Clinical Programme Lead
- Expired: September 25, 2021. Applications are no longer accepted.
Clinical Programme Lead, US
Achilles Therapeutics is a clinical stage biotech company focused on the development of T cell therapies targeting clonal neoantigens for the treatment of cancer. We use DNA sequencing data from each patient, together with our proprietary PELEUS bioinformatics platform, to identify clonal neoantigens specific to that patient and develop personalised T cell therapies. Originating from pioneering research at UCL, CRUK and the Francis Crick Institute, we are using our ground-breaking immuno-oncology approach to rapidly advance therapies, with our first products for Non-Small Cell Lung Cancer and Melanoma
The Clinical Programme Lead, US will be responsible for building and managing teams in a matrix environment across multiple therapeutic areas in oncology. The role is responsible for ensuring the operational execution of multiple programmes to quality and regulation, securing company critical timelines and data output. Tasks may extend beyond FIH programmes as the company evolves.
The role oversees and actively inputs across studies in multiple therapeutic areas, ensuring conduct according to all applicable regulations and business processes. The Clinical Programme Lead will provide direction and accountability for the US operational team and their delivery at regional and site level across studies, acting as the contact for region in regard to operational questions and escalations.
* Resourcing, line management, training, functional delivery and input on discussions around quality and operational delivery measurements
* Conduct regular discussions with direct reports and lead team meetings at regional and manager team level.
* Perform personnel related input including selection, development and evaluation of personnel to ensure optimal efficiency of operations of the team
* Assist with training for CRA Managers and Associates as required.
* Work with senior leadership including to communicate all critical issues, business growth opportunities, developing key relationships as well as providing input regarding budgeting discussions to drive productivity and quality within the region.
* Drive overall delivery to drive execution of service, client satisfaction, quality and efficiencies.
* Represent Clinical Operations at Sponsor and internal audits
* Work with a Quality to ensure SOPs, forms & templates are ready and current for clinical use
* Oversee the technical team to ensures regulatory inspection readiness within Achilles US operations and clinical sites as relevant.
* Lead data management activities across programs to ensure that clinical outputs are of consistently high quality including Oversight of clinical monitoring activities
* Ensure Vendor contracts are workable and accurate. Ensure in-house tracking and systems are in place for multiple programme delivery
* Support CPMs for processes of Site level approvals /Ethics/MHRA submission and maintenance (UK and EU)
* Performing Site initiations (where required), overseeing clinical trial and escalation point for vendors by CPM if required
* Clinical trial management plans ensure robust, current and fit for purpose
* Reviews and ensures activities conducted by clinical investigative sites across multiple programmes as they relate to clinical studies to ensure successful execution of the protocol.
* May be responsible for assignments of greater complexity (i.e., greater number of sites, site participating in more complex clinical studies, sites requiring more oversight of operational issues).
* Ensure that US teams are executing effective project management across stakeholders, deliverables and with external business vendors to ensure early sight
* In conjunction with Leadership and supporting CPMs effective oversight of the business vendors eg CRO, Biometrics , managing key metrics for performance per indication or across indications
* Oversee the process of Serious Adverse Events, ensuring medical review and reporting requirements are met
* Support to the budget planning and management as required
* In the country/region based, manage the team responsible for site identification, qualification, initiation, interim monitoring and study close-out visits
* Co-ordinate and lead CPMs for preparation and publication of data, reports and information, ensuring that these meet legislative, contractual and ethical requirements.
* This leader will be ideally suited to a biological sciences graduate with a higher degree, and a background in drug development in a pharmaceutical business environment.
* Industrial experience in clinical operations, with a focus on early phase oncology or advanced therapy trials
* Experience of leading trials within US and leading clinical teams
* Clinical Research experience that includes relevant experience as a Senior CRA or Principal CRA (in a Lead CRA role), or at least 2 years as a Project Manager, CRA Manager or equivalent job role preferably with IMP in immunotherapy oncology
* Knowledge of ICH-GCP guidelines and ability to review and evaluate medical data and Ensure adherence to GCP and other rules/regulations as appropriate
* Oncology experience (essential) and in immunotherapy or cell therapy (desirable)
* Excellent management skills, developed with a collaborative approach to driving performance and success in a global environment; working with global Achilles team proactively and collaboratively for delivery
* Demonstrated capabilities in leading and managing development projects and project management. Includes a track-record of successful operational drug project delivery working through third party collaborators, in-particular functional service provider models of management.
* Good understanding of regulatory and operational aspects of clinical studies.
* Well-developed written and oral communication skills, including the ability to prepare and present on the companys project data in the context of its financial activities.
We work fast and deliver a lot. To be successful at Achilles, you will be driven, comfortable dealing with ambiguity, have excellent interpersonal skills and the ability to build professional relationships.
A fearless pursuit of success and innovation
A focus on critical strategies to impact the company goals
Natural ability to influence, problem solve and drive teams and projects to conclusions
The desire to deliver impact every day, every week
Ability to build strong relationships at all levels, anticipate needs and work successfully with different working styles
Ultimately, a real obsession to learn.
This is a permanent position, offering a competitive salary and benefits package
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