RemoteLeaf Logo
Log in Sign up

Associate Director, Clinical Operations - Late Phase

3 weeks ago
Anywhere
Full-time
Lead
Project 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

  • Lead the cross-functional Trial Team and track deliverables, milestones, risks, and CAPAs throughout the trial lifecycle.
  • Own trial budget management, including scope-change updates, cost reconciliation, and oversight of trial-level financial performance.
  • Manage trial-level contracts for external service providers, including review and approval of contracts, change orders, and service delivery.
  • Drive feasibility and site selection activities in alignment with trial timelines and Clinical Operations leadership.
  • Oversee selection, setup, scope of work, and specifications for all external service providers used in the trial.
  • Ensure trial execution complies with global health authority regulations, guidelines, SOPs, and organizational requirements.
  • Partner with Clinical Development, Medical Affairs, Regulatory Affairs, Commercial, Asset Strategy, and Program Leadership on EAP and Phase 4 strategy.
  • Provide clinical operations leadership to ensure Expanded Access Programs are compliant, scalable, ethically sound, and aligned with regulatory guidance.
  • Support health authority inspections and internal QA audits, maintaining inspection readiness across the Trial Team.
  • Ensure appropriate trial-specific training for Trial Team members, CROs, and related stakeholders, and oversee investigator meeting coordination when applicable.
  • Communicate accurate trial status updates to key stakeholders and escalate unresolved issues in a timely manner.
  • Document escalations and capture lessons learned and process improvements during and after trial milestone completion.

Requirements

  • Bachelor’s degree or equivalent required, preferably in Life Sciences such as Biology, Chemistry, Biochemistry, Nursing, or Pharmacy.
  • Minimum 6 years of experience leading late-phase clinical trials in the pharmaceutical industry or at a CRO.
  • At least 3 years of experience managing Phase 4 and/or Expanded Access Program trials, preferably in the psychiatric space.
  • Willingness and ability to travel up to 15–20% of the time based on business needs.
  • Clinical research operational knowledge with strong project planning, project management, communication, and presentation skills.
  • Ability to manage all aspects of clinical trial execution, including global or regional teams in a virtual environment.
  • Strong vendor management expertise is required.
  • Excellent leadership, decision-making, analytical, and financial management skills.
  • Experience mentoring and coaching others.
  • Ability to work with limited supervision and adapt other relevant experience or skills considered by the hiring manager.

Benefits

  • Starting base pay range of $168,856.00 to $192,641.00.
  • 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

Similar Roles

B

Project Manager (German fluent)

Brandtech+ 501-1000 Marketing services

Brandtech+ is hiring a remote Project Manager to lead creative and production projects from brief to delivery across digital, film, CGI, motion, and print work within a fast-paced global agency environment.

India Full-time Mid Level Project Manager
Email Marketing
47 minutes ago
Weekday

Project Manager Sales Marketing

Weekday 11-50 Construction & Engineering

Weekday’s client is hiring a remote Project Manager – Sales & Marketing to lead cross-functional initiatives that apply machine learning and analytics to improve customer acquisition, engagement, and revenue growth.

India Full-time Lead Marketing Manager Project Manager
$12k-$24k
Agile Machine Learning
2 hours, 7 minutes ago
NEORIS

Consultor de Change Management Sênior (GMO) – SAP S/4HANA

NEORIS 5K-10K Internet Software & Services

Consultor(a) de Change Management Sênior para atuar em um rollout SAP S/4HANA da EPAM/NEORIS no Brasil, com foco em gestão da mudança, adoção do sistema e estabilização pós-implantação em trabalho remoto.

Brazil Full-time Senior Project Manager Training Specialist
2 hours, 11 minutes ago
Affirm

People Knowledge Experience Manager

Affirm 1K-5K Diversified Financial Services

Affirm is hiring a role to build and scale a centralized Employee Experience Hub that standardizes People Operations knowledge, enables AI-assisted support, and improves employee service delivery across the organization.

United States Full-time Senior People Operations Project Manager
$115k-$170k
2 hours, 17 minutes ago

You're on a roll! Sign up now to keep applying.

Sign Up

Already have an account? Log in

Used by 14,729+ remote workers