Director, Integrated Bioanalysis Oncology Development

This role sits at the heart of Integrated Bioanalysis, driving end-to-end bioanalytical strategies that shape the future of our Oncology portfolio. The position leads the design and implementation of robust approaches for PK, immunogenicity and biomarker endpoints, ensuring assays are developed, validated and applied in line with their context of use. Working closely with internal laboratories and external CRO partners, the role provides scientific oversight across multiple modalities and stages of development.

Acting as IBA project lead on selected programs, this role partners with cross-functional teams to align on strategy, manage expectations and deliver high-quality data that informs key decisions. The role offers the chance to influence a diverse pipeline, contribute to departmental strategy and help advance life-changing medicines for patients with cancer. Based at one of our US research hubs in Gaithersburg, MD or Boston, MA, this role leads integrated bioanalytical strategy and delivery for selected Oncology programs.

The role partners with TA leads and stakeholders across Clinical Pharmacology and Safety Sciences, Translational Medicine, Research and Clinical Development to ensure timely, fit-for-purpose bioanalytical support. Key responsibilities include:

• Defining and driving bioanalytical plans for complex modalities such as ADCs, radio-conjugates, T cell engagers, biologics, cell therapies and small molecules.
• Maintaining strong scientific oversight of internal and external laboratory execution.
• Engaging with CROs on assay transfer, validation and study conduct.
• Interpreting complex datasets and communicating clear conclusions to project teams.
• Interacting with global Health Authorities: contributing to regulatory submissions, addressing questions and mitigating risk across geographies.
• Representing IBA at internal and external forums, publishing scientific work and helping shape strategic initiatives.
• Encouraging collaboration across matrixed teams, promoting knowledge exchange and ensuring resources are prioritized effectively across multiple concurrent projects.

Required Qualifications and Experience:

• Master’s in immunology, molecular biology, or related studies with minimum of 10+ years relevant experience.
• PhD in immunology, molecular biology, or related studies with minimum of 7+ years relevant experience in biopharmaceutical industry.
• Confirmed experience as a subject matter expert in regulated bioanalysis across a range of modalities (PK/PD and immunogenicity assessments).
• Experienced in regulated bioanalysis with in-depth knowledge of complex biologics and/or bioanalysis of ADCs and related modalities.
• Skilled scientist able to discern the advantages of a range of analytical techniques such as ligand binding assays, LC-MS, molecular assays (ddPCR, qPCR, RT-qPCR), flow cytometry, ELISpot, viral assays, cytokine assays.
• Deep understanding of global regulatory expectations and guidance in relevant areas.
• Outstanding verbal and written communication skills.

Desired Skills and Experience:

• T cell engagers, monoclonal Abs, ADCs, other biologics and/or small molecules experience is desired.
• Strong scientific background in immunology, ability to support drug programs across multiple therapeutic areas.
• Experienced in partnering with operational functions within bioanalysis, clinical operations, external CROs to develop efficient processes for bioanalytical execution.

The annual base pay for this position ranges from $175,498.40 to $263,247.60. Our positions offer eligibility for various incentives - an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the plan.