Biotechnology Jobs

• Rockville, United States
• Hybrid · 2–3 days in office
• £221,925 – £369,875 pa
• Director · manages people

Leads a global oncology labelling team, managing the labelling process from early development through lifecycle management and ensuring regulatory compliance. Serves on the Global Labelling Committee, advises senior R&D, Safety, Regulatory and Commercial leaders, and engages with regulatory authorities on labelling standards and policy.

• Stevenage
• Hybrid
• Director

Individual-contributor alliance lead owning the relationship with an established central laboratory partner, balancing strategic direction with day-to-day governance and delivery oversight. Embeds a new operating model, monitors KPIs and study delivery, resolves escalations, and uses AI tools such as Claude to analyse large datasets and drive continuous improvement.

Claude

• London
• US$188,100 – US$313,500 pa
• Director

Leads end-to-end Model-Informed Drug Development and clinical pharmacology strategy across the drug development lifecycle, from first-in-human studies through filing and lifecycle management. Sits in the Clinical Pharmacology and Quantitative Medicine organisation, partnering with digital medicine, translational imaging, modelling and data science teams, and drafting regulatory content for FDA, EMA and ICH submissions.

MIDD · QSP · AI/ML

• Stevenage
• US$188,100 – US$313,500 pa
• Director

Lead end-to-end application of Model-Informed Drug Development across the drug development lifecycle, from first-in-human studies through filing and lifecycle management, providing clinical pharmacology strategy and evidence generation. Draft and review regulatory content for FDA, EMA, CDE, PMDA and ICH, and build cross-functional partnerships across digital medicine, translational imaging, AI/ML and biostatistics. The role sits in the newly established Clinical Pharmacology and Quantitative Medicine organisation, reporting into the Respiratory, Immunology & Inflammation Research Unit.

MIDD · QSP · AI/ML

• Durham, United States
• US$188,100 – US$313,500 pa
• Director

Leads end-to-end application of Model-Informed Drug Development and clinical pharmacology strategy across the drug development lifecycle, from first-in-human studies through filing and lifecycle management. Partners with digital medicine, translational imaging, modelling and biostatistics teams, and drafts regulatory content for FDA, EMA, CDE, PMDA and ICH submissions. Based in the newly formed Clinical Pharmacology and Quantitative Medicine organisation, with a strong publication and scientific leadership remit.

MIDD · QSP · AI/ML

• Baar Onyx
• Hybrid
• US$222,750 – US$371,250 pa
• Director

Leads end-to-end Model-Informed Drug Development and clinical pharmacology strategy across the drug development lifecycle, from first-in-human studies through filing and lifecycle management. Coordinates CPMS activities across assets, approves study designs and regulatory documents, and partners with digital medicine, translational imaging and modelling specialists. Reports into the Respiratory, Immunology & Inflammation Research Unit within the new CPQM organisation.

MIDD · QSP · AI/ML

• USA - Pennsylvania - Upper Providence
• Hybrid
• US$222,750 – US$371,250 pa
• Director

Leads end-to-end Model-Informed Drug Development and clinical pharmacology strategy across the drug development lifecycle, from first-in-human studies through filing and lifecycle management. Coordinates CPMS activities across assets, approves study designs and regulatory documents, and partners with digital medicine, translational imaging, biostatistics and AI/ML teams. Sits in the newly formed Clinical Pharmacology and Quantitative Medicine organisation, reporting into the Respiratory, Immunology & Inflammation Research Unit.

AI/ML · Digital Medicine · Translational Imaging +2

• Baar Onyx
• US$188,100 – US$313,500 pa
• Director

Leads end-to-end Model-Informed Drug Development and clinical pharmacology strategy across the drug development lifecycle, from first-in-human studies through filing and lifecycle management. Sits in the Clinical Pharmacology and Quantitative Medicine organisation, partnering with digital medicine, translational imaging, modelling and biostatistics teams, and drafting regulatory content for FDA, EMA and ICH submissions.

MIDD · QSP · AI/ML

• USA - Pennsylvania - Upper Providence
• US$188,100 – US$313,500 pa
• Director

Leads end-to-end Model-Informed Drug Development and clinical pharmacology strategy across the drug development lifecycle, from first-in-human studies through filing and lifecycle management. Designs MIDD and ClinPharm evidence strategies, drafts regulatory content for FDA, EMA, CDE, PMDA and ICH, and partners with digital medicine, translational imaging, modelling and data science teams. Sits in the newly formed Clinical Pharmacology and Quantitative Medicine organisation.

MIDD · QSP · AI/ML

• London
• Hybrid
• Lead

Lead programming activities for one or more clinical studies, developing, maintaining and validating complex analysis packages to CDISC and Good Programming Practice standards. Act as technical mentor to junior programmers and lead programming support for regulatory interactions with the EMA and FDA. Works in an agile, squad-based team bridging scientific requirements with technical solutions, with R proficiency preferred.

R

• Stevenage
• Hybrid
• Lead

Leads statistical programming for complex and pivotal clinical studies, developing, maintaining and validating analysis packages while ensuring compliance with Good Programming Practices and CDISC standards. Acts as a technical mentor to junior programmers and leads programming support for regulatory interactions with bodies such as the EMA and FDA, working in an agile, squad-based team alongside clinical, statistical and operational stakeholders.

R

• USA - Pennsylvania - Upper Providence
• Hybrid
• Lead

Lead programming activities for complex and pivotal clinical studies, developing, maintaining and validating analysis packages while ensuring compliance with Good Programming Practices and CDISC standards. Mentor junior programmers, support regulatory interactions with EMA and FDA, and bridge scientific requirements with technical solutions in an agile, squad-based global team.

R

• London
• Hybrid · 2–3 days in office
• US$187,275 – US$312,125 pa
• Director

Leads the scientific design and execution of interventional clinical studies within Medical Affairs, providing medical governance, safety data review and scientific oversight of protocols and analysis plans. Collaborates with cross-functional teams, investigators and thought leaders, and presents results for publications and regulatory submissions. Hybrid role with two to three days per week in office.

Digital Tools

• Waltham, United States
• Hybrid · 2–3 days in office
• US$187,275 – US$312,125 pa
• Director

Leads the scientific design and execution of interventional clinical studies within Medical Affairs, providing medical governance, safety data review and scientific oversight of protocols and analysis plans. Collaborates with cross-functional teams, investigators and thought leaders, and presents results for publications and regulatory submissions. Hybrid role with two to three days per week in office.

• USA - Pennsylvania - Upper Providence
• Hybrid · 2–3 days in office
• US$187,275 – US$312,125 pa
• Director

Leads the scientific design and execution of interventional clinical studies within Medical Affairs, providing medical governance, safety oversight and scientific interpretation of protocols and analysis plans. Collaborates with cross-functional teams, investigators and regulators, and presents results for publications and submissions. Hybrid role with two to three days per week in office.