Senior Principal Scientist, Precision Medicine Neuroscience
About The Position
Oversees the direction, planning, execution, and interpretation of the precision medicine strategy for clinical trials or research activities within a clinical program. Leads and participates in cross-functional teams to generate, deliver, and interpret high-quality clinical biomarker data that supports the product’s scientific and business strategy. Manages precision medicine strategy and its implementation in support of the Product Development Plan, drawing on medical and scientific principles, regulatory and compliance requirements, and knowledge of customers, markets, business operations, and emerging issues. The role also contributes scientific content to clinical and regulatory documents, supports opinion-leader interactions, and ensures research adheres to applicable quality and regulatory standards.
Requirements
- PhD in science or a related field and 10 years of related work experience, or equivalent education and work experience.
- Ability to lead and develop a precision medicine strategy.
- Strong desire to collaborate in a cross-functional setting.
- Clinical trial experience in the pharmaceutical industry or academia.
- Knowledge of clinical trial methodology and regulatory and compliance requirements governing clinical trials.
- Experience designing study protocols.
- Ability to interact externally and internally to support global scientific and business strategy.
- Excellent oral and written English communication skills.
Nice To Haves
- Strong background in migraine/pain and/or obesity.
Responsibilities
- Manage the design and implementation of the precision medicine strategy in support of the overall Product Development Plan.
- Lead cross-functional precision medicine teams to develop a strategy that may extend biomarker planning from discovery to the clinic.
- Develop a rigorous, cross-functionally aligned, and vetted precision medicine strategy in collaboration with matrix team members.
- Oversee the precision medicine strategy, including timelines, budgets, interpretation, and communication of accumulating biomarker data to key stakeholders.
- Contribute to the design, analysis, interpretation, and reporting of scientific content for protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents.
- Participate in opinion-leader interactions related to the disease area, partnering with Medical Affairs, Commercial, Clinical Development, and other functions as required and consistent with corporate policies.
- Stay current with professional information and technology through conferences, medical literature, and other available training.
- Understand and comply with regulatory requirements related to clinical studies and global drug development; contribute to regulatory responses and discussions as requested.
- Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures, and other quality standards in research.
Benefits
- Paid time off, including vacation, holidays, and sick time.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) for eligible employees.
- Eligibility to participate in long-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
