Find and Apply for Associate Director Jobs

My client is a global biopharmaceutical company with a goal of contributing to healthcare innovation and environmental sustainability. They are focused on improving people’s quality of life, specialising in Oncology, neurology, rare diseases, ophthalmology and immunology. There is an opportunity for an Associate Director / Director Safety Scientist to join their team.

As a highly motivated individual, you will support early and late phase development activities as a member of the safety team, providing essential safety oversight and input into all aspects of study management across the entire development and marketed portfolio. In the post-market setting, this may include signal evaluation, safety-related activities associated with new drug applications/regulatory filings, benefit-risk assessment and safety risk management.

- Develop and maintain an understanding of the safety profile of their assigned product(s) or therapy areas

- Responsible for individual and aggregate case reporting activities including ICSR case management (medical review) and aggregate reporting (i.e. DSUR, PBRER)

- Responsible for signal detection and management activities and contributing to the strategy and review of safety assessments and drug safety reports for signals or issues (inc, product quality) or in response to Regulatory Authority requests

- Contributing to risk management activities including preparation and maintenance of CCDS, labeling document maintenance, risk communications, RMP, REMS

- Contributing to study management from a safety perspective through SMT/PET and document review and maintenance across the development continuum (early phase to post-marketing studies), including PASS

- Contribute to regulatory authority submissions (Investigational New Drug/IND applications, New Drug Applications/NDAs, Marketing Authorisation Applications/MAAs, Variations, Renewals, etc.) by reviewing safety data and preparing relevant sections of the filing and submission packages in consultation with the team

- Establish and maintain collaborative working relationships with all key stakeholders, and internal and external customers and ensure the same across relevant teams

- Consistently comply with all governing laws, regulations, standard operating procedures (SOPs) and other guidelines

Primary life sciences degree and relevant postgraduate degree preferred

Proven drug safety, clinical development experience in the pharmaceutical industry, ideally as a Safety Scientist

Understanding of GxP and regulated processes and end-to-end clinical trial lifecycle

Strong orientation towards process improvement and cross-functional teamwork

Excellent communication skills, both written and verbal

Perform data analysis / statistical methods to evaluate, interpret and present scientific data with clarity

Good presentation skills, effective at summarising and presenting the key considerations and decision points

Understanding of project management methodology

Before you apply for this position, it is vital that you are in possession of a UK passport or relevant visa to work without restrictions in the UK and residing in the UK.

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call Roberta Atkins on 03330106292