Head of Regulatory Bioanalysis

AstraZeneca • Gaithersburg, MD

6d • $216,996 - $325,494 • Hybrid

About The Position

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.

Requirements

• PhD. or MSc. With at least 10 years’ experience in a regulatory bioanalytical leadership 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.

Nice To Haves

• 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 limited to ligand binding assays mass spectrometry, flow cytometry and techniques to determine immune response.

Responsibilities

• Lead a team of advanced scientists providing technical and scientific solutions to complex bioanalytical challenges across a wide array of modalities.
• Act as test facility manager ensuring compliance with regulatory guidance, SOPs and quality standards.
• Use scientific knowledge and expertise to drive the strategic direction of the regulatory bioanalysis group leveraging advanced AI tools.
• 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.
• Provide scientific direction and technical input while ensuring on time portfolio delivery.
• Work with staff to maximize their potential and achieve career goals.
• Drive innovative solutions to complex portfolio needs through innovative bioanalytical solutions.
• Actively contribute to driving advancement of Integrated Bioanalysis via impact in leadership teams, partnering with peers and stakeholders.
• Partner with leaders across CPSS and the wider AstraZeneca community to advance portfolio assets.
• Ensure data is delivered on time to the required quality standards.
• Act as test facility manager, with expertise in driving, executing and leadership in ensuring compliance with scientific standards and regulatory quality systems.
• Develop, validate and utilize assays to support biomarker analysis needs, with a clear understanding of context of use and deployment.

Benefits

• 401(k) plan
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage
• short-term incentive bonus opportunity
• equity-based long-term incentive program (salaried roles)
• retirement contribution (hourly roles)
• commission payment eligibility (sales roles)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior