Safety Science Associate Director in Hertfordshire
Stephanie Maccioni at CK Group is recruiting for a Safety Science Associate Director to join a leading Pharmaceutical company based in Hertfordshire, on a full time, permanent basis. The role has flexible home working due to being a part of an established global team.
The Safety Science Associate Director will work under the supervision of a Safety Science Group Director and will be responsible for particular aspect(s) of an overall program or a group of products. Applicable tasks are not limited to those described, may vary by product(s) assigned and may include signal evaluation, safety related activities associated with new drug applications/regulatory filings, benefit-risk assessment and safety risk management.
As a Safety Science Director, you will have the following responsibilities:
- Develop timely and scientifically sound clinical safety portions of a Product Development Plan (PDP), develop and maintain an expert understanding of the safety profile of the assigned product(s) as well as understanding of the relevant strategic context (e.g., disease under study, safety profile of competitors, mechanism of action).
- Contribute to development of the product safety strategy and provide drug safety input into the Clinical Development strategy aligned with the safety strategy and risk management plans (e.g., Integrated Safety Management Plan (ISMP), RMP).
- Review of 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.
- Contribute to regulatory authority submissions (Investigational New Drug/IND applications, New Drug Applications/NDAs, Marketing Authorization Applications/MAAs, Variations, Renewals, etc.) by reviewing safety data and preparing relevant sections of the filing and submission packages in consultation with a safety science physician.
- Accountable for signal detection, evaluation and decision-making across the lifecycle of the product.
As a Safety Science Director, you will have the following qualifications, skills and experience:
- Bachelor's Degree in life sciences required; Advanced Clinical/Science Degree preferred (e.g., PharmD, PhD, MSN, MPH, DDS, DVM, etc.).
- Experience working within drug safety, clinical development or medical affairs experience in the pharmaceutical or related industry.
- Experience in the principles and techniques of data analysis, interpretation and clinical relevance.
- Experience in the oversight of pediatric clinical trials is desirable.
- Experience in early development safety during the translational research period is desirable.
- Understanding of GxP and regulated processes and end-to-end clinical trial lifecycle.
Full job description is available upon request.
For more information or to apply for this position, please contact Stephanie Maccioni on 01438 768713 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 44945 in all correspondence.