Head of Regulatory Bioanalysis

AstraZeneca GmbH; Gaithersburg (MD); Hybrid; USD 217,000 - 325,000; Full time

Job summary

AstraZeneca Gaithersburg is seeking a Head of Regulatory Bioanalysis to lead a strategic team across pharmacokinetics, biomarkers and immunogenicity programs.

You will mentor senior scientists, collaborate with CPSS and Health Authorities worldwide, drive high‑quality data delivery and regulatory submissions, and explore AI-enabled solutions to accelerate portfolio decisions.

Qualifications

• PhD or MSc with 10+ years in regulatory bioanalytical leadership.
• Proven ability to lead a team of advanced scientists delivering on-time portfolio delivery.
• Experience mentoring and coaching to develop talent.

Responsibilities

• Lead regulatory bioanalysis strategy across PK, biomarker and immunogenicity programs.
• Drive regulatory submissions and interactions with Health Authorities.
• Develop and mentor senior scientists to strengthen capabilities.

Skills

Regulatory leadership

Talent development

Strategic bioanalysis

Stakeholder collaboration

Education

PhD or MSc

Tools

AI tools

Bioanalytical methods

Job description

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 experience in implementing automated AI solutions
• Internationally recognised bioanalytical thought leader
• Line 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 response

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.

The annual base pay (or hourly rate of compensation) for this position ranges from $216,996 - 325,494. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours.Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles),to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Date Posted

01-Sept-2026

Closing Date

14-Sept-2026

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.