About The Position
We are currently seeking an Associate Director, Clinical Research Scientist (CRS) to join our Clinical Development Group. This position will report to the Senior Medical Director and play a role in the design, execution, and oversight of clinical trials in the CNS space.
Requirements
- Advanced degree (Ph.D. or Pharm.D.) in a neuroscience or a related field.
- Minimum of 6-8 years of experience in clinical research within the pharmaceutical or biotechnology industry, with demonstrated experience in clinical trial design and execution.
- Strong expertise in neurology and CNS disorders.
- Proven track record of leading clinical research initiatives and contributing to strategic development plans.
- Experience interacting with clinical investigators, and key medical experts.
- Strong knowledge of ICH, GCP and other relevant regulatory guidelines.
- Exceptional communication and collaboration skills to work effectively in a matrixed environment.
Responsibilities
- Lead clinical data review activities for assigned studies or programs, ensuring data quality and timely identification of key findings.
- Support DSMB activities, including preparation of materials and interpretation of outputs.
- Contribute to the development of clinical study protocols, ensuring alignment with program objectives and regulatory requirements.
- Partner with cross-functional teams to define study endpoints, inclusion/exclusion criteria, and research methodologies.
- Oversee the selection and validation of clinical outcome measures and data collection methods.
- Conduct comprehensive literature reviews to support clinical trial design and development plans.
- Summarize and present clinical data and insights to cross-functional teams; contribute to leadership presentations as needed.
- Contribute to the creation and execution of clinical development plans spanning early to late-phase development (Phase 1-3).
- Research opportunities for new indications for a given molecule.
- Provide scientific input into regulatory documents and support health authority interactions, including FDA communications.
- Monitor the competitive landscape and emerging science in CNS/neurology, sharing relevant insights with the team.
- Contribute to scientific publications, including abstracts, manuscripts, and presentations at medical conferences.
- Establish and maintain relationships with key opinion leaders (KOLs), clinical investigators, and external experts.
Benefits
- Annual performance pay bonus
- Competitive benefits package
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Education Level
Ph.D. or professional degree
