Note: The job is a remote job and is open to candidates in USA. Transcend Therapeutics is a late-clinical-stage neuroscience company developing rapid-acting treatments for neuropsychiatric diseases. The Director, Clinical Development will provide medical oversight of clinical trials and advance the clinical development of assigned compounds, working closely with the clinical operations team and study sites.
Responsibilities
- Lead the development and execution of clinical trial protocols for assigned programs, ensuring scientific rigor and regulatory compliance
- Provide medical oversight for assigned clinical trials, including acting as the medical monitor
- Proactively review clinical trial data to ensure patient safety and data quality
- Analyze, interpret, and communicate clinical trial data to inform key decisions, providing clear recommendations to guide clinical development strategy
- Contribute to authoring of key clinical documents: protocols, investigator’s brochure, clinical study reports, regulatory submissions, and publications
- Establish and maintain strategic relationships with key opinion leaders (KOLs), clinical investigators, and external stakeholders to advance clinical initiatives
- Support creation, review, and revision of clinical development SOPs
- In collaboration with the clinical operations team, ensure that the clinical trials are conducted in a timely fashion and in compliance with SOPs, GCP, regulatory guidelines, company goals, and budget
- All other duties as required
Skills
- MD or equivalent with 5+ years drug development experience in a pharmaceutical company, with 2+ years' experience in neuroscience-related indications. Candidates with relevant experience in academia, or a related environment may be considered
- Knowledge of FDA and global regulatory requirements and guidelines (e.g., MHRA, EMA) and clinical development processes
- Proficient knowledge of GCP/ICH, drug development process
- Experience working in a small team, fast-paced team
- Strong analytical and problem-solving skills, with a data driven approach to decision making
- Excellent verbal, written, communication and interpersonal skills
- Detail-oriented, with a desire to ‘get in the weeds' and understand the nuances
- Flexible, able to pivot when needed in a fast-paced environment
- Able to align with company goals and focus on the big picture
- Internally motivated, with a passion for mental health
- Routinely takes initiative
- Board-certified psychiatrist preferred
- Preferred experience participating in meetings with regulatory authorities, including preparing meeting materials and meeting preparation
Benefits
- Equity compensation
- Medical, dental, and vision insurance
- 401k
- Unlimited vacation and sick time
Company Overview