Proclinical is advertising a vacancy with a multinational healthcare company that provides an innovative range of diagnostic solutions and medicines. The organisation is seeking a Digital Biomarker Science and Study Manager to join their team in Switzerland on a contract basis.
The Digital Biomarker Science and Study Managerwill oversee particular aspects of an overall program or a group of products. Applicable tasks will include signal evaluation, safety related activities associated with new drug applications/regulatory filings, benefit-risk assessment, and safety risk management. The Digital Biomarker Science and Study Manager will occasionally act as Safety Science Leader (SSL), which will including representing the safety science department on the Global Development Team (GDT), Lifecycle Team (LCT), Clinical Science Team (CST), Established Products Team (EPT), and leading the cross-functional Safety Team.
Job Responsibilities:
- Developing timely and scientifically sound clinical portions of a Product Development Plan (PDP), developing and maintaining an expert understanding of the safety profile of the assigned product(s), as well as understanding the relevant strategic context.
- Contributing to developing the product safety strategy and providing drug safety input into the Clinical Development strategy aligned with the safety strategy and risk management plans, such as Integrated Safety Management Plans.
- Reviewing clinical protocols, study reports, Investigator's Brochure (IB), informed consent form (ICF), and other related documents to ensure alignment with the safety strategy and ensure the appropriateness of risk management strategies and risk communication.
- Contributing to regulatory authority submissions (e.g., Investigational New Drug/IND Applications) by reviewing safety data and preparing relevant sections of the filing and submission packages in consultation with a safety science physician.
- Participating in and providing input for Drug Monitoring Committee (iDMC) or internal Monitoring Committee (IMC) meetings.
- Preparing and presenting important safety issues to the Drug Safety Committee, Development Review Committee, and other internal and external review and governance committees as needed.
- Contributing to the development and oversight of the signal detection plan (SDP) and the signal detection and assessment activities.
- Supporting the Safety Science Leader or Director/Group Head, Safety Science, or be responsible for the development of the RMP/ISMP or Risk Evaluation and Mitigation Strategies (REMS) for submission to regulatory health authorities (HA).
- Preparing and reviewing periodic aggregate safety reports (Periodic Benefit Risk Evaluation Report/PBRER, Periodic Safety Update Report, EU Renewal, and other Safety Reports) and benefit-risk assessments.
- Preparing and maintaining safety assessments and drug safety reports for signals or issues (product quality) or in response to HA requests.
- Working in partnership with CSSD team members to meet Safety Science deliverables.
- Medically interpreting emerging clinical safety data for signal detection and signal evaluation purposes and determining the medical significance of any findings.
- Determining the casual relationship of events for Individual Case Safety Reports when the task resides in PDS.
- Defining the safety question or issue requiring medical safety assessment.
- Reviewing and approving drug safety reports, PBRER/PSUR and other aggregate reports.
- Performing medical impact assessments for product quality issues.
- Determining medical impact of nonclinical safety findings.
- Reviewing and approving (if needed) clinical protocols to ensure medical appropriateness of safety relevant sections such as inclusion/exclusion criteria, safety monitoring and management, and scheduling assessments
- Providing medical interpretations of whether/how risks impact the overall risk-benefit balance.
Skills and Requirements:
- An MD degree and postgraduate training, with 2 or more years of clinical or academic experience.
- Speciality training and board certification strongly preferred.
- Demonstrable experience in the principles and techniques of data analysis, interpretation, and clinical relevance.
- Experience publishing in a referred journal preferred.
- A thorough understanding of GxP and regulated process and end-to-end clinical trial lifecycle.
- Capable of working independently, analysing, working with attention to detail, process and prioritise sensitive complex information, and solve problems.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency in MS Office.
To Apply:
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 contact Andrea Rotmistrovsky at +44 203 854 0675 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.
#LI-AR1
.png)
.png)
