Global Study Director

About Amphista

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 were delighted to recently announce two separate collaboration deals with Bristol Myers Squibb and Merck Healthcare which will allow us 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 of 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 sciences 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 Global Study Director will be responsible for the strategic planning, execution, and delivery of (primarily) early phase oncology clinical trials. This individual will use their deep experience in clinical operations and regulatory compliance to lead cross-functional study team/s (to include external vendors) to ensure high-quality, timely, and cost-effective execution of clinical studies.

This position requires:

Minimum BSc in life science with advanced degree (PhD, PharmD, RN, or equivalent) in life sciences or healthcare-related field preferred.

• 10+ years of experience in global clinical research, with at least 5 years in early oncology clinical trial management.
• Proven track record of leading global clinical studies in a pharmaceutical or biotech setting to time, cost and quality.
• Experienced in the selection, set-up, management and oversight of clinical trial vendors and Contract Research Organisations (CROs).
• Strong knowledge of clinical trial methodology, ICH-GCP, regulatory requirements, and operational aspects of clinical development.
• Extensive experience in the financial management of clinical studies.
• Proven experience in delivering a patient centric approach to clinical trial set-up and execution.
• Experience in identifying, leading and contributing the development of SOPs and guidelines related to clinical trial execution.
• Excellent leadership, communication, and organizational skills.
• Ability to work effectively in a matrixed, fast-paced environment.
• Experience with both early-phase and late-phase oncology trials is advantageous.

Profile required:

• Lead the planning and execution of global oncology clinical studies from study start-up through to close-out and archiving.
• Serve as the primary point of contact for study-related activities and communications across internal and external stakeholders.
• Develop and manage study timelines.
• Lead and contribute to the development of key clinical trial documents, including but not limited to, clinical study protocols, informed consent forms, charters and study reports.
• Oversee study budgets and forecasts ensuring cost-effective execution without compromising quality or timelines.
• Lead and contribute (as applicable) to vendor selection and management, including CROs, central labs, and other study specific vendors.
• Ensure compliance with ICH-GCP, regulatory requirements across global regions, and internal SOPs.
• Collaborate with key internal and CRO partners to ensure alignment on study objectives and deliverables ensuring timely and compliant study execution.
• Proactively identify study specific risks and implement mitigation strategies.
• Support regulatory submissions and interactions with health authorities and IRBs/IECs.
• Provide leadership to study team members and mentor junior staff as required
  

This is a permanent position, based in Cambridge UK, with a competitive salary and benefits package.