Senior Science Officer, Clinical Development

Background

The California Institute for Regenerative Medicine (CIRM) is the state’s Stem Cell Agency. We were created by the voters of California when they approved Proposition 71 in 2004, and renewed when Proposition 14 was approved in 2020, providing $5.5 billion to invest in stem cell research in California. CIRM’s mission, to accelerate world-class science to deliver transformative regenerative medicine treatments in an equitable manner to a diverse California and world, is what drives us to succeed every day.

To meet this challenge, our team of highly trained and experienced professionals actively partners with both academia and industry in a hands-on, entrepreneurial environment to fast-track the development of today’s most promising stem cell and regenerative medicine technologies. 

CIRM is the world’s largest institution dedicated to helping people by bringing the promise of regenerative medicine closer to reality. 

General Statement

The mission of the Clinical Development Team is to attract and support the most innovative and high-quality stem cell and genetic therapy-based clinical projects for CIRM funding. We aim to advance cutting-edge science and drive transformative breakthroughs in regenerative medicine. Our primary goals include supporting and accelerating the clinical and pre-commercial development of regenerative medicine therapies from first-in-human studies to readiness for submission of marketing approval applications. To support clinical development of stem cell and genetic therapy-based therapies, CIRM also supports critical research infrastructure such as the CIRM Alpha Clinics Network and the CIRM Manufacturing Network.

Role Summary: 

The Senior Science Officer, Clinical Development, will help manage a portfolio of clinical trial project awards, will assist in coordinating the activities of the CIRM Manufacturing Network, will provide clinical operations subject matter expertise across all relevant CIRM programs and will interface with the Patient Access Team for Clinical Infrastructure support. In this role, the Senior Science Officer will work cross-functionally with the Clinical Development, Preclinical Development, Patient Access, Grants Management and Review Teams within CIRM. 

The Senior Science Officer will have expertise and experience in a scientific research discipline, preferably one that relates to stem cells, cell and gene therapies, or drug or device preclinical and clinical development. The Senior Science Officer will have extensive experience in the design and operation of clinical trials.

The Senior Science Officer will have an innate sense of urgency and determination to deliver outstanding results and to find innovative ways of meaningfully advancing CIRM's mission.

Job Functions

In the position you will be accountable for:

Managing a Portfolio of Clinical Trial Stage Award

• Work in a team environment in advancing the most promising clinical stage stem cell-based and genetic therapies for unmet medical needs.
• Manage the development of project milestones and contracting of awarded clinical trial stage projects.
• Monitor the programmatic, scientific and/or technical progress of an awarded clinical trial stage project, supporting milestone achievement in a timely manner.
• Assess the progress of projects through objective metrics and ensuring complete and up-to-date reporting on all projects in your portfolio.
• Work with the project teams to proactively identify risks or deficiencies with active projects and leveraging internal and external resources to ensure success.
• Leverage internal and external resources to ensure success, or recommend appropriate action to suspend/discontinue projects when warranted.
• Seek new and innovative ways to improve and accelerate the therapies through clinical development.
• Monitor resources to ensure they are being used appropriately and efficiently.
• Work with CIRM colleagues to support a highly competitive review process to ensure only the most promising and well-constructed projects are considered for inclusion in the Clinical Development portfolio

 Supporting Manufacturing Needs Across the CIRM Portfolio

• Support operationalization of the CIRM Manufacturing Network by coordinating collaborations and partnerships between academic and industry stakeholders toward shared goals of advancing stem cell and genetic therapy manufacturing and building a diverse highly skilled manufacturing workforce.
• Support the development and management of CIRM Manufacturing Network funding opportunities and managing individual awards.
• Evaluate manufacturing plans of CIRM-funded preclinical and clinical stage projects and working collaboratively with CIRM team members, project teams and external stakeholders to address manufacturing risks and bottlenecks

Leveraging CIRM Clinical Infrastructure to Support Clinical Development Projects

• Work collaboratively with CIRM Patient Access Team to increase patient access to CIRM-funded therapies.
• Work collaboratively with CIRM Patient Access Team to leverage CIRM Clinical Infrastructure Programs for accelerating clinical development of CIRM-funded therapies.

Building, Advancing, and Communicating the Portfolio

• Be up to date on trends and key developments in the stem cell and gene therapy research field
• Seek new and innovative ways to improve on the conduct of science
• Help to connect scientists with potential collaborators, resources or programs that would advance an important scientific project or direction
• Collect data and helping to track progress across CIRM-funded portfolios to inform priorities and alignment of ongoing and future funding opportunities; creating and maintaining slides for reporting portfolio to different stakeholders and CIRM leadership
• Contribute to the planning and organization of CIRM-sponsored webinars, scientific workshops and grantee/trainee conferences
• Work with CIRM colleagues to improve existing concepts and inform the development of new concepts for advancing clinical and manufacturing programs
• Represent CIRM and the Clinical Development team at appropriate scientific, medical, governmental, and industry meetings and events.
• Engage with all stakeholders (scientific thought leaders, subject matter experts, patient advocacy groups) to build support for and advance project
• Work with colleagues to promote, support, and disseminate information about Clinical Development and Manufacturing programs and related activities to the public and other stakeholders, as appropriate

Harmonizing with the CIRM Mission

• Demonstrate commitment to CIRM’s mission in your words and actions
• Collaborate with others to generate efficiencies, enhance productivity, and develop competencies
• Develop and organizing internal guidance and SOP documents for CIRM processes in collaboration with other CIRM teams
• Show commitment to team decisions by supporting and working to achieve team objectives.

Supervision Received

 The Senior Science Officer reports to the Senior Director of Clinical Development.

Supervision Exercised

 None

Qualifications (Experience and Education)

• Doctorate (PhD, PharmD, MD/DO,) in medicine, biomedical research or a related area with 6 years or more of work experience in a science-related discipline beyond doctoral degree, OR
• Master’s Degree in biomedical research or a related area at least 9 years work experience in a science-related discipline
• 3 years of demonstrated management experience in leading preclinical development, clinical development and/or manufacturing of stem cell-based therapies or genetic therapies
• 2 years successful demonstrated experience leading independent projects/programs (e.g., principal investigator on academic research project or leading function of program(s) at a non-academic organization) 

Desirable Skills and Abilities

• Strong knowledge of drug development, manufacturing process and regulatory for stem cell-based therapies and   genetic therapies.
• Proven track record in leading 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.
• Outstanding communication skills.
• Ability to work collaboratively in a team 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 2 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.

Salary Range

This position is expected to pay $154,891 - $174,438 which fits within the full salary range of $154,891 - $201,431. 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.

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 contact jobs@cirm.ca.gov.

Benefits

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

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.

Salary : $154,891 - $174,438