Pyxis Oncology is seeking a collaborative and dynamic Director, Bioanalysis to lead our Bioanalytical efforts within the Research function. The Director of Bioanalysis, reporting to the Head of Non-Clinical Research, will be responsible for managing the design, analysis, interpretation, transfer and reporting of the bioanalysis of pharmacokinetic data from preclinical and clinical studies in utilizing state-of-the-art methodologies, working closely with both internal and external parties. Additional responsibilities include assisting in preparing and reviewing bioanalytical plans, protocols and reports to meet regulatory requirements and management of bioanalytical activities (budgeting, auditing CROs, setting up agreements etc).
Travel: 5-10% of travel domestic/international
- Lead the development of BA strategy to meet current analytic needs by managing the implementation of bioanalytical contracts/SOW, plans, and reports to ensure that the BA data meet current/future regulatory and scientific requirements.
- Work with internal and external subject matter experts and other relevant disciplines to manage and resolve scientific, technical or quality issues and improve study consistency, quality, efficiency and effectiveness.
- Manage a ligand binding assay (LBA) and mass spectrometry scientist in developing bioanalytical assays for new and existing ADC programs for preclinical pharmacology, DMPK and Toxicology studies.
- Oversee the development and validation of bioanalytical assays (e.g., LC-MS/MS, ELISA, qPCR) for the quantitative analysis of small molecules, biologics, and biomarkers in various matrices.
- Assist with the coordination of all bioanalysis activities for individual preclinical/clinical programs to ensure alignment of BA data deliverables.
- When necessary, participate in day-to-day operation of BA work, including the analysis of samples and associated duties, processing of biological samples, ensure adequate levels of reference materials, control matrix, and project-specific consumables and resources, assist in method validation, and data processing/reporting, QC checking and data compilation, and basic operation and routine maintenance of laboratory equipment
- Instill and adhere to GLP and GCP regulations, relevant SOPs, protocols, policies and safety procedures.
- Demonstrate Pyxis Oncology values: be of service, be clever, be gutsy, be tenacious, and be you.
- Perform other related duties as required by position.
- PhD or MS in Bioanalytical Chemistry, Pharmaceutical Sciences, Pharmacokinetics or related discipline with minimum of 10 years of relevant industry experience required
- Good understanding of bioanalytical technology/methods both for small and large molecules with deep expertise in bioanalytical LC-MS/MS platforms to support PK/TK, efficacy in preclinical space required
- Excellent organization skills and be highly regarded in the in BA/PK area with a strong background with managing external CRO’s
- Strong leadership and team management skills, with a track record of successfully leading a team member.
- Well-grounded experience in drug development concepts – data driven decision making, functioning of project teams/sub-teams, development of protocols, clinical study reports etc.
- Ability to work in a dynamic team-oriented environment as demonstrated by participating in and contributing to cross functional teams
- Eligible to work in the United States without sponsorship
Compensation and Total Rewards Package:
The full-time annual base salary for this position is estimated to range between $185,000 to $230,000. The final compensation package offered to a successful candidate will consider a number of factors including but not limited to prior experience, relevant expertise, education, skills, qualifications and certifications, business needs, and market conditions.
Pyxis Oncology also provides eligible employees a comprehensive and competitive total rewards package including but not limited to a discretionary annual bonus (related to company and individual performance), equity, health insurance (including medical, dental, and vision), company paid life and disability insurance, unlimited vacation with paid holidays, a 401(k) plan, a flexible work model, and paid parental leave.
About Pyxis Oncology
Pyxis Oncology, Inc. is a clinical stage company focused on defeating difficult-to-treat cancers. The company is efficiently building next-generation therapeutics that hold the potential for mono and combination therapies. Pyxis Oncology’s therapeutic candidates are designed to directly kill tumor cells and to address the underlying pathologies created by cancer that enable its uncontrollable proliferation and immune evasion. Pyxis Oncology’s antibody-drug conjugates (ADCs) and immuno-oncology (IO) programs employ novel and emerging strategies to target a broad range of solid tumors resistant to current standards of care.