Overview
Amphista Therapeutics is a fast-growing Cambridge-based biotech and the leading European Targeted Protein Degradation (TPD) company. Our unique scientific approach to TPD, one of the hottest areas in modern drug discovery, gives us a range of advantages over other therapeutic strategies.
In addition to an oversubscribed $53M funding round in 2021, we recently announced collaboration deals with Bristol Myers Squibb and Merck Healthcare to grow and advance our therapeutic portfolio even faster. Initially founded from the laboratory of Professor Alessio Ciulli (University of Dundee), our team comprises both academic and drug discovery pioneers in the TPD field and a growing R&D team focused on advancing a portfolio of medicines to the clinic using our proprietary next generation TPD technologies.
When you join Amphista, you become a part of a world-class team dedicated to achieving excellence. Our people are pioneers, collaborators and goal-driven innovators who thrive in ambiguous environments. The diverse backgrounds across our organisation bring solutions to science's most complex challenges. This cultural DNA runs throughout our organisation and we approach each day with energy, optimism, and an aligned goal.
Department: Clinical Operations
Role Summary
The (Senior) Director, Clinical Scientist will provide strategic and scientific leadership in the design, execution, and interpretation of (primarily) early phase oncology clinical trials. Thriving in a collaborative, fast-paced environment the role will utilise their deep expertise in oncology drug development, clinical trial design, and regulatory strategy to support advancement of innovative cancer therapies, ensuring the generation of high-quality clinical data to support regulatory submissions and product approvals.
Responsibilities
* Lead oncology clinical programs, including hematologic malignancies and solid tumors.
* Design and develop, in conjunction with the clinical lead and the study team, oncology-specific clinical trial documents to include protocols, study reports and regulatory documents (e.g., INDs, NDAs, briefing books).
* Continually review and interpret oncology clinical data in partnership with the clinical lead and provide strategic insights to internal and external stakeholders.
* Collaborate with key internal and external partners to ensure alignment on study objectives and deliverables ensuring timely and compliant study execution.
* Represent Clinical Science in cross-functional teams, advisory boards, and regulatory meetings (e.g., FDA, EMA).
* Engage with oncology Key Opinion Leaders (KOLs) and contribute to scientific publications and presentations.
* Ensure compliance with ICH-GCP, regulatory requirements across global regions, and internal SOPs.
* Provide leadership to study team members and mentor junior staff as required.
Qualifications
* Advanced degree (MD, PhD, PharmD, or equivalent) in oncology, hematology, or a related life sciences discipline.
* 10+ years of experience in global clinical development within the pharmaceutical or biotech industry.
* Proven track record in designing and executing oncology clinical trials, particularly early-phase (FIH) programs.
* Strong understanding of global oncology regulatory requirements and clinical trial methodology.
* Excellent communication, leadership, and analytical skills.
* Ability to thrive in a fast-paced, matrixed, and collaborative environment.
* Experience supporting oncology regulatory submissions.
* Familiarity with biomarkers, companion diagnostics, and precision medicine approaches in oncology.
* Global oncology trial experience.
This is a permanent position, based in Cambridge, UK, with a competitive salary and benefits package.
Seniority level
* Director
Employment type
* Full-time
Job function
* Research, Analyst, and Information Technology
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