Biologics & Immunogenicity Clinical Assay Lead

Position Purpose

As a member of Clinical Bioanalytics within Translational Clinical Sciences the Biologics & Immunogenicity Clinical Assay Lead will play a critical role in supporting clinical strategies in all stages of drug development and post marketing activities through scientific and technical leadership oversight and management of external and internal partners involved in delivering quality timely and regulatory compliant PK PD and/or immunogenicity bioanalytical assays and data.

Organizational Relationships

• Reports to Biologics and Immunogenicity Group Lead or Small Molecule Clinical Assay Lead with supervisor responsibilities Clinical Bioanalytics within Translational Clinical Sciences.

• Frequent interaction with colleagues in Translational Clinical Sciences Clinical Medicines or Biomedicines Design (PDM/BMD) Clinical Operations Data Management Statistics Regulatory and Finance as appropriate.

• Frequent interaction with bioanalytical Contract Research Organizations (CROs) Central Laboratories and as appropriate external collaborators.

• Member of Clinical sub-teams and study teams.

Primary Responsibilities

• Serves as a member of the clinical study team and bioanalytical subject matter expert for executing clinical study setup & conduct contributing to the study protocol development & review preparing submissions addressing regulatory queries implementing bioanalytical strategies & assays and delivering regulatory compliant data and reports within program timelines.

• Leads and oversees large molecule PK PD and immunogenicity (ADA and Nab) assay lifecycle management from early stage to registration encompassing executing analytical strategy development and method design validation data quality review corresponding sample analyses & reporting to meet evolving program objectives and regulatory expectations. Assists CROs with effective troubleshooting of the bioanalytical assay and issue resolution.

• Functions as key point of contact with external & internal laboratories and supports (or leads as appropriate) selection qualification performance evaluation and periodic visits and audits of CRO laboratories conducting clinical PK PD and immunogenicity assays (as relevant to the role).

• Supports the clinical trial conduct within scope of the Clinical Bioanalytics responsibilities including development and review of documents and processes such as CRF and data setup clinical site lab manual sample management & reconciliation bioanalytical study planning & reporting budgeting & invoicing compliance with clinical SOPs & policies and regulatory inspection readiness & conduct.

• Contributes to the development of Best Practices processes templates and policies.

• Maintains up-to-date knowledge of current and novel ligand binding technologies & techniques global regulatory guidance & expectations and industry best practices.

• As appropriate additional responsibilities may include the following:

• Leads development of novel complex methodologies troubleshooting & resolution of complex technical & logistical issues with vendors and study teams. Identifies technology/capabilities gaps and proposes mitigation strategies including development of novel technical capabilities with vendors. Scientifically evaluates complex data (i.e. evaluates aberrant results and data trends) anticipates and corrects potential issues and able to appropriately guide study teams through complex issues resolution.

• Leads internal and cross-functional organization initiatives best practices and demonstrates internal and external influence.

• Provides subject matter expertise guidance and mentoring to colleagues. May have responsibility for dotted/direct line management of staff.

Qualifications

Must Have

• PhD or equivalent in biology or analytical chemistry/chemistry with 2 to 6 years of experience

• M.S with 3 to 6 OR B.S. with 7 to 10 years of relevant industry experience.

• Minimum of 5-8 years of industry or bioanalytical experience with PK and/or immunogenicity assay development validation and sample analyses ligand binding (ELISA and ECL) methodologies.

• Working knowledge of GxP regulations governing conduct of clinical trials and regulatory guidance and expectations relevant to regulated bioanalysis.

• Subject matter expert in regulated bioanalysis of Biologics and understanding of bioanalytical techniques commonly used for Biomarkers.

• In depth knowledge of GxP regulations governing conduct of clinical trials and regulatory guidance and expectations relevant to regulated bioanalysis.

• Demonstrated ability to think strategically work in a highly matrixed environment and execute multiple projects simultaneously.

• Highly effective communication skills: verbal written and presentation.

Nice to Have

• Demonstrated CRO management and outsourcing experience.

• Experience with regulatory inspections.

• Experience preparing regulatory submissions and addressing regulatory queries.

• Understanding of clinical trial design and overall principles of clinical development and related disciplines (e.g. pharmacokinetics and clinical pharmacology statistics ADME formulation and drug product).

• Prior experience with training mentoring or managing colleagues.

• Hands-on experience with the development validation and troubleshooting of the methods for PK and immunogenicity (including the determination of assay cut points tolerance and sensitivity along with experience implementing ACE BEAD and SPEAD methodologies) and clinical sample analysis.

• Hands-on experience with the development validation and troubleshooting of LC/MS quantitation of large molecules and immunocapturing hybrid assays.

• Understanding of critical reagent generation & lifecycle management

• Experience with biosimilars gene therapy multi-domain therapeutics immunocapture protein binding cell-based assays and technologies such as RT-PCR qPCR ELISPOT AMS and FACs.

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.

Other Job Details

• Work Location Assignment:On Premise

Relocation assistance may be available based on business needs and/or eligibility.