Director, Oncology Bioanalytical Strategy Lead

AstraZeneca • Cambridge, MA

6d • $175,498 - $263,248 • Onsite

About The Position

As part of the Integrated Bioanalysis (IBA) Global Team, you will be responsible for leading the design and implementation of robust bioanalytical strategies, including, but not limited to, endpoints such as pharmacokinetics (PK), immunogenicity, and biomarkers to support the AstraZeneca pipeline. You will be closely involved in supporting selected oncology portfolio programs by engaging with key stakeholder functions on project teams and subteams, developing holistic bioanalytical strategies, and working closely with internal and external laboratory and CRO teams to ensure the development and validation of assays aligned with their intended context of use. You will serve as the IBA project lead for selected programs, ensuring the development of sound bioanalytical assay designs and their implementation. This will involve close collaboration with IBA scientific and technical laboratory staff, as well as cross-functional stakeholders. The ideal candidate will have a strong track record in regulated bioanalysis supporting therapeutic modalities in oncology and immuno-oncology. Experience supporting antibody-drug conjugates, radioconjugates, or T-cell engagers (TCEs), in addition to traditional biologics, and a background in immunology and immunogenicity are highly desirable. In this dynamic, matrixed environment, you will be responsible for managing stakeholder expectations, contributing to project strategy and delivery, and serving as the primary interface with highly skilled bioanalytical scientists within IBA and our partner laboratories. You will have the opportunity to make an immediate and lasting impact on our diverse pipeline.
The IBA group within Clinical Pharmacology and Safety Sciences provides broad discovery, preclinical, and clinical support including life cycle management across all therapeutic areas enabling pipeline delivery, decision making, innovation and advancement to improve the lives of patients through life-changing medicines.
What you will do
You will be located at one of our U.S. research hubs in Gaithersburg, Maryland, or Boston, Massachusetts, where you will work alongside TA leads and stakeholders in CPSS, Translational Medicine, Research, and Clinical Development. In this role, you will interact closely with bioanalytical leads, CROs, study management, the IBA leadership team, CPSS functional representatives, and other key stakeholder functions to ensure high-quality and timely bioanalytical support for projects. This is a highly visible role, and you will be expected to leverage your scientific knowledge and expertise, organizational capabilities, and operational skills while working with a range of stakeholders and cross-functional groups to gain alignment on strategies and deliverables. You will apply your experience and proven track record in designing, developing, and delivering robust bioanalytical strategies, with a specific focus on scientific oversight and delivery for our Oncology portfolio. You will also work with regulatory agencies and health authorities across multiple countries and geographies to mitigate risk, submit regulatory documents, and respond to health authority questions. As a subject matter expert, you will be responsible for enhancing IBA’s reputation for scientific excellence by presenting at internal and external meetings and publishing manuscripts. As a senior member of the IBA Global Oncology Strategy team, you will be expected to contribute to strategic initiatives aimed at the continued evolution and establishment of the department as a scientific leader and strategic partner.
The successful candidate will work closely with AstraZeneca’s global teams, serve as the IBA project team leader for selected projects, and partner with other IBA members and leaders and external vendor partners to ensure appropriate bioanalytical and platform strategies, scientific oversight, and delivery across multiple modalities, including antibody-drug conjugates (ADCs), radioconjugates (RCs), biologics, cell therapies, and small-molecule products. The successful candidate will also foster an environment of scientific knowledge exchange and collaborate with stakeholders and cross-functional project teams.

Requirements

• Bachelor's degree in immunology, molecular biology, or related studies with minimum of 10+ years relevant experience; OR Master's in immunology, molecular biology, or related studies with minimum of 7+ years relevant experience in Biopharmaceutical industry.
• Experienced in serving as a project representative.
• Worked with stakeholders.
• Experienced in drug development process and regulatory filings.
• Proven experience as a Subject matter Expert in regulated bioanalysis across a range of modalities PK (CK), PD and immunogenicity assessments (humoral and cellular).
• Experienced in regulated bioanalysis, in-depth knowledge of complex biologics and/or bioanalysis of ADCs and related modalities.
• Experienced as a bioanalytical lead in diverse project teams, defining, leading, and implementing robust bioanalytical strategy to advance the portfolio.
• Collaborated with stakeholders, providing solutions to challenges and mitigating risk.
• 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.
• Experienced in assay transfer, scientific quality, and study conduct at CRO partners, data analysis and interpretation, delivery of preclinical and clinical data to project teams.
• Deep understanding of global regulatory expectations and guidance in relevant areas.
• Contributed to regulatory submission documentation such as INDs, CTAs, IBs, ISI and/or NDAs/BLAs and experience in regulatory authority responses across multiple geographies.
• Interpretation of integrated and complicated datasets.
• Ability to handle multiple projects and / or tasks concurrently in a fast-paced environment, ability to prioritize and manage resources.
• Both Line and Matrix management experience, ability to coach and mentor senior bioanalytical leads.
• Background in pharmaceutical clinical trial research.
• Proven publication and presentation record.
• Exceptional verbal and written communication skills.

Nice To Haves

• Experience supporting antibody-drug conjugates, radioconjugates, or T-cell engagers (TCEs), in addition to traditional biologics.
• Background in immunology and immunogenicity.
• Radio conjugates, Cell therapy and or small molecule experience is desired.
• Strong scientific background in immunology, ability to support drug programs across multiple therapeutic areas, deeper expertise in flow cytometry.
• Experienced in partnering with operational functions within bioanalysis, clinical operations, external CROs to develop efficient processes for bioanalytical execution.

Responsibilities

• Leading the design and implementation of robust bioanalytical strategies, including endpoints such as pharmacokinetics (PK), immunogenicity, and biomarkers to support the AstraZeneca pipeline.
• Supporting selected oncology portfolio programs by engaging with key stakeholder functions on project teams and subteams.
• Developing holistic bioanalytical strategies.
• Working closely with internal and external laboratory and CRO teams to ensure the development and validation of assays aligned with their intended context of use.
• Serving as the IBA project lead for selected programs, ensuring the development of sound bioanalytical assay designs and their implementation.
• Collaborating closely with IBA scientific and technical laboratory staff, as well as cross-functional stakeholders.
• Managing stakeholder expectations.
• Contributing to project strategy and delivery.
• Serving as the primary interface with highly skilled bioanalytical scientists within IBA and partner laboratories.
• Interacting closely with bioanalytical leads, CROs, study management, the IBA leadership team, CPSS functional representatives, and other key stakeholder functions to ensure high-quality and timely bioanalytical support for projects.
• Leveraging scientific knowledge and expertise, organizational capabilities, and operational skills while working with a range of stakeholders and cross-functional groups to gain alignment on strategies and deliverables.
• Applying experience and proven track record in designing, developing, and delivering robust bioanalytical strategies, with a specific focus on scientific oversight and delivery for the Oncology portfolio.
• Working with regulatory agencies and health authorities across multiple countries and geographies to mitigate risk, submit regulatory documents, and respond to health authority questions.
• Enhancing IBA’s reputation for scientific excellence by presenting at internal and external meetings and publishing manuscripts.
• Contributing to strategic initiatives aimed at the continued evolution and establishment of the department as a scientific leader and strategic partner.
• Partnering with other IBA members and leaders and external vendor partners to ensure appropriate bioanalytical and platform strategies, scientific oversight, and delivery across multiple modalities, including antibody-drug conjugates (ADCs), radioconjugates (RCs), biologics, cell therapies, and small-molecule products.
• Fostering an environment of scientific knowledge exchange.
• Collaborating with stakeholders and cross-functional project teams.

Benefits

• short-term incentive bonus opportunity
• equity-based long-term incentive program
• retirement contribution
• commission payment eligibility
• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Director