Biotechnology Jobs

• USA - Pennsylvania - Upper Providence
• Hybrid · 2 days in office
• US$266,250 – US$443,750 pa
• Director · manages people

Strategically leads global development of an oncology medicine from clinical Proof of Concept to approval in first major markets, acting as single point of accountability. Builds and leads a matrixed Medicine Development Team spanning clinical, medical, commercial and manufacturing, driving evidence packages, governance decisions and lifecycle plans.

• Waltham, United States
• Hybrid · 2–3 days in office
• Director · manages people

Leads end-to-end clinical development of hematology oncology assets from first-in-human studies through registrational trials, regulatory approval and launch. Sets disease-area strategy, chairs governance forums and scientific advisory boards, and line-manages clinical development leads and medical directors within a global matrix team.

AI/ML

• Maidenhead
• Hybrid
• Senior

Leads clinical data management for one or more oncology studies within a sponsor-dedicated (FSP) model, acting as the primary client contact from study set-up through close-out. Combines strategic oversight of vendors, budgets and CDM deliverables with hands-on work such as eCRF design and data cleaning, collaborating with data coordinators and statistical programmers.

eCRF

• Cambridge, United States
• Hybrid · 3 days in office
• Director

Lead end-to-end clinical trial material planning, vendor management, packaging, labeling, inventory and global distribution for an AI-first drug discovery company. Act as the clinical supply authority within a lean Pharmaceutical Sciences & CMC team, building scalable systems and vendor networks while partnering closely with Clinical Operations and CROs.

IRT · RTSM

• 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

• Cambridge
• Senior
• Temporary

Hands-on upstream process development role delivering mammalian cell culture studies, including CHO-based fed-batch and perfusion processes, media and feed optimization, and bioreactor operation from ambr systems to bench-scale stirred tanks. Works under minimal supervision within a matrix CMC team, applying DoE and statistical analysis, supporting scale-up and tech transfer to GMP and CMO partners, and providing day-to-day technical coordination to technicians and operators.

ambr · ambr250 · Stirred-Tank Bioreactors +6

• Newcastle upon Tyne
• Hybrid
• Director

Provides medical and clinical leadership for the development of novel diagnostic and companion diagnostic assays and platforms supporting precision medicine. Acts as subject matter expert for R&D projects, clinical studies and regulatory submissions, and supports pharma partnerships and pathology education. Hybrid role based in Newcastle Upon Tyne with 30-40% international travel.

IVD · CDx · Digital Pathology

• Reading
• Remote
• Lead

Lead end-to-end clinical data management for complex global trials, from study setup through database lock, acting as the primary client contact for data deliverables. Oversee SAE, PK and external data reconciliation, manage timelines and budgets, mentor junior staff, and drive process improvements using Medidata Rave or Oracle InForm.

Medidata Rave · Oracle InForm · EDC +1

• Reading
• Remote
• Lead
• Contract

Oversees end-to-end clinical data management for complex global trials, from study setup through database lock, acting as the primary client contact for data deliverables. Leads cross-functional teams, manages SAE/PK and external data reconciliation, timelines and budgets, and mentors junior staff. Fully remote with equipment provided, working across FSP delivery models.

Medidata Rave · Oracle InForm · MS Teams

• Maidenhead
• Hybrid
• Senior · manages people
• Permanent

Technical lead for all data management activities on late phase (IIb-III) clinical trials, from start-up through completion. Develops Data Management and Quality Management Plans, designs CRF/eCRF and database structures, and coordinates edit checks and discrepancy management. Acts as client liaison, tracking cycle times and metrics while overseeing data review staff.

RAVE · EDC

• London
• Remote
• Mid-level

Oversees medical coding activities across clinical studies, managing coding dictionaries such as MedDRA and WHODrug, reviewing coded data for accuracy and compliance, and preparing coding reports for medical review. Acts as subject matter expert, delivering training and partnering with Clinical Development, Pharmacovigilance and Data Management teams to drive process improvements and regulatory compliance.

MedDRA · WHODrug

• London
• Hybrid
• Senior

Leads global clinical data transparency and disclosure across registries and regulatory platforms such as CTIS, EMA Policy 0070 and Health Canada PRCI, acting as subject matter expert for assigned therapeutic areas. Manages vendor partnerships, FOI access requests, redaction and lay summary work, plus SOP governance, compliance reporting and audit readiness within Global Regulatory Affairs Excellence.

CTIS · ClinicalTrials.gov · EU Clinical Trial Register +3

• London
• Hybrid
• £56,511 – £104,949 pa
• Mid-level

Lead the development and maintenance of global labelling documents for neuroscience medicines, translating clinical and safety data into compliant product information. Facilitate cross-functional discussions, support Health Authority responses, and ensure timely implementation of labelling changes across global and major markets.

• United Kingdom
• Remote
• Senior · manages people

Accountable for delivering clean clinical data on time and within contract for low-to-moderate complexity haematology/oncology trials, managing operational and quality aspects in line with ICH GCP. Develops monitoring plans, CRF documents and Trial Master File content, tracks timelines and metrics, and may handle start-up, ethics submissions and project financials. Works within a team of CTMs, with travel to sites and a focus on radiopharmaceuticals, cell & gene therapy and CAR-T studies.

Outlook · Excel · Word

• Maidenhead
• Senior

Acts as case management subject matter expert for assigned clinical trials, overseeing safety reporting plans, vendor performance and ICSR compliance. Leads pharmacovigilance processes, supports GxP inspections and audits, and provides study-specific training to vendors and internal teams. Requires deep PV and regulatory knowledge in a multinational pharmaceutical setting.

Drug Safety Database