Clinical Safety Lead Physician
The Clinical Safety Physician Lead should be able to perform medical review of all types of individual case safety reports (ICSRs) by writing an expert comment. The Clinical Safety Physician maintains distinctive quality and commitment as the operating philosophy in carrying out all processes., and continually seeks out ways to enhance medical expertise in team both internally and externally.
Your duties and responsibilities are likely to include:
You will provide medico-scientific and clinical strategic leadership for assigned product(s).Extensive expertise in spearheading and overseeing clinical development initiatives within biotech/pharma or academic environments, encompassing exploratory Phase I/II/III clinical trials.
MD or equivalent medical degree is required in addition to advanced knowledge and clinical training in medical/scientific area.
Has strong medical experience in overseeing and interpreting safety and efficacy clinical trial data and ensuring appropriate contact for study medical and patient safety aspects.
Having a solid understanding of the disease area is essential, along with the demonstrated ability to analyse, communicate, and present efficacy and safety data from clinical trials and the proven capacity to comprehend and interpret basic and clinical scientific research reports.
Demonstrable experience in health authority interactions (EMA, FDA, CDE, MHRA).
Providing strategic Clinical Safety input to drug development and post-marketing clinical programs
Collaboration with client team members to undertake safety surveillance activities and prepare high quality evaluation documents to describe safety findings.Ensuring your expert input to all elements of design and interpretation, including efficient use of tools and methodology.
Providing leadership to support project discussions with client governance boards, including interactions with Clinical Safety Peer Review Committee.
Lead the safety strategy for regulatory communication and provide oversight of higher-level documents to support submission activities.
Lead medico-scientific contributions to RMPs for assigned products and to Periodic Reports, including PBRERs, DSURs.
More broadly you are expected to participate in advisory discussions to support client's Clinical Safety teams in the development of their safety strategy and may be asked to represent Patient Safety in cross-functional discussions with internal and external collaborators.
Essential for the role- Degree in medicine and experience as a physician or academic clinician
- Extensive experience in Drug Development, Pharmacovigilance, with clear evidence of delivering to a high standard
- Detailed understanding of pharmaceutical safety, reporting and surveillance processes and strong experience of Patient Safety, as it relates to clinical trials and marketed products in any relevant field such as pharma, Regulatory Agency or Public Health agency
- Experience in designing, monitoring and implementing clinical trials and interpreting trial results
- Strategic leadership of complex drug projects
- Understanding of the medico-legal aspects of pharmacovigilance
- Shown leader of cross-functional delivery teams.
- Demonstrated ability to influence key business partners within and outside of company
- Proficiency with both written and verbal communications
- MD, PhD in scientific field
- Therapeutic area expertise and commercial understanding
- Extensive general medical knowledge
- Able to work across TAs and Functions
- Research background, including peer reviewed publications