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Executive Director, Head of Bioanalytical- BioPharma Development
Location:
Gaithersburg, MD
Description:
Do you have expertise in, and passion for science? 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. Locations: Gaithersburg, MD; Waltham, MA; Gothenburg (Sweden); Cambridge (UK) What we do We are a global, science-led Biopharmaceutical business and our innovative medicines are used by millions of patients worldwide. 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. 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! What you'll do As part of the Integrated Bioanalysis (iBA) Global Team, you will report to the global head of iBA. You'll have responsibilities for leading a team of scientists designing and driving execution of complex bioanalytical strategies while making a direct and tangible impact on all aspect of AstraZeneca's Biopharmaceutical portfolio, including therapeutic areas such as Cardiovascular and renal metabolism (CVRM), Vaccines and immunology (V&I), Neuroscience (NSc.)as well as Respiratory and Immunology (R&I).You will also be responsible for driving the scientific strategic interface with our CRO partner. You will drive interactions with key stakeholders across the business including but not limited to Safety Science, Clinical Pharmacology, Business Process Operations, Therapeutic areas, Patient Safety, Quality Assurance and Regulatory Affairs. 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.Working with a dynamic team you will be responsible providing solution to complex challenges while also building a dynamic team of scientist with diverse technical expertise and an innovative mindset.You will have the opportunity to have an immediate and lasting impact to our diverse pipeline.This is a role that requires a high level of collaboration across other strategy leads within Bioanalysis to ensure effective relationship with CROs. Education/Experience required: PhD in Biochemistry, immunology, molecular biology, bioengineering or related studies.10+ years of relevant experience with at least 2 years' experience driving teams to to bring drugs to market Essential for the role: Ability to build effective partnerships across all therapeutic areas and key stakeholders within and outside AZAbility to manage change in a fast past environment where bringing effective therapies to patients is our number one priorityEstablish and drive strategies on how iBA will ensure delivery of scientific and operational excellence across all modalitiesProven track record driving scientific innovationProven ability to develop assets through all stages of drug developmentProven 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)Experienced leader with a proven track record of working with dynamic teams and driving talent developmentExperienced development bioanalysis leader capable of working across diverse fast-moving team, leading and implementing robust bioanalytical strategy to advance the portfolioWorked collaboratively with stakeholders, providing solutions to challenges and mitigating riskExperience 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.Lead a team that act as subject matter experts working with colleagues supporting assay transfer, scientific quality and study conduct at CRO partnersWell-developed understanding of trends in the industry and deep knowledge of global regulatory expectations and guidanceCollaborate with colleagues to ensure data and scientific insight are available for regulatory submission documentation such as INDs, CTAs, IBs, ISI and/or NDAs/BLAsAbility to interpret and integrated complex datasets to draw conclusions that drive key portfolio decisionsAbility to handle multiple projects and / or tasks concurrently in a fast-paced environmentAbility to develop, coach and mentorBackground in pharmaceutical developmentProven publication and presentation recordExceptional verbal and written communication skills Desirable for the role: Matrix or line management experienceExperienced in discovery bioanalysis for other drug modalities So, what's next? Are you already imagining yourself joining us? Good, because we can't wait to hear from you!If you're curious to know more then please reach out to (contact person) We welcome with your application, no later than November 13, 2023. Date Posted 30-Apr-2024 Closing Date 30-May-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.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
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