Director, Oncology Bioanalytical Strategy Lead

AstraZeneca • Waltham, MA

1d • 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 PK, immunogenicity and biomarkers to support the AstraZeneca pipeline. You will be intimately involved in selected oncology portfolio support by engaging with key stake holder functions in project teams/sub-teams, developing holistic bioanalytical strategies, work closely with lab-based internal and external (CRO) teams to ensure development and validation of assays aligned with context of use. You will serve as the IBA project lead on the select programs, ensure development of sound bioanalytical assay designs and implementation by working closely with iBA scientific and technical staff in the lab as well as with cross-functional stake holders. The ideal candidate will have a strong history in regulated bioanalysis supporting therapeutic modalities across Oncology/Immuno-oncology. Experience in supporting Antibody-drug or Radio-Conjugates or TCEs, in addition to traditional biologics and background in immunology/immunogenicity is desired. Collaborating with a dynamic team in a matrixed environment you will need to manage stakeholder expectations, input to project strategy and delivery while being the main interface with the highly skilled bioanalytical scientist colleagues within iBA and/or our partnered labs. You will have the opportunity to have an immediate and lasting impact to 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 research hubs in the US, (Gaithersburg, MD or Boston, MA) 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, leadership team of iBA, CPSS functional representatives, other key stake holder functions to ensure quality and timely bioanalytical support of projects. This is a highly visible role, and you will be required to leverage your scientific knowledge and expertise, organizational and operational skills, while working with a range of stakeholder, and cross functional groups and gain alignment on strategies and deliverables. You will need to use your experience and proven track record 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 a range of 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 the IBA reputation for scientific excellence by presenting at internal and external meetings, and publishing manuscripts. As a senior member in the iBA-global oncology strategy team you will be expected to contribute to strategic initiatives aimed at continued evolution and establishment of the department as a scientific leader/strategic partner. The successful candidate will work closely with AstraZeneca global groups, serve as the leader of IBA project teams (select projects), partner with other members and leaders in IBA, external vendor partners to ensure appropriate bioanalytical and platform strategies, scientific oversight and delivery for multiple modalities including, ADCs, RCs, biologics, cell, small molecule pipeline while fostering an environment of scientific knowledge exchange. They will also interact with stakeholders and cross functional project teams.

Requirements

• Master's in immunology, molecular biology, or related studies with minimum of 10+ years relevant experience; OR PhD 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

• Strong history in regulated bioanalysis supporting therapeutic modalities across Oncology/Immuno-oncology.
• Experience in supporting Antibody-drug or Radio-Conjugates or TCEs, in addition to traditional biologics and background in immunology/immunogenicity is desired.
• 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 but not limited to, endpoints such as PK, immunogenicity and biomarkers to support the AstraZeneca pipeline.
• Intimately involved in selected oncology portfolio support by engaging with key stake holder functions in project teams/sub-teams, developing holistic bioanalytical strategies.
• Working closely with lab-based internal and external (CRO) teams to ensure development and validation of assays aligned with context of use.
• Serving as the IBA project lead on select programs, ensuring development of sound bioanalytical assay designs and implementation by working closely with iBA scientific and technical staff in the lab as well as with cross-functional stake holders.
• Leveraging scientific knowledge and expertise, organizational and operational skills, while working with a range of stakeholder, and cross functional groups and gain alignment on strategies and deliverables.
• Using experience and proven track record designing, developing, and delivering robust bioanalytical strategies with a specific focus on scientific oversight and delivery for our Oncology portfolio.
• Working with regulatory agencies and Health Authorities across a range of countries and geographies to mitigate risk, submit regulatory documents and respond to Health Authority questions.
• Enhancing the IBA reputation for scientific excellence by presenting at internal and external meetings, and publishing manuscripts.
• Contributing to strategic initiatives aimed at continued evolution and establishment of the department as a scientific leader/strategic partner.
• Working closely with AstraZeneca global groups, serving as the leader of IBA project teams (select projects), partnering with other members and leaders in IBA, external vendor partners to ensure appropriate bioanalytical and platform strategies, scientific oversight and delivery for multiple modalities including, ADCs, RCs, biologics, cell, small molecule pipeline while fostering an environment of scientific knowledge exchange.
• Interacting with stakeholders and cross functional project teams.

Benefits

• Qualified retirement program [401(k) plan]
• Paid vacation and holidays
• Paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage
• Short-term incentive bonus opportunity
• Equity-based long-term incentive program (salaried roles)
• Retirement contribution (hourly roles)
• Commission payment eligibility (sales roles)

What This Job Offers

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