Senior Manager, Clinical Scientist
Remegen Biosciences, Inc.
- San Francisco, CA
- Permanent
- Full-time
- Contributes to the design and execution of clinical studies, including protocol development, CRF design, ICF development, data review, and study planning and implementation.
- Serve as a clinical science expert in cross-functional teams, providing scientific expertise to project teams and stakeholders.
- Collaborate with regulatory affairs to support regulatory submissions and interactions with health authorities as needed.
- Ensure the scientific integrity of clinical data and its compliance with study protocols, regulatory requirements, and ethical standards.
- Contributes to the development and execution of the company’s clinical research strategy, aligning with the overall business objectives.
- Engage with key opinion leaders, investigators, and external partners to build and maintain strong professional relationships.
- Lead and contribute to the preparation of clinical study reports, manuscripts, and presentations for scientific conferences.
- Other duties as assigned.
Education:
- Advanced degree (e.g., Ph.D., PharmD, MD) in a life sciences or related field.
- 8+ years of experience in clinical research within the biotech or pharmaceutical industry.
- Demonstrated expertise in the design, execution, and management of clinical trials.
- Experience in protocol development, CRF design, and data review.
- Strong understanding of regulatory requirements and guidelines governing clinical research (e.g., FDA, EMA, ICH).
- Excellent written and verbal communication skills.
- Ability to work cross-functionally in a fast-paced, collaborative environment.
- Strong attention to detail and problem-solving skills.
Supervisory Responsibilities: None.Equipment To Be Used: Laptop computer, other office equipment, and/or lab equipment.Typical Physical Demands: Manual dexterity sufficient to operate standard office equipment.Working Conditions: Works remotely. Occasionally called upon to work hours in excess of your normal daily schedule. Up to 10% travel.BENEFITS
Benefits:
- 401(k) and matching program
- Medical, Vision, and Dental Insurance
- Flexible Spending Account
- Short- and long-term disability
- Life insurance
- Employee Assistance Program
- Employee discounts
- Paid time off/vacation/sick time
- Professional development assistance
- Referral program