What are the responsibilities and job description for the Senior Science Officer, Clinical Development (South San Francisco, CA) position at CEDENT?
The Senior Science Officer, Clinical Development, will help manage a portfolio of clinical trial project awards, will assist in coordinating the activities of the Client Manufacturing Network, will provide clinical operations subject matter expertise across all relevant Client 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 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. 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 Client’s mission.
Job Functions
In the position you will be accountable for:
Managing a Portfolio of Clinical Trial Stage Award
The Senior Science Officer reports to the Senior Director of Clinical Development.
Supervision Exercised
None
Qualifications (Experience and Education)
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 Client’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 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
- 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 managing individual awards.
- Evaluate manufacturing plans of Client-funded preclinical and clinical stage projects and working collaboratively with Client team members, project teams and external stakeholders to address manufacturing risks and bottlenecks
- Work collaboratively with Client Patient Access Team to increase patient access to Client-funded therapies.
- Work collaboratively with Client Patient Access Team to leverage Client Clinical Infrastructure Programs for accelerating clinical development of Client-funded therapies.
- 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 Client-funded portfolios to inform priorities and alignment of ongoing and future funding opportunities; creating and maintaining 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 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
- Demonstrate commitment to Client’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 Client processes in collaboration with other Client teams
- Show commitment to team decisions by supporting and working to achieve team objectives.
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)
- 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.
- 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.
