Head of Regulatory Bioanalysis

Title: Head of Regulatory Bioanalysis
Location: Gaithersburg, Maryland, US
Hybrid Working: 3 days per week in the office
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
The Integrated Bioanalytical team 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.
We have an opening for a strong strategic and scientific thought leader with extensive experience in regulatory bioanalysis to drive portfolio value. Key attributes of the role include robust scientific and technical depth, demonstrated ability to drive the strategic development of the regulatory bioanalysis team across a range of impact areas including but not limited to Pharmacokinetics, Biomarker and Immunogenicity testing and interpretation to drive key decisions thought the use of the highest quality data delivery in line with portfolio demand.
The ideal candidate will have a proven track record in developing talent though mentoring and coaching experience.
What you’ll do
You will be located at our Gaithersburg strategic hub, where you will work alongside TA leads and stakeholders. You will be expected to contribute directly to AstaZeneca’s leading position driving science and innovation in the field of bioanalysis impacting assets across the portfolio. This is a key leadership role leading a team of advance scientists providing technical and scientific solution to complex bioanalytical challenges across a wide array of modalities. You will be expected to have a proven track record as a bioanalytical thought with an outstanding reputation for providing innovative solution in regulatory bioanalysis while ensuring systems are in place to enable data is delivered to the required quality standard. The successful candidate teak up the role as test facility manager ensuring compliance with regulatory guidance, SOPs and quality standards. In this highly visible role, you will be required to use your scientific knowledge and expertise to drive the strategic direction of the regulatory bioanalysis group leveraging advanced AI tools. You will also work with team members to ensure interfaces with regulatory agencies and Health Authorities across a range of countries and geographies to mitigate risk, submit regulatory documents and responding to Health Authority questions.
Education/Experience required:
PhD. or MSc. With at least 10 years’ experience in a regulatory bioanalytical leadership role.
Essential for the role:
Capable of contributing directly to AstraZeneca leading position in driving science and innovation in the field of bioanalysis
Proven ability to lead a team of advanced scientists providing scientific direction and technical input while ensuring on time portfolio delivery
Capable of working with staff to maximise their potential and achieve career goals
Experience in driving innovative solutions to complex portfolio needs though innovative bioanalytical solutions
Actively contribute to driving advancement of Integrate Bioanalysis via impact in leadership teams, partnering with peers and stakeholders
Ability to partner with leaders across CPSS and the wider AstraZeneca community to advance portfolio assists.
In depth understanding of regulatory submission needs across geographies
Proven track record in assessing and developing talent
Accountable for ensuring data is delivered on time to the required quality standards
Proven ability to act as test facility manager, with expertise in driving, executing and leadership in ensuring compliance with scientific standards and regulatory quality systems
Clear understanding of context of use and deployment in developing, validating and utilizing assay to support biomarker analysis needs
Proven publication and presentation record
Exceptional verbal and written communication skills
Desirable for the role:
Advanced e