Transcendtherapeutics
Associate Director, Clinical Operations
New York City (Hybrid) · Director
Sponsorship not specified$180k-$210kDetected 222 days ago
GCPComplianceLogisticsProcess ImprovementClinical TrialsFDA RegulatoryLeadershipCommunicationCollaborationMentoring
About the role
- The Associate Director (AD), Clinical Operations is a key member of the Clinical Operations team, with responsibility for overseeing the execution of Transcend's clinical trials.
- This position is highly visible in a small, growing organization which may provide for the opportunity for rapid advancement.
- This position will report to the Senior Director, Clinical Operations.
Responsibilities
- The AD will help drive trial operational strategy.
- The AD will manage essential duties and responsibilities as independently as possible, with guidance and oversight provided by a Senior Director, Clinical Operations when needed.
- Support the Clinical Trial Manager with planning and strategy for implementation and execution of assigned clinical trials from study startup through close-out
- Identify, prepare, and implement departmental process improvement initiatives to improve operational efficiencies
- Support creation, review, and revision of clinical SOPs
Requirements
- All other duties as required
- Bachelor's degree, preferably in a life science
- Proficient knowledge of GCP/ICH, drug development process, clinical operations
Nice to have
- Company Overview
- TSND-201 was granted Breakthrough Therapy designation by the FDA based on Phase 2 results, and we have aligned on a Phase 3 program for TSND-201 in PTSD.
- Experience executing clinical trials in a small team or at a small pharmaceutical company is preferred
- Experience conducting studies in psychiatry-related indications is preferred
Compensation
- We offer competitive cash and equity compensation; medical, dental, and vision insurance; 401k; unlimited vacation and sick time; and more.
Benefits
- Manage direct report(s) by providing leadership, vision and mentoring
- We offer competitive cash and equity compensation; medical, dental, and vision insurance; 401k; unlimited vacation and sick time; and more.
- The salary range for this role is $180,000 to $210,000, plus equity and benefits.
Company info
- Ensure that the clinical trials are conducted in a timely fashion and in compliance with SOPs, GCP, regulatory guidelines, company goals, and budget
- At least 7 years of clinical trial experience within a pharmaceutical company or CRO and at least 4 years in a managerial position
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