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.

Education/Experience required:

• PhD in immunology, molecular biology or related studies with at least 2 years industry experience

• MSc in immunology, molecular biology or related studies with at least 5 years industry experience

• BSc. in immunology, molecular biology or related studies with at least 8 years industry experience
  

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 for purpose assay validation in bioanalysis

• Overseen assay transfer, scientific quality and study conduct at CRO partners.

• Deep understanding of global regulatory expectations and guidance

• Contributed to regulatory submission documentation such as INDs, CTAs, IBs, ISI and/or NDAs/BLAs and experience in regulatory authority responses across multiple geographies.

• Data analysis, Interpretation of integrated and complicated datasets

• Ability to handle multiple projects and / or tasks concurrently in a fast-paced environment.

• Ability to influence partners and stakeholders without authority.

• Ability to innovate, learn quickly and be proactive.

• Background in pharmaceutical clinical trial research

• Proven publication and presentation record

• Exceptional verbal and written communication skills

Desirable for the role:

• Matrix or line management experience

• Experienced in regulated bioanalysis for other drug modalities.
  

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn't mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca's Biopharmaceuticals R&D division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference by fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs.

Embrace new and varied opportunities to develop and learn at AstraZeneca. Here, you get to work on things that have never been done before. In return, when great science comes alive, we have the opportunity to get published.

Are you ready to make a difference? Apply now and join us in our mission to improve the lives of patients through life-changing medicines!

Date Posted

13-Dec-2024

Closing Date

20-Dec-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.