Preclinical Writer Jobs (NOW HIRING)

Background

The California Institute for Regenerative Medicine (CIRM) is a state agency created by California voters to accelerate stem cell and gene therapies for people with unmet medical needs. Since 2004, Californians have entrusted CIRM with $8.5 billion to accelerate promising discoveries through clinical trials, train a regenerative medicine workforce, strengthen the state's biotechnology economy, and expand access to transformative treatments. Today, CIRM is pioneering new models of therapy development and accelerating medical breakthroughs that change lives - in California and around the world. For more information, visit www.cirm.ca.gov.

General Statement

The mission of the Preclinical Development team is to attract and rapidly advance the most promising stem cell-based and genetic therapies through preclinical development into early-stage clinical trials for diseases affecting Californians.

Job Functions

Portfolio & Award Management

• Manage a portfolio of preclinical stage awards from early development through IND-enabling activities
• Ensure projects are aligned with CIRM's mission, milestones, and timelines
• Identify scientific, technical, regulatory, and operational risks early and implement mitigation strategies
• Advise grantees on:
  • Experimental design and data robustness
  • CMC development and manufacturability considerations
  • Regulatory strategy and IND-enabling requirements
  • Stage-appropriate access strategy
• Support progression of projects toward key milestones (e.g. pre-IND, IND clearance, trial startup)

Program Development & Execution

• Contribute to the development and implementation of funding programs that support preclinical development of stem cell-based and genetic therapies
• Help define program scope, eligibility, and success criteria in collaboration with Review, Operations, and leadership
• Support continuous refinement of PDEV programs based on portfolio insights and field evolution
• Mentor team members in program design and applicant engagement
• Provide scientific and portfolio insights to inform continuous refinement of PDEV programs and funding strategies

Cross-Functional Integration

• Collaborate with Clinical Development and/or external partners to facilitate transition of promising programs into clinical development
• Collaborate with Discovery to identify and shape high-potential projects for translation
• Collaborate with Patient Access to incorporate early considerations of feasibility, delivery, and eventual patient access and impact
• Coordinate with R&D Data Infrastructure on data standards, DSMP expectations, and translational data quality
• Help break silos and ensure continuity across the full development pipeline

External Engagement & Thought Leadership

• Represent CIRM in scientific, industry, and regulatory forums
• Engage with external experts, partners, and stakeholders to identify emerging opportunities and challenges
• Provide insight on ecosystem gaps (e.g., manufacturing, delivery, regulatory pathways, technology platforms)
• Contribute to shaping CIRM's role as a leader in translational and preclinical development in regenerative medicine

Qualifications

• PhD, MD or equivalent in relevant scientific discipline
• Minimum 5 years of experience beyond doctoral degree, in preclinical/translational development in biotech, pharma, or academia

• Demonstrated experience advancing programs through key preclinical and translational development milestones (IND-enabling stages), preferably in cell and/or genetic therapy
• Strong understanding of:

• • Preclinical development strategy
  • CMC and manufacturing considerations
  • U.S. regulatory requirements and pathways for progressing therapeutic candidates toward IND submission and clearance
• Experience critically evaluating scientific data, development plans, timelines and program risks across multiple therapeutic programs
• Ability to identify and prioritize scientific, technical, regulatory, and operational challenges and develop practical solutions
• Experience working in multidisciplinary and cross-functional environments
• Strong written and verbal communication skills, including the ability to communicate complex scientific concepts to diverse audiences
• Strong organizational, analytical, and project management skills
• Experience fostering a collaborative team environment by prioritizing shared goals, maintaining accountability, and supporting group decisions.

Desired Skills/Abilities

• Direct experience participating in FDA meeting package preparation and in subsequent attendance at formal meetings.

• Strong knowledge of drug development, manufacturing process and regulatory for stem cell-based therapies andgenetic therapies.
• Proven track record of collaborating cross-team collaboration to deliver high-quality outcomes.
• Ability to effectively manage, organize and prioritize multiple projects and meet deadlines in a fast-paced and demanding environment.
• Ability to make clear, concise and impactful presentations.
• Ability to embrace change and a desire to learn.

Working Conditions

• Hybrid environment, required to work two days in the South San Francisco office and three days remotely. In-person attendance of organizational meetings and board, subcommittee, and working group meetings as required.
• Prolonged periods of sitting at a desk and working on a computer.
• Must be willing to work in a high-rise building.
• Ability to operate standard office equipment.
• Be available to work outside of normal business hours.
• Require occasional travel for work-related events.

Supervision Received

TheSenior Science Officer Ireports directly to theSenior Directorof Preclinical Development.

Supervision Exercised

None

Compensation

This position is expected to pay$154,891 - $176,976, which fits within the full salary range of $154,891 - $207,480 for the Senior Science Officer job classification. It is uncommon for an individual to be offered a salary close to the upper end of the full range for a position. Salary for this position will reflect the final candidate's qualifications, experience, skills, knowledge, relevant education, and certifications, in addition to being aligned with the internal leadership peer group.

Benefits

https://benefits.calhr.ca.gov/state-employees/

Required Application Documents

Applicants must submit a resume and cover letter to be considered for this position.

Applicants requiring reasonable accommodations for the interview process should inform the interview scheduler at the time of scheduling.

For general questions regarding this position or inquiries specifically related to reasonable accommodations or Equal Employment Opportunity (EEO), please contactjobs@cirm.ca.gov.

Additional EEO Contact Information

California Relay Service: 1-800-735-2929 (TTY), 1-800-735-2922 (Voice) TTY is a Telecommunications Device for the Deaf and is reachable only from phones equipped with a TTY Device.

Equal Opportunity Employer

The State of California is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding and related medical conditions), and sexual orientation.