Job DescriptionWe 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.
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.
Qualifications- 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.
The annual base salary for this position ranges from $188,000 to $212,000. In addition, this position is eligible for an annual performance pay bonus. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package. Additional details can be found on our careers website: www.alkermes.com/careers#working-here
