Role Overview
As Senior Manager, Clinical Science, you will play a central role in shaping and advancing clinical development initiatives. You'll ensure scientific rigor and regulatory compliance across all stages of clinical research, from study design through data interpretation and reporting. This position requires close coordination with internal teams, external partners, and regulatory bodies to deliver high-quality clinical outcomes.
Key Responsibilities
- Lead the development, revision, and review of clinical protocols, amendments, and synopses
- Prepare and evaluate informed consent forms, investigator brochures, and clinical study reports
- Support the creation of regulatory documents including INDs, NDAs, Development Safety Update Reports, and Health Authority briefings
- Contribute to Orphan Drug applications, annual reports, and benefit-risk assessments
- Collaborate with Clinical Operations on trial start-up, monitoring, and closeout activities
- Assist in budget planning and resource allocation for clinical trials
- Conduct therapeutic area research and competitive landscape analysis
- Review, interpret, and present clinical data to internal and external stakeholders
- Respond to scientific inquiries from investigators, ethics boards, and regulatory agencies
- Develop clinical presentations and program updates for cross-functional use
- Track performance metrics and ensure alignment with strategic objectives
- Maintain compliance with ethical and regulatory standards in all activities
Qualifications
- Doctoral degree (PharmD, PhD, or MD) in a clinical or scientific discipline
- Minimum of three years of experience in clinical development within pharma, biotech, or CRO settings
- Working knowledge of clinical trial phases (1–4), GCP, and ICH guidelines
- Proven ability to analyze clinical data and interpret scientific literature
- Strong problem-solving skills with attention to accuracy and detail
- Excellent organizational capacity to manage multiple priorities and meet deadlines
- Clear, effective communication style with adaptability across audiences
- Skilled at building collaborative relationships across departments and with external partners
- Demonstrated initiative and commitment to team success
Work Environment
This is a hybrid position with approximately 25% travel required, including domestic and international destinations. The role supports a culture grounded in patient focus, scientific excellence, and inclusive collaboration.
Compensation and Benefits
- Annual salary range: $141,800 – $186,800
- Eligibility for annual bonus (non-commercial roles) or incentive compensation (commercial roles)
- Discretionary equity awards and Employee Stock Purchase Plan participation
- Comprehensive medical, dental, and vision insurance
- 401(k) with company match, FSA/HSA options
- Life insurance, paid time off, and wellness programs
Our Commitment to Diversity
We are an equal opportunity employer that values diversity and inclusion. Employment decisions are based on merit, qualifications, and business needs without regard to race, religion, age, sex, gender identity, sexual orientation, disability, national origin, veteran status, or other protected characteristics.
