Job Details
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 Director Clinical Scientist is a pivotal role responsible for guiding the clinical science aspects of protocol development, study planning, data generation, and reporting for assigned projects. This position demands a high level of collaboration with cross-functional teams, including medical, regulatory, clinical operations, and biostatistics, to ensure the effective design and execution of clinical studies. This is a remote role open to candidates in Massachusetts, Pennsylvania, South Carolina, and Texas.
KEY RESPONSIBILITIES
- Lead the clinical science component of protocol development and study design.
- Oversee patient eligibility reviews and post-randomization data assessments.
- Summarize and interpret clinical study data, ensuring accurate technical reporting aligned with clinical outcomes.
- Work closely with cross-functional teams to drive patient recruitment and retention strategies.
- Participate in ongoing trial data reviews with medical teams and advisors to maintain data quality and integrity.
- Collaborate in preparing regulatory submission briefing books and other clinical documentation.
- Assist in drafting and reviewing scientific publications, informed consents, and clinical study reports.
- Ensure adherence to SOPs and company policies in clinical trial conduct.
- Handle additional tasks as required to support project needs.
REQUIREMENTS
Education:- Doctoral Degree including PharmD, PhD in Sciences, or MD degree, is required.
- BA degree in Health Care or related field, with demonstrated experience in the field of at least 15 years.
Experience:- Minimum 10 years related scientific and technical experience in clinical research.
- Comprehensive knowledge, understanding and application of principles, concepts and practices of clinical research is required.
Skills:- Ability to interpret and communicate technical and scientific data to clinical and non-clinical audiences.
- 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. May require approximately 10% travel, both domestic and international.
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.