Executive / senior industry position
Allogene is seeking a leader to build and oversee the Translational Science (TS) function. The leader of TS will have a pivotal role in creating a novel TS capability in the cell therapy space, incorporating well understood and emerging biotechnology analytics with first in class cellular and molecular methods. The position will be responsible for oversight and management of external test labs performing GCLP and exploratory research-based bioassays as well as the design and build out of the internal TS function and systems. The role will entail operating in a fast-paced, highly dynamic environment with key company work partnerships including both internal and external stakeholders. Excellent communication skills and demonstrated ability to work well with others will be essential. The leader will report to the Chief Development Officer.
Responsibilities include, but are not limited to:
- Provides functional leadership including hiring and managing a professional, high performing TS team designed to meet the technical and compliance requirements of a growing company
- Establish necessary laboratory systems and documentation (e.g. SOPs) to perform TS bioassays in an effective and compliant manner
- Oversight and management of contract test labs performing GCLP and exploratory research-based bioassays
- Manage the transfer and validation of methods from contract-test labs (validation of methods and tech transfer of methods, including comparability)
- Manage and oversee systems to ensure compliance with documented policies
- Prepare data packages, technical reports, and relevant CTD sections in support of regulatory agency submissions
- Provide strategic leadership for TS on project teams
- Develop and approve method qualification/validation protocols and reports
- Develop and implement annual research plans, product project plans, departmental goals, action plans, and budgets
- Independently report metrics to executive management through Management Review process.
- Drive continuous improvement
- Externally collaborate with contract service providers and corporate partners
- Other duties as assigned
- PhD and/or MD in relevant field of biomedical research.
- A senior researcher with 20+ years of relevant industry or academic experience in all phases of drug development and with extensive experience in translational science and at least 5 years in a related management role, leading technical staff
- Education, training, or experience in cell and gene therapy a plus
- A recognized expert in drug development and forward and reverse translational science
- Well versed in various analytical techniques such as FACS, ELISAs, PCR, FTIR, UV and Fluorescence spectroscopy, and other applicable methods to the testing of biopharmaceuticals
- Experience with setting up and successfully managing cell-based assays is highly preferred
- Working knowledge of GCLP quality systems, regulatory requirements, and relevant guidance documents
- Working knowledge of LIMs applications and experience with implementing LIMS in the TS environment
- Excellent understanding of clinical development and regulatory processes and demonstrated ability to work with regulatory health authorities
- Must be able to collaborate and work with other departments such as Clinical, Commercial, Finance, Research & Development, Manufacturing, and Supply/Purchasing
- Ability to work in a fast-paced, start-up environment
- Ability to work independently and as part of a team
- Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously
- Strong interpersonal skills including relationship building, conflict resolution, and verbal and written communication are essential in this collaborative work environment
- Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines
- Candidates must be authorized to work in the U.S.
As an equal opportunity employer, Allogene Inc. 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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact the careers email at www.allogene.com for assistance.