Associate Director/Director, Oncology Bioanalytical Lead, Integrated Bioanalysis

Associate Director/Director, Oncology Bioanalytical Lead, Integrated Bioanalysis

The role

As part of the Integrated Bioanalysis (IBA) Global Team, you will be responsible for the development and implementation of robust bioanalytical strategies, including but not limited to, endpoints such as PK/CK, immunogenicity and biomarkers when required to support the AstraZeneca pipeline.  You will be intimately involved in ensuring lab-based activities are aligned with context of use.  You will work in a matrix environment to manage aspects such as experimental design and tech transfer and will need to foster s close interaction with other scientific and technical staff in the lab.  The ideal candidate will have a strong track record in regulated bioanalysis supporting therapeutic modalities across Oncology and or other therapeutic areas.  Working with a dynamic team in a matrixed environment you will need to influence and manage stakeholder expectations, provide input to project strategy and delivery while being the main interface with experienced and highly skilled bioanalytical scientist colleagues 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 ideally on the east coast of the US, (Gaithersburg, MD or Boston, MA), where you will work alongside TA leads, Translational Medicine and Bioanalytical Scientists and Operations groups.  In this role you will interact closely with scientists in and outside the lab based and you will be required to aid in experimental design and data interpretation of key experiments.  This is a highly visible role, and you will be required to leverage your scientific knowledge and expertise while working with a range of stakeholder and cross functional groups.  You will need to use your experience and proven history in designing, developing and delivering robust bioanalytical strategies with a specific focus on scientific oversight and delivery for our Oncology portfolio. You will interface with clinical study teams, clinical pharmacology and Translational colleagues and support clinical studies by delivering PK, Immunogenicity, and biomarker data. You will lead internal iBA teams and manage external CROs and enable support of preclinical and clinical studies. You will also have opportunities to interface 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.   Associate Director level will collaborate closely with senior bioanalytical leaders in the organization and provide support in drafting such regulatory responses.  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.

The successful candidate will work closely with AstraZeneca laboratory groups within IBA and our vendor partners to ensure appropriate bioanalytical and platform strategies, scientific oversight and delivery on our pipeline while fostering an environment of scientific knowledge exchange. They will also interact with stakeholders and cross functional project teams.

Level of the position will be commensurate with experience and qualifications.

Education/Experience required:

• PhD in immunology, molecular biology, or related studies with minimum of 3+ years relevant experience in Biopharmaceutical industry. 
   

Essential for the role:

• 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 as a bioanalytical lead in diverse project teams, defining, leading and implementing robust bioanalytical strategy to advance the portfolio.

• Demonstrated experience in bioanalytical assay development and validation.

• Worked collaboratively with stakeholders, providing solutions to challenges and mitigating risk.

• Skilled scientist able to discern the advantages of a range of analytical techniques such as molecular assays (ddPCR, qPCR, RT-qPCR), flow cytometry, ELISpot, viral assays, cytokine assays, ligand binding assays and Mass Spectrometry

• In depth knowledge of concepts such of context of use of fit