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Clinical Programme Leader at BenevolentAIgo back to Data and Product Jobs
With over 35 nationalities and a range of backgrounds represented in our Benevolent team, we aim to build an inclusive environment where our people can bring their authentic selves to work, be respected for who they are and the exceptional work they do. We welcome and actively encourage applications from all sections of society and are committed to offering equal employment opportunities regardless of sex, race, religion or belief, ethnic or national origin, marital, domestic or civil partnership status, sexual orientation, gender identity, parental status, disability, age, citizenship, or any other basis. We see our diversity as an asset as we tackle challenging problems that bridge the gap between drug discovery and technology.
This is an exciting opportunity to join an expanding group supporting a growing pipeline of early stage clinical projects. The team is looking for a motivated individual with a track record of transitioning pre-clinical projects to first in human trials and adept at overseeing CRO activities. Must be self-motivated, driven and proactive with strong organizational skills and able to work with limited supervision.
Reporting to the VP Clinical Programmes, the successful candidate will manage the activities of suppliers to deliver high quality studies on time and to budget.
- Operational delivery of clinical development programme according to approved programme objectives, timelines, resource plan (budget, people) and quality.
- For FIH studies, work closely with internal scientific, translational and clinical colleagues to deliver fit for purpose Phase I/Ib clinical studies in line with related regulatory requirements and internal quality processes.
- Overseeing the execution of clinical trial activities in accordance with Good Clinical Practices. Ensure compliance of clinical trials with national and international regulatory requirements and company SOPs.
- Provide oversight and accountability of CROs and third-party vendors assigned to a program and play an active part in CRO selection and review of RFP’s when required, ensuring the appropriate CRO is identified and properly vetted
- Reviewing pre-study, study initiation, interim monitoring visit and at study closeout visit reports. Provides close oversight on the findings on the monitoring reports and loops back with broader team to provide updates.
- Ensuring high performance, adherence to protocol and efficiency of the CRO clinical team and investigator sites through performing of co-monitoring /accompanied site visits. Work to proactively address trial conduct issues and enrollment problems, as necessary.
- Develop and manage the overall study budget, forecast spend, and ensure study costs stay within predicted spend and identify and communicate study issues that will impact budget, resources and timelines.
- Maintaining the Sponsor Oversight File and the oversight of the TMF. Ensures TMF is maintained and complete at the end of the study. Perform periodic QC of the TMF
- Reviewing study metrics and manage risks for successful completion of studies. This includes reviewing study data and reports for trends and escalating issues as appropriate.
- Assist and contribute in authoring company study protocols, protocol amendments and other related study documents, as required, from the initial scientific discussion.
- Contribute high level input to regulatory documents such as Investigator’s Brochures and development safety update reports (DSUR); with the ability to create and/or update these where necessary and asking for input where appropriate.
- Assist in SOP and working instruction development, review and approval within the company.
- Review and approve CRFs, IRTs and other relevant specifications from a clinical perspective, ensuring the successful support of data collection.
- Contribute to IND development and other regulatory documents including but not limited to briefing books, regulatory submissions and responses.
- Contribute as required to the scientific, intellectual property, and business development aspects of the company’s activities in order to help fully realize their potential, such as; biomarkers, trial designs, FIH study designs/operational implementation and BLA/MAA filing support.
We are looking for someone with:
- Ability to perform in a small dynamic company environment with an ability to work flexibly and independently.
- Minimum of a Bachelor’s Degree in a Scientific Discipline
- Minimum 15 years’ experience
- Understanding of the drug development processes in the Pharma Industry environment.
- Excellent communication skills, able to collaborate with internal and external colleagues at all levels.
- Experience in oncology development programmes desired.
BenevolentAI (AMS: BAI) is a leading, clinical-stage AI-enabled drug discovery and development company listed on the Euronext Amsterdam stock exchange. Through the combined capabilities of its AI platform, scientific expertise, and wet-lab facilities, BenevolentAI is well-positioned to deliver novel drug candidates with a higher probability of clinical success than those developed using traditional methods. The Benevolent Platform™ powers a growing in-house pipeline of 13 named drug programmes and over 10 exploratory programmes, and it maintains successful collaborations with AstraZeneca, as well as leading research and charitable institutions. BenevolentAI is headquartered in London, with a research facility in Cambridge (UK) and a further office in New York.
We share a passion for being part of a mission that matters, and we are always looking for curious and collaborative people who share our values and want to be part of our journey. If that sounds like a fit for you, hit the ‘apply’ button and join us.
Want to do a little more research before you apply?
Head over to our Glassdoor page to learn about our benefits, culture and to find out what our team think about life at Benevolent. You can also find out more about us on LinkedIn and Twitter.
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