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Associate Director, Clinical Development

2 weeks, 6 days ago
Anywhere
Full-time
Senior
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 19

Description

  • Serve as the clinical science representative on one or more US and/or global clinical studies.
  • Partner with Clinical Operations, Clinical Pharmacology, Regulatory, Early Development, Medical Affairs, Commercial, and other stakeholders to deliver clinical programs.
  • Provide clinical development expertise and leadership as a member of the clinical and/or global development team.
  • Evaluate and present therapy area medical and scientific data and trial results.
  • Write and edit clinical study protocols, clinical study reports, manuscripts, and other study-related documents.
  • Oversee the quality, coordination, and timeliness of clinical sections of INDs, Investigator Brochures, CTAs, ISSs, ISEs, and clinical expert reports.
  • Monitor patient data and study-related information from source documents, research records, and site visits.
  • Liaise with statisticians and programmers to develop and implement statistical analysis plans.
  • Work with Medical Writing to prepare abstracts, manuscripts, and presentations for external meetings.
  • Act as the clinical science lead to CROs and other vendors.

Requirements

  • Doctoral degree required: PhD, MD, PharmD, or PsyD.
  • 3+ years of clinical development experience.
  • Strongly preferred experience in CNS development, especially psychiatry or neurology.
  • Strong knowledge of the late-stage clinical development process.
  • Solid understanding of the pharmaceutical industry, competition, and commercial operations.
  • Experience in small molecule development and ideally registration.
  • Experience with data review and analysis, internal and external presentations, and regulatory writing, including IND and CTD sections.
  • Experience building strong relationships across Clinical Operations, Regulatory, Product Development, Medical Affairs, and Commercial teams.
  • Excellent writing and communication skills.
  • Managerial skills are a plus.
  • Ability to anticipate challenges, handle obstacles, and develop contingencies.
  • Willingness and ability to travel as required, including international travel, averaging 10-20% and up to 50% or more in some months.

Benefits

  • Starting base pay range of $169,814 to $192,241.
  • Additional compensation may include 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.
  • 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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