Director, Bioanalytical Development
This is what you will do:
The Director of Bioanalytical Development will lead BA activities and develop bioanalytical strategy for the projects they support. This role will create and drive a bioanalytical development plans and collaborate with project teams and governance bodies. Lead and build positive relationships to create an environment to constantly ensure compliance with internal procedures and processes set up by the BA group and with guidance documents from the FDA, EMA and other regulatory agencies. Develop strategies, interact with regulatory agencies for specific issues on bioanalytical methods and is accountable for provision of the bioanalytical portions of IND, NDA/BLA/MAA, IB CSRs and other regulated documents and devising strategies for Regulatory interactions as needed. In addition, the incumbent is also responsible for providing input in the development of bioanalytical protocols, ensuring successful input into the design of assays to support the studies and scientific review and approval of work by CROs and consultants. The incumbent will collaborate with Alexion departments including Regulatory Affairs, Clinical Operations, Biostatistics, Data Management, Project Management, Toxicology, and Discovery Research for the design and execution of bioanalytical components (PK, PD, immunogenicity, complement biomarkers, etc) of studies. The incumbent participates in various teams including Clinical Pharmacology sub-team, study teams and project teams to support therapeutics at various stages of discovery/development.
You will be responsible for:
- Build a bioanalytical strategy and development plan for therapeutics at various stages
- Build an environment of inclusion, compliance, continual improvement and high efficiency
- Lead functions within Bioanalytical development to develop SOPs that guide the day-to-day operations of the regulated bioanalytical laboratory and to ensure that the bioanalytical staff is fully trained on these SOPs and associated regulations (including GLP)/regulatory guidance documents
- Manage compliance of all regulated bioanalytical laboratory operations, to support development activities, with good laboratory practices (GLP), OECD regulations, FDA, EMA, PMDA and other relevant global bioanalytical and immunogenicity guidance documents
- Manage, mentor and lead a bioanalytical (BA) sub-team to support nonclinical and clinical innovations by developing and qualifying/validating bioanalytical assays as appropriate
- Serve as the BA Project Lead for exciting projects in the pipeline requiring input from a highly experience bioanalytical scientist on PK, PD and immunogenicity assays. Own the interpretation of bioanalytical data provided to project teams and Alexion governance bodies.
- Responsible for the preparation of clinical study protocols, reports and the BA sections of IND, IMPD, BLA/MAA, EOP2 meetings and other regulatory documents.
You will need to have:
- Proven track record in bioanalytical development for biologicals
- Lead and managing bioanalytical projects
- GxP regulation proficiency
- Experience in writing documents to be included in regulatory submissions for NDA/BLA and meeting with regulators to discuss the bioanalytical package that is included in the final NDA/BLA submission
- Strong leadership, mentorship and capability skills
- Leadership developing, validating and troubleshooting pharmacokinetics, pharmacodynamics, and immunogenicity assay development and validations
- Experience in preparing bioanalytical components of clinical and non-clinical study protocols, study reports
- Experience in regulatory agency inspection
- Potential travel approximately 10%
- The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees are required, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
We would prefer for you to have:
- Doctoral degree (PhD) in biology, biochemistry or relevant field
- A minimum of 8 years of pharmaceutical industry experience in regulated bio-analysis in non-clinical and clinical studies
- CRO Management
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. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization 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.
Expectation of working in the office 4 days a week statement: When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of four 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.