with Clinical Operations, Clinical Pharmacology, Regulatory Affairs, Early Development, Medical Affairs, Commercial, and external vendors.

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

Qualifications

• 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

Other Skills & Requirements

• 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)

Compensation

The starting base pay range for this position is $169,814.00 - $192,241.00. Compensation will be determined based on several factors including, but not limited to, skill set, years of experience, and the employee's geographic location. Employees may be entitled to additional compensation, including bonus and equity. Benefits information is listed on our Jobs Page.

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!