PRIMARY OBJECTIVE: The Senior Scientist position is open to highly motivated and innovative candidates with a Ph.D. degree, a successful post-doctoral fellowship and a minimum of 7 years of experience working in the biotechnology or pharmaceutical industry setting. The incumbent will be part of the Biomarker and Bioanalysis Group within Translational Sciences within Translational Sciences responsible for biomarker strategies for clinical trials.
ABOUT ARCELLX: Arcellx (http://www.arcellx.com/) is a venture-backed, early-stage biotech company focused on the development of novel cell-based cancer therapies. The company is located in Gaithersburg, Maryland and has assembled a team of biotechnology professionals with expertise in biologics discovery, characterization, and development. Lead products will incorporate proprietary technologies that enhance tumor-specific killing by genetically engineered human immune cells.
The main responsibilities will include but are not limited to:
- Contribute to developing bioanalytical strategy and methods to support biomarker, pharmacokinetics and pharmacodynamics, and immunogenicity assessments of clinical drug candidates.
- Responsible for data analysis and interpretation to characterize PK profiles of clinical drug candidates and PK/PD modeling and simulation in support of dose selection and projections.
- Contribute to design of PK experiments and preparation of pre-clinical and clinical PK reports. Contribute to IND applications, clinical protocols and other regulatory documents.
- Collaborate with discovery, preclinical development, process development, regulatory and clinical teams to accelerate product pipelines.
- May supervise research associates.
- PhD in Pharmacology, Clinical Pharmacology, Immunology or related fields. Experience in characterizing pharmacokinetic and pharmacodynamic properties of cell therapy and biologic drug products.
- Experience and knowledge of CAR T therapies in clinical stages is preferred.
Significant experience in PK/PD modeling, dose-response and exposure-response analyses and human dose projections.
- Experience with PK modeling and analysis software Phoenix WinNonlin and other PK/PD software.
- Strong scientific background and hand on experience with clinical bioanalytical assay development and validation. Expert in PK and immunogenicity assays.
- Commitment to ethical scientific investigations and rigorous experimental methods.
- Ability and desire to multitask and function in a fast-paced entrepreneurial environment.
- Demonstrated experience working on a multi-disciplinary team and ability to integrate cross-functional information.
- Strong written and oral communication skills necessary to report on and deliver scientific presentations.
- Demonstrated ability to think critically and analyze and interpret data independently.
- Sense of urgency in performance of duties.
- Interpersonal skills that promote a collaborative and productive lab 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.