Biotechnology Jobs

• Haywards Heath
• Hybrid · 3 days in office
• Director · manages people

Leads a global team of development and regulatory project managers overseeing complex R&D programs across a therapeutic area, including new product development and lifecycle management. Acts as strategic partner to TA and R&D leadership, driving portfolio planning, agile delivery, risk removal and cross-functional alignment as part of the Portfolio & Operations Excellence leadership team.

Microsoft Project · Planview · Smartsheet +1

• London
• Director · manages people

Lead global labelling strategy for assigned products across early and late-stage development, lifecycle management and marketed portfolios, serving as Therapeutic Area Lead. Drive core labelling documents including CCDS, USPI and EU PI, lead health authority negotiations, and shape a future USPI operating model while championing digitalisation and AI-enabled labelling solutions.

FDA · EMA · ICH

• Gaithersburg, United States
• On-site
• US$218,330 – US$327,494 pa
• Director

Leads competitive intelligence for AstraZeneca's oncology R&D, owning delivery of clinical and commercial analysis that shapes therapy-area strategy and portfolio investment decisions. Works with a specialist team and senior leadership, translating complex data into insights and challenge. Requires oncology, clinical or investment analysis background.

• Cambridge, United States
• On-site
• US$218,330 – US$327,494 pa
• Director

Leads competitive intelligence for AstraZeneca's oncology pipeline, delivering clinical and commercial analysis that shapes therapy-area strategy and investment decisions. Partners with senior leadership and cross-functional teams, providing respectful challenge and insight into the evolving oncology landscape. Requires oncology, clinical research or investment analysis background with strong communication and influence skills.

• USA - Pennsylvania - Upper Providence
• US$139,425 – US$232,375 pa
• Director

Acts as the operational hub for oncology assets, owning the integrated project plan, budget and risk inputs while driving critical-path acceleration and governance decisions. Partners with project leads to navigate uncertainty, facilitate high-performing teams and embed consistent project management practices across the pipeline.

Planisware · MS Project

• Waltham, United States
• US$139,425 – US$232,375 pa
• Director

Acts as the operational 'COO' of a drug or vaccine asset, owning the single integrated project plan and partnering with project leads to steer strategy through complexity. Drives critical-path acceleration, risk management, governance preparation and cross-functional handoffs, with budget and resource forecasting using tools such as Planisware or MS Project.

Planisware · MS Project

• Uxbridge
• Hybrid
• Director

Serves as scientific authority for clinical studies across an assigned asset or indication, from protocol development through CSR review and regulatory submission. Leads clinical oversight of study data with Data Management and Programming, may act as Trial Lead on complex global studies, and presents to investigators, KOLs and senior leadership. Also supports process improvement, training and mentoring within the Clinical Capabilities function.

• Cambridge
• Director · manages people

Leads a team of medical writers and oversees strategic planning and drafting of complex regulatory submissions at the therapeutic area or portfolio level. Acts as subject matter expert, driving document strategy with cross-functional teams across Regulatory Affairs, Clinical Research and Clinical Data Science, plus process improvement and training initiatives.

Workday

• Maidenhead
• Hybrid · 3 days in office
• Director

Leads strategic sourcing and evaluation of external innovation opportunities in Haematology, identifying preclinical to Phase 1 assets and shaping early partnering strategies. Sits on the Therapeutic Area Leadership Team, co-leads New Product Opportunity reviews, drives cross-functional due diligence and works with Business Development on deal execution. Hybrid, three days a week at an R&D hub site.

• Harrow
• Remote
• Senior

Acts as principal labelling strategist within Global Regulatory Affairs, driving development and maintenance of dCCDS, CCDS, USPI and EU SmPC documents across an assigned product portfolio. Leads Global Labeling Committee reviews of proposed label exceptions and represents labelling on regulatory strategy teams, working with safety, clinical and commercial stakeholders. Home or office based across European locations.

Company Core Data Sheet (CCDS) · Development Company Core Data Sheet (dCCDS) · US Prescribing Information (USPI) +3

• London
• Hybrid
• £67,900 – £126,100 pa
• Director · manages people

Lead statistical programming for complex global clinical programs from phase I to IV, coordinating internal and external programmers and setting programming strategy with biostatisticians. Drives adoption of R packages, Shiny applications and AI-enabled tools for visualization and reproducible workflows, while managing resources and acting as functional mentor within the therapy area community.

R · Tidyverse · R Shiny +1

• London
• Hybrid
• Director · manages people

Leads global operational delivery of early development oncology programs, managing Clinical Project Managers, Monitoring Leads and CTAs. Owns the clinical development plan, CRO and site selection strategy, budgets and timelines, and serves on Asset Teams. Requires deep first-in-human and Phase I oncology trial expertise.

Microsoft Office

• London
• Hybrid
• Director

Leads end-to-end translational strategy for neurodegenerative and neuromuscular programs, bridging preclinical research to Phase 1–2 clinical development. Accountable for biomarker strategy, clinical endpoint selection and early-phase trial design, and serves as the Translational Medicine representative within global cross-functional project and clinical trial teams.

• Uxbridge
• Hybrid
• Director

Leads EU regulatory strategy for an immunology and cardiovascular portfolio, from early development through registration and lifecycle management. Acts as the regulatory lead for assigned development teams, negotiating with the EMA and other health authorities and building integrated submission plans. Integrates scientific, medical, legal and business perspectives while monitoring European regulatory trends.

EMA

• London
• Hybrid
• Director
• Permanent

Safety expert serving as global PV lead for gene therapy products across investigational and marketed phases, owning benefit-risk strategy, aggregate reports (PSURs, DSURs) and risk management plans. Also acts as medical monitor, providing clinical oversight, real-time AE/SAE review and signal detection in close collaboration with cross-functional teams and health authorities.

Veeva