Head of Translational Science
ABOUT ARCELLX: Arcellx is a clinical-stage biopharmaceutical company developing novel, adaptive and controllable cell therapies for the treatment of patients with cancer. The Company's vision is to expand access to cell therapies to millions of patients under the care of academic and community practices. The company is in Gaithersburg, Maryland and has assembled a team of biotechnology professionals with expertise in biologics discovery, characterization, and development.
Arcellx is searching for a dynamic senior leader to build the Translational Science function and drive the influence of this critical capability through R&D. This team is responsible for leading the transition of the organization's drug discovery pipeline into early-stage clinical development with a goal to design correlative studies that will support the evaluation of safety, pharmacokinetics, and on-target activity of novel cellular therapies. The head of Translational Science will work closely with Research and Clinical to provide guidance on clinical indications, biomarkers, dosing strategies, combinations, and other aspects of drug development strategy. The successful candidate will work collaboratively across functional areas such as Clinical, Research and Regulatory as well as with a network of external KOLs and CROs to advance our growing development pipeline of innovative cell therapies.
The main responsibilities will include but are not limited to:
- Build and provide leadership to the Histopathology, Biomarker and Bioanalysis, Pharmacokinetics and Translational Science Strategy groups.
- Conceive and execute translational strategies to support advancing discovery projects into clinical development programs, providing the link between early research and the clinic.
- Oversees the development of detailed work plans that lead to the incorporation of quantitative, objective end points into clinical studies to aid in patient selection and to demonstrate target engagement, pharmacodynamic activity, and pharmacokinetics of both biologic and cellular components.
- Contributes to relevant regulatory interactions and documents.
- Develops, manages and implements operating budget for Translational Sciences, ensuring that financial resources are effectively allocated and managed to support achievement of the strategic objectives.
- Nurture a culture of engagement, respect and high performance within a team environment. Provide leadership, coaching and feedback. Mentors and empowers personnel.
- MD, PhD, DVM or equivalent with 10+ years of biopharmaceutical/ biotech industry experience and a demonstrated leadership across more than one translational science discipline (pathology, toxicology, pharmacokinetics, clinical pharmacology, bioanalysis, bioinformatics, and/or biomarker discovery).
- Must have experience in oncology drug development in an industry setting.
- Solid scientific understanding of the complexities and recent developments in cell therapy and the ability to apply knowledge to drug development.
- Knowledge of biomarker development and implementation to support clinical assay development/validation for pharmacokinetics, mechanism of action, proof of biologic activity, patient stratification and response prediction markers for early, mid and late-stage oncology clinical trials.
- Good understanding of relevant areas of biology, pathology, biostatistics, regulatory, clinical pharmacology, pre-clinical toxicology, pharmacogenomics and biomarker-based approaches.
- Proficiency in emerging diagnostic and predictive biomarker technologies
- Significant exposure to relevant regulatory affairs including IND and/or BLA submission and FDA advisory committee meetings.
- Demonstrated experiences highlighting collaboration and influence across internal and external stakeholders, including substantial experience in alliance management
- Effective leadership bringing people, process and ideas together to unlock potential, fueling growth and maximizing impact
- Ability to influence, inspire, and motivate others to participate and take action
- Demonstrated effective interpersonal, communication and negotiation skills for a wide variety of audiences
- Courage to lead and make tough decisions
- Ability to use knowledge, skills, and perspectives to be able to promote innovation that can benefit the company and produce reliable outcomes.
- Identifies what needs to be done and does it before the situation requires it
- Possess strong problem solving and analytical skills and be an independent and creative thinker.
- Ability to navigate a fast-paced, highly matrixed work environment.
Without exception, applicants must submit both a cover letter and resume to be considered for these positions and must have experience in one of the fields listed above.