Remegen Biosciences, Inc.
Location
South San Francisco, CA | United States
Job description
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 pharmaceutic company specialized in autoimmune, oncology and ophthalmic diseases.
POSITION SUMMARY As the Medical Director, you will be an integral part of the leadership team, bringing medical and scientific expertise to guide our clinical development strategies. You will play a pivotal role in advancing our mission to deliver cutting-edge treatments by leading the execution of phase 2 and 3 clinical trials and ensuring their scientific and ethical integrity. This is a remote role open to candidates in Massachusetts, Pennsylvania, South Carolina, and Texas.
KEY RESPONSIBILITIES - Clinical Development Leadership: Provide medical and scientific leadership in developing clinical strategies and protocols. Ensure that our clinical development plans align with the company’s objectives and regulatory requirements.
- Clinical Trials Management: Lead the execution of phase 2 and 3 clinical trials, collaborating closely with cross-functional teams, including clinical operations, regulatory, pharmacovigilance, and other relevant departments.
- Patient Safety Oversight: Monitor the safety of subjects participating in clinical trials, ensuring strict adherence to eligibility criteria and ethical standards.
- Investigator Engagement: Actively engage with investigators to provide expert guidance on protocol design, procedural aspects, and strategies for patient recruitment and retention.
- Regulatory Submissions: Lead the clinical aspect of regulatory submissions, including Investigational New Drug (IND) applications, Investigational Brochures (IBs), Clinical Trial Applications (CTAs), Biologics License Applications (BLAs), and other necessary documentation.
- Scientific Communication: Contribute to the authorship of abstracts and manuscripts for publication, based on clinical trial results. Present data and scientific information to various levels within the organization.
- Business Development Support: Participate in identifying and evaluating potential business development opportunities that align with the company’s strategic goals.
REQUIREMENTS Education: - MD degree required.
- Board certification in Rheumatology or Neurology highly desired.
Experience: - Minimum of 5+ years of clinical research experience, required.
- Clinical trial experience in autoimmune indications in an industry setting (e.g., pharmaceutical, biotech, or CRO), strong preferred.
Skills: - 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 or in the office. Occasionally called upon to work hours in excess of your normal daily schedule. Travel 10-15% for conferences, site visits, etc.
COMPENSATION & 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.
Job tags
Salary
