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Senior Director, Clinical Development

4 months, 3 weeks ago
Anywhere
Full-time
Lead
Program Manager
Project and Program Management
Apply Now
Definium Therapeutics

Definium Therapeutics

Definium Therapeutics is dedicated to advancing psychiatry by developing accessible treatments that leverage the therapeutic potential of psychedelic medicine, guided by scientific rigor and a commitment to addressing the root causes of mental health i...

Health Care Providers & Services
51-250
Founded 2019
View All Jobs 5

Description

  • Provide clinical science leadership within assigned teams or programs.
  • Manage the design, planning, and execution of clinical trial programs with minimal guidance.
  • Serve as a clinical science representative on US and global clinical studies to support registration-quality data.
  • Lead study design, implementation, and execution of clinical trials for assigned programs.
  • Prepare clinical study synopses and contribute to protocols, major amendments, data collection systems, and final clinical study reports.
  • Partner with Regulatory Affairs and Project Management to oversee the quality, coordination, and timeliness of clinical sections of INDs, Investigator Brochures, CTAs, ISSs, ISEs, and clinical expert reports.
  • Provide or supervise medical monitoring for human clinical trials, including adverse event reporting and safety management.
  • Conduct ongoing benefit/risk assessments and help investigate protocol deviations.
  • Build and maintain relationships with investigators, thought leaders, and external experts to optimize study design and execution.
  • Collaborate with Clinical Operations, Clinical Pharmacology, Regulatory, Early Development, Medical Affairs, Commercial, and other stakeholders to deliver clinical programs for registration and launch.

Requirements

  • Doctoral degree required: PhD, MD, PharmD, or PsyD.
  • 6+ years of relevant clinical development experience.
  • Strongly preferred experience in CNS development, especially psychiatry or neurology.
  • Experience in small molecule development.
  • Experience in data review and analysis, presentations, and regulatory writing, including IND and CTD sections.
  • Experience building strong relationships within cross-functional groups to achieve results.
  • Proven ability to identify and solve clinical development problems.
  • Strong understanding of the clinical development process and the broader pharmaceutical industry, including competitive and commercial considerations.
  • Experience in clinical research for psychiatry, addiction psychiatry, or addiction medicine programs is strongly preferred.
  • Background in clinical trial strategy and trial management, with IND experience strongly preferred.
  • Excellent interpersonal, verbal, and written communication skills.
  • Proven ability to work remotely with distributed internal and external interdisciplinary teams.
  • Ability to travel as required, including international travel, averaging 10-20% and reaching 50% or more in some months.

Benefits

  • Starting base salary of $247,649.00 to $298,800.00.
  • Eligibility for additional compensation, including bonus and equity.
  • 100% paid medical, dental, and vision coverage for employees and dependents.
  • 401(k) program with company match and vesting after the first month of employment.
  • Flexible time off.
  • Generous parental leave.
  • Additional fringe perks.

Interested in this position?

Apply directly on the company website

Apply Now

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