Director Integrated Bioanalysis – Vendor Scientific Strategy Leader
Location: Cambridgeshire, Gaithersburg, Maryland
Job Type: Full time
Bold Disruptors. Push the boundaries of science. Fearlessly break new ground.
Are you ready to work at the cutting-edge, where scientific innovations and an entrepreneurial spirit are the norm? We’re looking for dynamic thought leaders with curious minds, who are comfortable taking smart risks and constantly challenging the boundaries of science all the while learning and developing core skills and experiences.
What we do
We are a global, science-led BioPharmaceutical business and our innovative medicines are used by millions of patients worldwide.
Why we love it
The future is bright at AstraZeneca as we bring ground breaking therapies to complex disease to patients with critical needs. Scientific innovations are at the core of what we do across our industry leading portfolio which drive exciting opportunities and varied work. We’re on an exciting journey to pioneer the future of healthcare!
The role - Director Integrated Bioanalysis – Vendor Scientific Strategy Leader
As part of the Integrated Bioanalysis (iBA) Global Team, you will report to the head of iBA and will be responsible for leading the strategic interface with scientific bioanalytical vendors where you will be responsible for driving a world class collaborative partnership with partners where scientific, regulatory and operational excellence is paramount. You will be an individual contributor working across therapeutic areas and a range of modalities to ensure effective partnership with selected vendors supporting our bioanalytivla needs. You will also be responsible for driving the scientific strategic interface with our CRO partner. Key attribute of the role include being able to work in a matrix environment where you will be expected to understand regulatory as well as scientific requirement to drive novel ways of working that exemplify operational excellence with internal and external partners across IBA, CPSS and partner labs. The ideal leader will design and implement ways of operating to ensure effective collaboration and delivery of robust bioanalytical strategies, including but not limited to, endpoints such as PK/CK, immunogenicity and biomarkers when required to support the AstraZeneca pipeline.
The role requires an individual with a strong leadership track record in impacting at a strategic and commercial level. Working with a dynamic team you will be responsible providing solution to complex challenges while also building partnerships to address future needs. 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’ll do
You will be located at one of our facilities in Europe or US, where you will work alongside colleagues across Integrated Bioanalysis. You will be highly visible and able to use scientific knowledge and expertise while working with a range of stakeholder and cross functional groups. You will be responsible for all aspects of the vendor strategic relationship to ensuring successful partnership at a scientific, technical, operational an strategic level. You will also work with colleagues and strategic partners to ensure smooth transition of projects through key stages of development from candidate selection through approval and line extensions in a range of geographies. You will also be asked to contribute as a Subject Matter Expert and drive innovated learning in a fast-growing aspect of our portfolio while enhancing the iBA reputation for scientific excellence by presenting at internal and external meetings, and publishing manuscripts.
- PhD in Biochemistry, immunology, molecular biology, bioengineering or related studies with significant relevant experience
Essential for the role:
- Drive all aspect of effective partnering and vendor interactions at a strategic level
- Work with partners internally and externally to ensure vendors have ethe ability to deliver scientific, technical and operational needs of AZ portfolio
- Collaborate with stakeholders across the business including but not limited to Business Operations, Quality Assurance, Clinical Operations and Biosampling colleagues
- Proven ability to build effective partnerships across all therapeutic areas and key stakeholders within and outside AZ
- Robust understanding of Pharmaceutics development process and the importance of CRO interfaces
- Ability to manage change in a fast past environment where bringing effective therapies to patients is our number one priority
- Establish and drive strategies on how iBA will ensure delivery of scientific and operational excellence across all modalities
- Proven track record driving innovation partnership and scientific, operational and business processes
- Experienced leader with a proven track record of working with dynamic teams and supporting talent development
- Worked collaboratively with stakeholders, providing solutions to challenges and mitigating risk
- Experience across a range of bioanalytical applications and technical formats including but not limited to, Flow Cytometry, Mass Spectrometry, ELISpot, viral assays, molecular assays (ddPCR, qPCR, RT-qPCR, NGS) cytokine assays, ligand binding assays etc.
- Well-developed understanding of trends in the industry and deep knowledge of global regulatory expectations and guidance
- Collaborate with colleagues to ensure data and scientific insight are available for regulatory submission documentation such as INDs, CTAs, IBs, ISI and/or NDAs/BLAs
- Ability to interpret and integrated complex datasets to draw conclusions that drive vendor relationship strategy
- Ability to handle multiple projects and / or tasks concurrently in a fast-paced environment
- Ability to develop, coach and mentor
- Background in pharmaceutical development
- Exceptional verbal and written communication skills
Desirable for the role:
- Proven experience as a Subject Matter Expert in pre-clinical and clinical bioanalysis capable of designing and driving bioanalytical strategies for PK/CK, PD biomarkers and immunogenicity assessments (humoral and cellular)
- Matrix or line management experience
- Experienced in discovery bioanalysis for other drug modalities
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics (e.g. race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status). We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.