Job Description

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The BenevolentAI Clinical Development Director (MD) will oversee and manage the clinical development of assigned programmes and drive the execution of BenevolentAI clinical trials. The MD will report to the Chief Scientific Officer and provide medical and strategic input for all clinical deliverables.

Responsibilities

• Leadership on clinical development strategies for assets both in the clinical stage (including the design of Ph2 proof of concept studies),, and those in discovery which require clinical planning to inform pre-clinical enabling activities.
• This will include but not limited to working across internal and external experts and stakeholders to combine technical considerations with asset and company strategy to design robust clinical plans and trial designs.
• Drafting clinical inputs on key documents, including Investigator Brochures, Protocols, and Clinical Development plans, and involvement in drafting Target Profiles (TPPs), including interaction with Commercial/Business Development colleagues.
• Supported by a clinical operations team, ultimate accountability for study delivery, and therefore responsible for the safety management of patients in BenevolentAI clinical trials and oversight of regulatory interactions, investigator communications, medical monitoring and pharmacovigilance vendors.
• Directly or via an external network of experts, provide insight into atypical strategies for evaluation of emerging hypotheses and validation of technology output, including use of biomarkers, omics signatures, and data led decision tools.
• Interaction with BD teams, and involvement in Due Diligence.

• Provide translational science, clinical insights, medical needs assessment, and clinical development guidance to both clinical-stage and preclinical projects, and input on applications of AI technology and tools to drug development.
• Work with Project leaders and Teams to evaluate technology-enabled drug candidates, and design innovative development pathways.

We are looking for:

• A minimum of 3 years of experience in Translational Medicine or Clinical Development
• Experience in designing asset-level clinical strategies/plans, including early clinical studies (Ph1, Ph2), and strong understanding of clinical trial methodology
• Strong understanding of regulatory and pharmacovigilance environment, and ideally experience as accountable safety lead for assets entering first-in-human trials.
• Experience inputting on behalf of clinical development functions for technical due diligence and business development activities preferred.
• Proven ability to interpret, discuss and present efficacy and safety data relating to clinical trials.
• Demonstrated ability to establish effective scientific partnerships with key stakeholders.
• Medical and science expertise in immunology desirable, and Gastroenterology preferred.
• Ability to work hands-on with other experienced colleagues in a flat structure, leading and influencing in a matrix setting.
• Ability to multi-task across projects. Ability to operate in an ambitious mixed Bio and Tech environment and enjoy the culture
• Confident to use personal expertise in areas outside of \xe2\x80\x9ccomfort zone\xe2\x80\x9d and to question \xe2\x80\x9clegacy\xe2\x80\x9d approaches (i.e. innovative)..

Training and Networks * Medical degree (MD or MD/PhD) with relevant clinical experience (Board Certified or MRCP/MRCS preferred).

• Excellent network of professional expert contacts, and KOL contacts (gastroenterology preferred).
• Existing interest in or experience with technology tools and machine learning are important.

BenevolentAI