Senior Clinical Scientist

Overall Purpose:

The GARDP Snr Clinical Scientist (MD) will provide medical, clinical and scientific study and project support primarily for clinical studies (phase I to IV) within a clinical project(s), but also flexibly to enable and support scientific workstreams at the cross project and portfolio level.  They will work in collaboration and with oversight from the Medical Lead at the study and the clinical project level to develop clinical science strategies in support of the clinical development plan.  Priority activities for the Snr Clinical Scientist will include:

·       Study and protocol design, implementation strategy, and training,

·       Clinical data review and interpretation

·       Safety review and coordination with Drug Safety

·       Clinical study implementation, support and oversight to ensure patient safety, scientific validity and data integrity/quality in alignment with GARDP procedures.

·       Preparation and/or review of study-specific and regulatory documents, study reports and scientific publications.

The Snr Clinical Scientist (MD) may also lead implementation of a drug/treatment project identified by the Project Lead and/or Associate Director Medical Sciences/ Medical Lead.

Contribution

They are accountable for delivering clinical/Medical Science support and strategies via clinical project and study level workstreams directly or indirectly via external collaborations or via oversight of expert services/consultants.

Scope of Work (Results)

The role delivers integration of clinical science with clinical operations, interpretation of evidence, data and advice to support the performance of assigned clinical studies and project workstreams.

Clinical Study oversight – General

·       Medical/clinical science oversight of specific study activities providing scientific guidance during the execution of the study as directed by the Associate Director Medical Sciences/Medical Lead role for the study including those conducted via a CRO.

·       Co-ordination of Medical Science support and integration with operations and CRO activities

·       Provide the medical input to the development of the Site Monitoring Plan

·       Write the Medical Monitoring Plan and liaise with programmer to determine data outputs needed to execute this plan

• Answers specific site management protocol questions as needed
• Assists in medical issue resolution (study wide, escalated regional/site)
• Provides input during vendor selection for specific clinical/protocol issues

·       At study level, provide safety monitoring support with overview provided by Drug Safety Scientist and Associate Director Medical Sciences/Medical Lead

·       Support the track and reconciliation of SAEs across a study

• Support timely communication of safety issues to sites
• Write and/or review patient narratives as agreed with the Associate Director Medical Sciences/Medical Lead and Drug safety scientist

Clinical study design, protocol development and set-up

• Lead design strategy discussions where appropriate
• Draft study design concepts/synopsis, protocols and amendments in collaboration with study operations lead/clinical trial manager, Associate Director Medical Sciences/Medical Lead, statisticians, and others where appropriate
• Draft and provide specific clinical/protocol training for investigator meeting, site personnel for initiation visits
• Provide scientific input on country and site feasibility as requested by the study operations lead/clinical trial manager and/or Associate Director Medical Sciences/Medical Lead
• Support the preparation and review of clinical documents including informed consent templates

Clinical and laboratory data review and interpretation

• Provide medical/clinical input to study design aspects including data collection, review, analysis, and database set-up
• Provide input for the design of the Statistical Analysis Plan (SAP) and the clinical data programmed output
• Responsible for review of patient level clinical and microbiological data across a study, to focus on identifying trends and supporting interpretation, in co-ordination with Associate Director Medical Sciences/Medical Lead for study level review
• Support for end of study procedures including table and listings design and review, blind data review, patient/case evaluability reviews
• Support and participate in study analysis including interim analysis, DSMB and IDMC management and preparation for final analysis and clinical interpretation meeting.

Clinical study implementation

• Ensure regulatory compliance and GCP adherence at the study level with regard to medical/scientific issues
• Support execution of the global study management plan from a clinical/safety/scientific perspective
• Provide medical and scientific input and review into the monitoring plan for study to ensure it recognises the specifics including appropriate endpoints related to antibacterial clinical trials
• Provide medical/clinical input and support for development of non-conformance plans (e.g., protocol deviation plan) and periodic review and management of non-conformance during the clinical study
• Work with the study Operations Lead/Clinical Trial Manager to ensure study level issues related to medical/safety concerns are resolved, including corrective action where appropriate.
• Support the study Operations Lead/Clinical Trial Manager and Project leads to develop study level enrollment plan and maintenance of study timelines
• Participates and supports ongoing training for study management, monitoring and site staff with the study team members.
• Ensure any standard processes, tools, and procedures developed are used consistently across the study.

Regulatory and quality compliance

• Provide medical/clinical/scientific input, review and editing of clinical study reports (CSR).
• Contribution to regulatory filings and responses including briefing documents, IND updates, IB, D/PSURs, paediatric investigational/study plans.
• Participate in license approval regulatory submissions including drafting of relevant sections
• Understand and apply applicable regulatory requirements (e.g. US-FDA and EMA) for antibiotic development
• Support study operation team in understanding regulatory and ethics requirement for protocol approval and study set up at key GARDP country level
• Participate in inspection readiness activities and support preparation of audit responses

Reporting line

• To Associate Director Medical Sciences or Medical Lead.

Interactions

Works with the GARDP Drug and/or Treatment project and study leads and external partners to provide transversal medical/clinical science support.

• They have a representational role through the presentation of projects and maintain productive relationships by projecting the image of GARDP as a credible partner.

Experience and technical skills

• Minimum 6 years' relevant experience in pharma and/or academic clinical trials; with a preference for antibiotic clinical development
• Experience of working in collaborative research partnerships is desirable
• High level understanding of the ethical and compliance requirements for clinical research
• Ability and experience with drafting clinical study documents including protocols with responsibility for medical /scientific sections.
• Experience with co-leading and working as part of a study operational team
• Has working knowledge of statistics, data analysis, and data interpretation

General skills and attributes:

• Has excellent written and oral communication in multicultural, multi-lingual environments. and cross-functional collaborative skills
• Strong ability to work effectively as part of a multicultural cross-functional collaborative teams
• Strong ability to use initiative, prioritize, multi-task, and work well under pressure to meet deadlines
• Clear and systematic thinking that demonstrates good judgment and problem-solving competencies
• Well organized and structured with ability to work independently with minimal supervision
• Strong analytical skills
• Strong ability to provide high level support in project/program delivery
• Strong management, negotiation, and advocacy skills
• Strategic thinking and leadership abilities
• Has autonomy for taking actions and decisions
• Strong ability to interact with external stakeholders

Education

• MD, (PhD desirable)

Other Requirements

Fluency in English as the professional working language

• Proficiency in local languages (e.g., French) is advantageous