Senior Science Officer, Clinical Development (South San Francisco, CA) (San Francisco)

Senior Science Officer, Clinical Development (South San Francisco, CA)

The Senior Science Officer, Clinical Development, will help manage a portfolio of clinical trial project awards, assist in coordinating the activities of the Client Manufacturing Network, provide clinical operations subject matter expertise across all relevant Client programs, and interface with the Patient Access Team for Clinical Infrastructure support. This role involves working cross-functionally with Clinical Development, Preclinical Development, Patient Access, Grants Management, and Review Teams within Client.
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. Extensive experience in the design and operation of clinical trials is required.
An innate sense of urgency and determination to deliver outstanding results and to find innovative ways of meaningfully advancing Client’s mission is essential.

Job Functions
In this position, you will be accountable for:

Managing a Portfolio of Clinical Trial Stage Awards

• Work in a team environment to advance 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 awarded clinical trial stage projects, supporting milestone achievement in a timely manner.
• Assess the progress of projects through objective metrics and ensure complete and up-to-date reporting on all projects in your portfolio.
• Work with project teams to proactively identify risks or deficiencies with active projects and leverage 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 therapies through clinical development.
• Monitor resources to ensure they are being used appropriately and efficiently.
• Work with Client 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 Client Portfolio

• Support operationalization of the Client 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 Client Manufacturing Network funding opportunities and manage individual awards.
• Evaluate manufacturing plans of Client-funded preclinical and clinical stage projects and work collaboratively with Client team members, project teams, and external stakeholders to address manufacturing risks and bottlenecks.

Leveraging CLIENT Clinical Infrastructure to Support Clinical Development Projects

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

Building, Advancing, and Communicating the Portfolio

• Stay 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.
• Connect scientists with potential collaborators, resources, or programs that would advance important scientific projects or directions.
• Collect data and track progress across Client-funded portfolios to inform priorities and alignment of ongoing and future funding opportunities; create and maintain slides for reporting portfolio to different stakeholders and Client leadership.
• Contribute to the planning and organization of Client-sponsored webinars, scientific workshops, and grantee/trainee conferences.
• Work with Client colleagues to improve existing concepts and inform the development of new concepts for advancing clinical and manufacturing programs.
• Represent Client 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 projects.
• 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 Client Mission

• Demonstrate commitment to Client’s mission in your words and actions.
• Collaborate with others to generate efficiencies, enhance productivity, and develop competencies.
• Develop and organize internal guidance and SOP documents for Client processes in collaboration with other Client teams.
• Support and work 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 the doctoral degree, OR
• Master’s Degree in biomedical research or a related area + at least 9 years of 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 of 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 processes, and regulations 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.

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