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For Companies At a Glance
- Tasks: Lead global clinical development programs and manage external clinical vendors.
- Company: Amphista is a pioneering biotech focused on transforming therapeutics for human diseases.
- Benefits: Enjoy flexible benefits, private medical insurance, and a generous holiday allowance.
- Why this job: Join a passionate team dedicated to advancing innovative therapies and transforming patients' lives.
- Qualifications: Degree in life sciences with significant experience in biopharmaceutical project management.
- Other info: Opportunity to work in a hybrid environment with a focus on oncology.
The predicted salary is between 72000 - 108000 £ per year.
Amphista Therapeutics Ltd Great Abington/Little Abington, United Kingdom Research & Development Hybrid
Company Description
Amphista is a leading Europe-based biotech applying a pioneering next generation Targeted Protein Degradation technology to the discovery of therapeutics for human diseases. We are now advancing programs into the clinical development phase with the aim of bringing transformational medicines to patients. For more information, please visit:
Position
We are seeking a highly talented and experienced Clinical Operations leader who will provide strategic and operational leadership of global clinical development programs. You will have the ability to execute a successful strategy to deliver the progression of Amphista\’s portfolio of therapeutics and be comfortable with applying yourself to building and developing clinical operations at Amphista as we transition our lead programme into the clinic.
We are looking for someone who is comfortable with leading clinical operations, who shares our excitement about Amphista’s therapeutic portfolio, is passionate about advancing therapeutics, champions our culture, and supports our commitment to transforming patients’ lives.
Requirements
Responsibilities:
- Oversee the strategic & operational management of global clinical development programs from First in Human studies through to Proof of Concept, with an initial focus on Oncology.
- Build and manage a clinical operations function that delivers primarily through external clinical vendors.
- Manage external clinical service providers including selection, contract negotiation, and management of the ongoing relationship.
- Contribute to financial forecasting and budget allocation to deliver plans.
- Responsible for delivering to timelines, quality, and budget in alignment with the corporate goals and objectives.
- Accountable for plans for protocol design, feasibility assessment, study start-up, and execution phases of studies.
- Accountable for the coordination and delivery of study documents (e.g. Clinical Study Protocol, Informed Consent Forms, Clinical Study Reports).
- Contribute to regulatory documents, data analysis, study reports, and publications.
- Identify and proactively manage risks across clinical programs, developing and implementing mitigation strategies to ensure successful outcomes.
- Work closely with a cross-functional team to ensure a collaborative and high-performance culture.
- Serve as the main point of clinical study contact for internal stakeholders (e.g. therapeutic project team, CDO, CMO, Senior Leadership Team) and external stakeholders (e.g. CROs, consultants, clinical investigators, regulatory agencies).
Experience
- Degree in a relevant scientific discipline (e.g. life sciences, pharmacy, nursing).
- Significant experience of biopharmaceutical clinical project management and/or function leadership.
- Strong preference for candidates with early-stage clinical development experience.
- Experience of leading early phase clinical research and development, including global first-in-human studies in oncology.
- Expert project management skills, cross-functional engagement and organizational skills.
- Budget management expertise and strong financial & commercial acumen.
- Strong analytical skills with a data-driven approach to planning, executing, and problem-solving with an ability to prioritize; managing the details whilst keeping programme goals in mind.
- Excellent verbal and written communication skills, with experience writing regulatory and clinical documents and presenting to international scientific and medical experts.
- Successful history of collaborating and building relationships with key opinion leaders, study investigators, and their teams.
- Strong understanding of regulatory requirements and ICH/GCP guidelines.
- Flexibility and a willingness to do what needs to be done.
Nice To Have
- Experience working in a biotech environment.
- Experience in leading clinical programmes or studies in haematological malignancies.
- Experience in interacting with regulatory agencies.
What’s on offer
- Flexible Benefits including Private Medical Insurance, Life Assurance at 4 x Salary, Critical Illness Cover, and a Health Cash Plan.
- Discretionary Bonus Scheme.
- Allocation of Growth Shares.
- Pension scheme with 5% employer matched contribution.
- 25 days holiday + bank holidays.
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VP of Clinical Operations employer: Amphista Therapeutics Limited
Contact Detail:
Amphista Therapeutics Limited Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land VP of Clinical Operations
✨Tip Number 1
Make sure to familiarize yourself with Amphista's pioneering Targeted Protein Degradation technology. Understanding the specifics of this innovative approach will not only help you in interviews but also demonstrate your genuine interest in their mission.
✨Tip Number 2
Network with professionals in the biotech industry, especially those who have experience in early-stage clinical development and oncology. Engaging with key opinion leaders can provide insights into the role and may even lead to referrals.
✨Tip Number 3
Prepare to discuss your experience in managing external clinical service providers. Be ready to share specific examples of how you've successfully negotiated contracts and maintained relationships, as this is crucial for the role.
✨Tip Number 4
Highlight your analytical skills and data-driven approach during discussions. Be prepared to explain how you've used these skills to manage budgets and timelines effectively in previous roles, as this aligns closely with Amphista's goals.
We think you need these skills to ace VP of Clinical Operations
Some tips for your application 🫡
Understand the Role: Take the time to thoroughly understand the responsibilities and requirements of the VP of Clinical Operations position at Amphista Therapeutics. Tailor your application to highlight your relevant experience in clinical project management and leadership.
Highlight Relevant Experience: In your CV and cover letter, emphasize your significant experience in biopharmaceutical clinical project management, especially any early-stage clinical development experience. Be specific about your roles in leading first-in-human studies and managing external clinical service providers.
Showcase Your Skills: Demonstrate your expert project management skills and financial acumen in your application. Provide examples of how you've successfully managed budgets and timelines in previous roles, particularly in oncology or related fields.
Communicate Effectively: Ensure that your written communication is clear and professional. Since excellent verbal and written communication skills are essential for this role, consider including examples of regulatory documents or clinical reports you have authored or contributed to.
How to prepare for a job interview at Amphista Therapeutics Limited
✨Show Your Strategic Vision
As a VP of Clinical Operations, it's crucial to demonstrate your ability to develop and execute strategic plans. Be prepared to discuss your previous experiences in leading clinical development programs and how you aligned them with corporate goals.
✨Highlight Your Leadership Skills
Emphasize your experience in building and managing clinical operations teams. Share specific examples of how you've successfully led cross-functional teams and collaborated with external vendors to achieve project milestones.
✨Demonstrate Financial Acumen
Since budget management is key for this role, be ready to discuss your experience with financial forecasting and budget allocation. Provide examples of how you've managed budgets effectively while delivering quality results.
✨Prepare for Regulatory Discussions
Given the importance of regulatory compliance in clinical operations, familiarize yourself with ICH/GCP guidelines and be prepared to discuss your experience with regulatory documents. This will show your understanding of the regulatory landscape and its impact on clinical studies.
