Head of Regulatory Bioanalysis

About this role

Title: Head of Regulatory B ioanalysis 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 w ork at the cutting-edge , where scientific innovations and an entrepreneurial spirit are the norm ?   W e’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 interpretatio n to drive key decisions thought the use of the hi ghe st 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 bioanaly sis 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 provid ing 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 ens ur ing compliance with regulatory guidance, SOPs and quality standards .  In this highly v isible role, you will be required to u se 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 1 0 years’ experience in a re gulatory bioanalytical leadership role.  

Essential for the role:  

• Capable of c ontribut ing directly to AstraZeneca leading position in driving s cience and innovation in the field of bioanalysis  

• Proven ability to l ead a team of advanced scientists providing scientific direction and technical input while ensuring on time portfolio delivery  

• Capab le of working with staff to maximise their potential and achieve career goals  

• Experience in driving in novative solution s 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 sta keholders  

• Ability to p artner 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 a bility to a ct as test facility manager , with expertise in driving, executing and leadership in ensuring compliance w ith scientific standards and regulatory quality systems   

• Clear understanding of context of use and deployment i n 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 experience in implem en ting automated AI solutions  

• Internationally recognised bioanalytical thought leader  

• L ine management experience  

• Experienced in multiple therapeutic modalities    

• Expertise of multiple analytical methods including but not limed to ligand binding assays mass spectrometry, flow cytometry and techniques to determine immune respon se    

So, what’s next?  

Are you already imagining yourself joining us? Good, because we can’t wait to hear from you!  

Additional information  

Our Company Values & Behaviors underpin everything we do so please take a moment to familiarize yourself with them. You may also want to check out our new R&D Video showing how we turn Science into Medicines.   

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application o

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