Asset Team Lead, Clinical Development
Clinical Development | Remote in South San Francisco, CA | Full Time
Allogene Therapeutics is a clinical-stage biotechnology company with a single-minded focus on pioneering the development of investigational allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer. Led by world-class management with significant experience in cell therapy, our fully integrated, in-house team of researchers is dedicated to discovery and translational research, development, and cell manufacturing.
At Allogene, we are developing a pipeline of off-the-shelf CAR T cell candidates, with the goal of delivering readily available cell therapy faster, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.
The Asset Team Leader (ATL) position is accountable for developing and driving the Clinical Development strategy in alignment with the overall portfolio strategy of Allogene.
This individual will lead the Asset Team (AT) and is accountable for the seamless execution of all project deliverables up to the time the drug is marketed and beyond. The ATL will be responsible for, endorsing and integrating line function strategies, and is the single point of accountability for the seamless execution of program deliverables and decisions of the asset. The ATL leads presentations to relevant Governance committees and is ultimately responsible for the development and approval of program and/or project plans from the Asset Team.
The ATL applies Scientific Knowledge, Clinical and extensive Drug Development experience to ensure the Research and Development strategies of the AT can address clinical unmet need / improve the current standard of care for target oncology indications. The ATL will also be responsible for interfacing with external scientists as well as with internal Allogene experts to assure the swift identification of new early development opportunities to continuously optimize and refine the Development strategy. Together with the Asset Team Clinical Leads, the ATL will determine the clinical development plan that supports key deliverables and timely go-no go decisions to the next stage of development.
Reporting to the SVP, Head of Clinical Development, the Asset Team Lead:
- Leads matrixed global Asset Teams directly
- Together with Project Managers, manages timelines, team meeting agendas, scenario and risk mitigation planning, budget(s) for drug development programs and FTEs/PLM
- Acts as lead "voice" of the Asset Team and the program at internal Governance and with external Advisors
Responsibilities include, but are not limited to:
- Oversees clinical portfolio development from pre-FIH through to transition to late development to registration
- Leads cross functional Asset Team(s) composed of the following standing member line functions: Clinical lead, Clinical Operations Program lead, Research Project Lead, Project Manager, Translational Oncology Lead, Commercial Lead
- Endorses and integrates line function strategies into a consolidated Asset strategy
- Is accountable for developing projects that are cost-effective and looks to de-risk the candidate and investments as early as practical (clinical portfolio level)
- Establishes cross-functional relationships with leaders from key cross-functional lines: Pharmaceutical Sciences, Regulatory Affairs, Clinical Operations, Commercial, Program Management, etc.
- Leverages those relationships to manage key interdivisional interfaces on project issues including but not limited to Research, Development, Commercial, Manufacturing and Competitive Intelligence
- Contributes relevant Asset information to Pipeline & Prioritization Analyses
- Is accountable for ensuring that the projects are managed appropriately per budget
- Is accountable for ensuring that the necessary resources are available to the projects to support their success
- Is accountable for the quality of Asset deliverables to external authorities
- Promotes a culture of innovation within AT in order to bring forward creative development plans that maximize the potential of the asset
- Partners with Commercial leads to develop the "commercial case" for Asset development
- Partners with other ATLs to assure alignment of strategic and tactical approaches for AT oversight
- Leverages functional line expertise to achieve the team goals
- Acts as point of contact and project representative to governance and other decision-making bodies, including information dissemination and the resolution of critical project issues
- Serves as the Asset champion by negotiating and influencing key internal stakeholders
- Creates a motivated, committed and engaged project team
- Models and expects effective team behavior to achieve the project goals
- Serves as a coach/ mentor to Asset Team members
- Ensures the Asset Team adheres to relevant GXP requirements
- Collaborates with other ATLs to ensure consistency of processes across Asset Teams
Position Requirements & Experience:
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
Candidates with post-graduate clinically focused training/clinical development experience, and experience in clinical trial medicine and drug development with the following qualifications and skills:
- Medical degree required. Board certification in hematology or oncology preferred. Cell therapy experience will be a plus..
- Minimum of 10 years of relevant post graduate experience in the pharmaceutical, academic and/or medical research environments having successfully executed a major component of a development program(s) such as registration of drugs
- Strong understanding of all the elements of oncology drug development pre-clinical and clinical programs and experience in their design and execution
- Demonstrated experience in review, filing and defense of IND's, CTA's and full dossiers
- Demonstrated experience in successfully leading teams:
- Running them effectively, efficiently and on target in alignment with Departmental and Corporate goals and budgets
- Capable of recognizing when team interventions are required to enhance team effectiveness
- Knowledgeable of the Commercial and Environmental issues that drive drug development projects
- Demonstrated experienced in managing budgets and demonstrated fiscal responsibility
- Demonstrated experience working in a matrix environment in a biotechnology or pharmaceutical company.
- Demonstrated experience in GXP (especially GCP, GLP) and experience working in a regulated environment dealing with Regulatory Inspection Readiness
As an equal opportunity employer, Allogene is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment and internships designed to create a stronger and better Allogene that is focused on developing life-changing products for patients.