10 дней назад
Senior Clinical Trial Lead (Clinical Pharmacology)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Clinical Trial Lead (Clinical Pharmacology): Leading complex Phase I Healthy Volunteer trials from study design and protocol development through reporting, with an accent on dose-escalation strategy, participant safety, and PK/PD interpretation. Focus on coordinating interdisciplinary teams, managing clinical units and vendors, steering risk-based decisions, and maintaining GCP-compliant delivery against quality, timeline, and financial objectives.
Location: Frankfurt, Hesse, Germany
Company
provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.
What you will do
- Lead complex Phase I Healthy Volunteer trials end to end, from preparation and set-up through conduct, close-out, and reporting.
- Drive study design, protocol development, dose-escalation strategy, and interpretation of safety and PK/PD data.
- Coordinate clinical pharmacology, medical, statistics, pharmacokinetics, biosampling, data management, operations, procurement, vendors, and governance stakeholders.
- Manage clinical-unit delivery, recruitment and cohort planning, vendor oversight, study schedules, supplies, and outsourced services.
- Monitor risks, safety, quality, data flows, milestones, financial control, and corrective actions throughout the trial lifecycle.
- Maintain GCP, ICH, regulatory, sponsor-procedure, and inspection-readiness requirements, including essential documentation and reporting.
Requirements
- Recent hands-on leadership of Phase I Healthy Volunteer trials with demonstrated end-to-end accountability.
- In-depth knowledge of early-phase study designs, protocol writing, clinical pharmacology, dose escalation, safety evaluation, and PK/PD concepts.
- Experience with study types such as first-in-human, SAD/MAD, PK/PD, BA/BE, DDI, and food-effect studies.
- Ability to lead interdisciplinary teams, influence without hierarchy, manage conflict, and coordinate sponsor, CRO, clinical-unit, and vendor interfaces.
- Strong knowledge of GCP, ICH guidelines, applicable clinical-trial regulations, SOPs, and global and local requirements.
- Master’s degree or higher in life sciences, medicine, pharmacy, pharmacology, or a related discipline preferred; fluent English required.
Nice to have
- Experience with clinical-unit delivery, cohort scheduling, sentinel or staggered dosing, intensive safety surveillance, and time-critical sample or data flows.
- Therapeutic-area experience in oncology, inflammatory, cardiovascular, renal, or metabolic indications.
- Experience with inspection readiness, vendor oversight, financial management, RFI/RFP activity, or bid defense.
- Medical degree or PhD in life or natural sciences and/or pharmacology.
Culture & Benefits
- Sponsor-dedicated work within integrated clinical development teams.
- Support from experienced specialists, technology, data-driven insights, and study oversight tools.
- Focus on participant safety, scientific quality, transparent governance, and disciplined operational delivery.
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