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: www.amphista.com
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 pro-actively 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 prioritise; 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:
* Competitive salary
* 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
* Holiday buy scheme
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