Descripción de la oferta
Clinical Development Manager
Role Overview
This role provides operational and scientific support to the Clinical Development team in the planning, execution, analysis, and oversight of preclinical and clinical studies. The position focuses on studies involving pharmacokinetics, toxicology (including toxicokinetics), and analytical validation, ensuring compliance with regulatory requirements, GLP/GCP principles, and internal quality standards.
Key Responsibilities
Study Planning & Design
- Lead the design of preclinical studies and contribute to clinical study design in line with current regulatory requirements for pharmaceuticals and biologics
- Support the preparation and review of study protocols, analytical plans, and technical documentation
CRO Management & GLP/GCP Oversight
- Identify, evaluate, and manage external Contract Research Organizations (CROs), ensuring scientific quality, regulatory compliance, adherence to timelines, and budget control
- Oversee study execution at CROs, ensuring protocol compliance and adherence to GLP/GCP standards
- Manage deviations, amendments, and study-related issues
- Support or conduct small-scale internal studies when required
Scientific & Analytical Support
- Review and assess analytical methods and bioanalytical data supporting pharmacokinetic, toxicokinetic, and pharmacology studies
- Calculate and interpret pharmacokinetic parameters
- Contribute to the scientific evaluation of study outcomes
- Ensure the integrity and consistency of study reports and raw data
Documentation & Regulatory Support
- Maintain accurate, complete, and well-organized study documentation (protocols, contracts, reports, raw data, and correspondence) in line with internal procedures
- Support regulatory activities by preparing or reviewing technical sections of dossiers (e.g., safety, efficacy, pharmacokinetics)
- Contribute to expert reports and regulatory submissions
- Prepare or review scientific materials, summaries, and publications to support product development and lifecycle management
Compliance & Continuous Improvement
- Stay up to date with relevant regulations, guidelines, and scientific developments
- Contribute to process improvements and provide scientific input to cross-functional teams
- Support additional activities as required by the Clinical Development team
Location
- Remote within Europe, the UK, or the US
- Primarily hybrid (home/office-based), with occasional travel for CRO visits, audits, and study-related activities
Candidate Profile
Education
- Degree in Veterinary Medicine, Pharmacy, or a related life science discipline
- Postgraduate training in pharmacology, toxicology, or a related field is highly desirable
- Strong understanding of bioanalysis and pharmacokinetics
Experience
- Experience within research institutions, universities, CROs, or preferably the pharmaceutical/animal health industry
- Prior involvement in preclinical studies, GLP environments, or pharmacokinetic/toxicology projects is preferred
Skills & Competencies
- Strong analytical and scientific reasoning skills
- Familiarity with statistical principles, data processing workflows, Excel, and pharmacokinetic modelling tools
- Excellent communication and interpersonal skills with a collaborative, proactive approach
- Ability to manage multiple projects simultaneously while maintaining high-quality documentation
- Strong organizational skills and attention to detail
Languages
- Fluency in English (spoken and written) is essential
- Additional European languages are considered an advantage
