Senior Manager, Clinical Scientist

ORGANIZATION

RemeGen Biosciences is a biopharmaceutical company, focusing on the discovery and development of innovative medicines for the treatment of cancer and autoimmune diseases, based in South San Francisco, California, and Rockville, Maryland. By leveraging our deep insights into oncology and immunology, advanced protein engineering/design technologies, and extensive knowledge in clinical development, our vision is to uncover the novel therapeutic targets and develop the best-in-class and first-in-class biotherapeutics for the patients with significant unmet medical needs. RemeGen Biosciences is a wholly owned subsidiary of RemeGen Co. Ltd, a global pharmaceutical company specialized in autoimmune, oncology and ophthalmic diseases.

Position Summary

The Senior Manager, Clinical Scientist will be responsible for leading clinical science aspects in the planning, execution, and management of our clinical trials. The position will have a strong background in clinical research, with a proven track record of success in leading studies from concept, execution, data review, regulatory submissions, to publication. This role will be instrumental in shaping our clinical strategy, driving our research forward, and ensuring the highest standards of scientific integrity and compliance. This is a remote position for candidates located in Massachusetts, Pennsylvania, South Carolina, and Texas.

Key Responsibilities

• 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
  
  

Requirements

Education:

• Advanced degree (e.g., Ph.D., PharmD, MD) in a life sciences or related field
  
  

Experience:

• 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
  
  

Skills:

• 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
  
  

Other

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
  
  

RemeGen Biosciences is an Equal Opportunity Employer. RemeGen Biosciences’ success depends heavily on the effective utilization of qualified people, regardless of their race, ancestry, religion, color, sex, age, national origin, sexual orientation, gender identity and/or expression, disability, veteran’s status, or any other characteristic protected by the law. As a company, we adhere to and promote equal employment opportunity (EEO) for all.

Must be able to work legally in the United States without sponsorship from employer.

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