The GARDP Clinical Scientist will provide medical and scientific study and project support primarily for clinical studies (phase I to IV) in a clinical project but also for enabling scientific workstreams at the cross project and portfolio level. She/he will work in collaboration and with oversight from the lead physician at the study and the clinical project level to develop clinical science strategies in support of the clinical development plan. Priority activities for the 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 scientific quality, data integrity and patient safety and alignment with GARDP procedures.
Preparation and/or review of regulatory documents, study reports and scientific publications.
The Clinical Scientist may also lead implementation of drug/treatment project level identified by the Project Lead and/or Medical Director/Medical Lead.
Tasks and Responsibilities
Clinical Study Medical oversight – General
Medical and Clinical science oversight of specific study activities providing medical/scientific guidance during the execution of the study as directed by the 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 monitoring 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 medical/protocol issues.
At study level provide safety monitoring support with overview provided by Drug Safety Scientist and Medical Lead.
Support the track and reconciliation of SAEs across a study.
Support timely communication of safety issues to sites.
Review and approval of patient narratives as agreed with the 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, medical lead, statisticians, and others where appropriate.
Draft and provide specific medical/protocol training for investigator meeting, site personnel for initiation visits.
Provide medical and scientific input on country and site feasibility as requested by the study operations lead/clinical trial manager and/or medical lead.
Support the preparation and review of clinical documents including informed consent templates.
Clinical and laboratory data review and interpretation
Provide clinical input to study design aspects including data collection, analysis, and database set-up.
Provide input for the design of the Statistical Analysis Plan (SAP) and the clinical data output.
Drafts plan for medical review of data to focus on identifying trends and supporting interpretation.
Responsible for review of patient level clinical and microbiological data across a study and for coordinating with 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
Support execution of the global study management plan from a medical/safety/scientific perspective.
Provide scientific and medical input and review into the monitoring plan for study to ensure it recognizes the specifics including appropriate endpoints related to antibacterial clinical trials.
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.
Ensure regulatory compliance and GCP adherence at the study level with regard to medical/scientific issues.
Regulatory and quality compliance
Provide scientific/medical input, review and editing of clinical study reports (CSR).
Contribution to regulatory filings and responses including briefing documents, IND updates, IB, PSURs, paediatric investigational 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.
Experience and technical skills
Minimum 6 years' relevant experience in pharma or academic.
Proven ability to lead and work effectively in a team environment and matrix structure.
Significant experience in clinical research from industry or academia 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 ability to manage medium/large projects with budget management.
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.
Experience
Minimum 6 years' relevant experience in pharma or academic.
Proven ability to lead and work effectively in a team environment and matrix structure.
Experience of working in private sector and/or public and collaborative research partnerships is highly desirable.
Education
MD, Ph.D, Pharm.D or graduate degree with equivalent in experience.
Other Requirements
Fluency in English as the professional working language.
Proficiency in local languages is advantageous.
Very good knowledge of Microsoft Suite.
To Apply:
Please submit your application using the online form.
Deadline for applications: 10.10.2024.
All candidates will be reviewed after closing date.
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