Director, Oncology Bioanalytical Strategy Lead

AstraZeneca · Cambridge Kendall SQ, MA

RoleLantern checked

CMCFull-timeCompany career page

The apply link worked recently (not employer-confirmed).

Role summary

Director-level position leading bioanalytical strategy for oncology programs within AstraZeneca's Integrated Bioanalysis Global Team. Responsible for designing and implementing robust bioanalytical strategies including pharmacokinetics, immunogenicity, and biomarkers to support pipeline advancement, with cross-functional collaboration and regulatory engagement.

What they're looking for

Bachelor's degree in immunology, molecular biology, or related field plus 10+ years relevant experience; or Master's degree plus 7+ years biopharmaceutical industry experience
Proven subject matter expertise in regulated bioanalysis across multiple modalities and therapeutic approaches
In-depth knowledge of complex biologics, antibody-drug conjugates, and bioanalytical methodology
Experience leading bioanalytical strategy as project lead in diverse teams and advancing portfolio programs
Proficiency with analytical techniques including ligand binding assays, LC-MS, molecular assays, flow cytometry, and immunoassays
Experience with assay transfer, CRO oversight, data interpretation, and preclinical/clinical study delivery
Knowledge of global regulatory expectations and contribution to IND, CTA, IB, and NDA/BLA submissions

What you'll be doing

Lead design and implementation of bioanalytical strategies for oncology portfolio programs including PK, immunogenicity, and biomarker endpoints
Serve as IBA project lead for selected programs, collaborating with internal and external laboratory teams on assay development and validation
Manage stakeholder expectations and serve as primary interface between bioanalytical scientists and cross-functional project teams
Engage with regulatory agencies across multiple countries on strategy mitigation, regulatory submissions, and authority responses
Contribute to scientific excellence through presentations, publications, and strategic department initiatives

Key requirements

Therapeutic area: Oncology

Privacy & handoff

This role links to AstraZeneca's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.

What RoleLantern checked

This role is listed from an approved source. RoleLantern checks that the application link is live and how recently the role appeared — the employer has not confirmed it directly on RoleLantern.

RoleLantern checked active

RoleLantern checkedNeeds clarity

Date postedToday

Last source checkToday

Salary listedNeeds clarity

Location clearClear

Something look off? Let us know and we may ask the employer to verify it.

See how you match this role

Upload your CV to see which of this role's requirements your background supports, where there may be gaps, and what needs clarification. Private by default — we never sell your CV.

See my match