ProClinical is happy to advertise a vacancy for a Clinical Scientist position with an internationally renowned pharmaceutical company that specialises in developing and producing medicines and vaccines for a wide range of therapeutic areas including oncology, cardiology, and immunology. This company is looking for an enthusiastic and dedicated Clinical Scientist (CS) to join their remote team in the UK.
The Clinical Scientist will provide leadership in clinical epidemiology study execution, ensuring consistency of approach, conduct, result reporting, and oversight of core team activities within one or more vaccine asset programs. They will also execution and manage their studies, whilst taking responsibility for numerous epidemiological studies run either through company sponsorship or as Research Collaborations.
The Clinical Scientist also has a strategic role in partnership with Epi/Medical/Regional to develop epidemiological plans and study strategies in support of the Clinical Development and Life Cycle plans. Data generated by epidemiological studies is critical evidence needed to obtain optimum Vaccine Technical Recommendations at the country level, including National Immunisation Programs.
- Representing CS line in program-wide functions on Clinical Project Team, Medical Sub-Committee, Clinical Study Teams, Asset Team, Program Teams, and Regulatory Strategy teams.
- Co-leading Epidemiology Sub Team meetings, whilst contributing to discussions to ensure consistency across all programs.
- Providing line management support for other Clinical Scientists within the program.
- Reviewing work, developing staff, ensuring appropriate succession planning, and providing ongoing feedback.
- Overseeing short-and-long-term resource planning, priority setting, and filling of resource and skill gaps to address the needs of the program(s).
- Using expert knowledge of epidemiologic and vaccine clinical trials, providing oversight of operation strategic partner involvement at a program or study level.
- Identifying issues in a timely manner, leading implementation of complex solutions, and/or escalating as appropriate whilst working with Clinical Leads, Medical/Epi Leads, and Partner representatives.
- Influencing management/senior staff decisions and acting as Subject Matter Expert on CS decisions impacting a program; this will potentially include the Epi and Medical/Scientific Affairs groups.
- Collaborating with Epi and Medical leads, along with other team members, on developing an Epidemiology Plan, and providing input on asset strategy and LifeCycle Development Plan for epidemiological studies.
- Providing CS leadership roles in preparation of regulatory submissions, responses to regulatory queries, and in preparation for program regulatory inspections and audits.
- Collaborating with the Clinical Lead and Medical/Epi Lead, preparing strategy decisions, presenting and discussing data at relevant team, governance, external consultants, KOLs, and potentially regulatory meetings.
- Representing Vaccine Clinical Affairs, and taking the lead on company-wide, global process improvement initiatives, whilst championing process enhancements and solutions for complex issues.
- Leading change for Vaccine Clinical Affairs on new company initiatives.
Skills and Requirements:
- At least a BA/BS Degree in Life Sciences or health related field, with an MS or PhD preferred..
- At least 7 years of practical experience, or 4 with an MS/MpH/MD.
- Demonstrable experience in epidemiology study design, conduct, and analysis.
- Significant experience leading operational and/or strategic study teams.
- Significant experience with working independently and collaborating with multiple functional groups within and outside the business line.
- Demonstrably advanced ability and level of experience with working across multiple studies for incorporation of consistent medical/scientific concepts in multiple protocols, ensuring they meet strategic program objectives
- An advanced knowledge of the clinical research process and GCP from previous experience in the clinical research field.
- Prior infectious disease, microbiological, or infection control experience.
- A thorough knowledge of vaccine therapeutic area.
- Independently authored clinical protocols and other clinical study documents.
- A working knowledge of statistics, data analysis, and data interpretation.
- Experience in managing external vendors for clinical and/or epidemiological studies.
- Exceptional communication, persuasion, and cross-functional collaborative skills, along with proficiency in oral and written English.
- Proficiency in MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Luke Saner on +443300524502 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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