Job Description
About the company
An innovative biotech organization dedicated to transforming the treatment landscape for neuropsychiatric disorders. Their mission is to develop next-generation therapies that address significant unmet needs in mental health. With a robust pipeline and a lead program advancing into late-stage clinical development, we are poised to make a meaningful impact on patients’ lives.
Role Overview
We are seeking an accomplished Clinical Scientist to join our Clinical Development team. This role will play a pivotal part in shaping and executing late-phase clinical trials (Phase 2–3) for programs targeting major depressive disorder (MDD) and other neuropsychiatric conditions. The ideal candidate brings deep scientific expertise, thrives in a dynamic environment, and has a proven track record of supporting complex clinical programs in neuroscience.
Key Responsibilities
- Provide scientific leadership for Phase 2–3 clinical trials, ensuring alignment with study objectives and therapeutic strategy.
- Partner with cross-functional teams—including Clinical Operations, Biostatistics, Data Management, and Medical Monitoring—to drive trial execution and data integrity.
- Conduct regular site engagement visits to foster strong investigator relationships and ensure scientific rigor at the site level.
- Review and interpret clinical data to maintain consistency, quality, and adherence to protocol; contribute to blinded data reviews and interim analyses.
- Support the development of core clinical documents, including study protocols, synopses, clinical study reports, and regulatory submissions (IND, NDA).
- Collaborate with external experts and Key Opinion Leaders (KOLs) to inform study design and enhance scientific credibility.
- Participate in safety monitoring activities, including adverse event review and safety review meetings.
- Contribute to scientific publications, abstracts, and presentations based on clinical trial outcomes.
- Mentor and manage Clinical Scientist team members as the function scales.
Qualifications
- Advanced degree (PhD, MD, PharmD, or equivalent) in a scientific or clinical discipline; specialization in neuroscience or psychiatry strongly preferred.
- Minimum of 6 years’ experience in clinical development within the biotech or pharmaceutical industry, with a focus on psychiatry or CNS disorders.
- Demonstrated experience in late-phase clinical trials (Phase 2–3) for neuropsychiatric indications, ideally including MDD.
- Strong knowledge of GCP, regulatory requirements, and clinical trial methodology.
- Excellent communication and interpersonal skills, with the ability to work cross-functionally in a fast-paced environment.
- Willingness to travel up to 20% for site visits and scientific meetings.
Preferred Experience
- Direct interaction with KOLs and advisory boards in psychiatry or CNS.
- Familiarity with depression rating scales (e.g., MADRS, HAM-D, PHQ-9).
- Exposure to digital health tools, ePRO, or decentralized trial models.