Senior Science Officer Clinical Development

Background

The California Institute for Regenerative Medicine (CIRM) is the states 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. CIRMs mission to accelerate worldclass 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 handson entrepreneurial environment to fasttrack the development of todays most promising stem cell and regenerative medicine technologies.

CIRM is the worlds 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 highquality stem cell and genetic therapybased clinical projects for CIRM funding. We aim to advance cuttingedge science and drive transformative breakthroughs in regenerative medicine. Our primary goals include supporting and accelerating the clinical and precommercial development of regenerative medicine therapies from firstinhuman studies to readiness for submission of marketing approval applications. To support clinical development of stem cell and genetic therapybased 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 crossfunctionally 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 CIRMs 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 cellbased 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 uptodate 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 wellconstructed 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 CIRMfunded 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 CIRMfunded therapies.
• Work collaboratively with CIRM Patient Access Team to leverage CIRM Clinical Infrastructure Programs for accelerating clinical development of CIRMfunded 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
• Collectdata and helping to track progress across CIRMfunded 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 CIRMsponsored 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 CIRMs 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 sciencerelated discipline beyond doctoral degree OR
• Masters Degree in biomedical research or a related area at least 9 years work experience in a sciencerelated discipline
• 3 years of demonstrated management experience in leading preclinical development clinical development and/or manufacturingof stem cellbased 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 nonacademic organization)

Desirable Skills and Abilities

• Strong knowledge of drug development manufacturing process and regulatory for stem cellbased therapies and genetic therapies.
• Proven track record in leading crossteam collaboration to deliver highquality outcomes.
• Ability to effectively manage organize and prioritize multiple projects and meet deadlines in a fastpaced 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. Inperson 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 highrise building.
• Ability to operate standard office equipment.
• Be available to work outside of normal business hours.

Salary Range

This position is expected to pay$154891 $174438 which fits within the full salary range of $154891 $ 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 candidates 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.

Benefits

EEO Contact Information

California Relay Service:(TTY)(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 creedsex (includes pregnancy childbirth breastfeeding and related medical conditions) and sexual orientation.