Calico (Calico Life Sciences LLC) is an Alphabet-founded research and development company whose mission is to harness advanced technologies and model systems to increase our understanding of the biology that controls human aging. Calico will use that knowledge to devise interventions that enable people to lead longer and healthier lives.
The Director/Senior Director of Drug Safety is responsible for leading the Drug Safety function within the Clinical Science organization including supervising key drug safety personnel at CROs and development partners. This individual will work with key stakeholders within Calico and its development partners to develop safety surveillance strategy for products under development including developing safety management plans for clinical trials, proactively identifying and communicating emerging potential and/or urgent safety issues and support signal detection and risk/benefit evaluation for clinical programs. This individual will have oversight of Serious Adverse Event (SAE) processing and ensure safety reporting in accordance with applicable regulatory requirements, Good Clinical Practice (GCP), and standard operating procedures (SOP). This individual must effectively interface cross-functionally at all levels within Calico as well as with external collaborators, partners and with Health Authorities on drug-safety related topics. The successful candidate should have the ability to work in a dynamic, changing environment to meet corporate and patient needs. The Drug Safety Director/Senior Director will participate/drive the development of safety surveillance strategies for assigned program(s)/indication(s) while ensuring a positive and collaborative team environment.
In coordination with the Head of Clinical Science, will lead or represent the Drug Safety function in cross-functional projects and study teams that develop safety surveillance strategies for the safe conduct of clinical trials, monitoring the safety profile of products, and contribute to the assessment of risk/benefit for products in development
Assist Clinical Scientists to develop medical monitoring strategies for clinical studies and clinical programs
Lead the evaluation and management of safety signals emerging from any data source.
Oversee, prepare, and/or review safety documents including scheduled periodic/annual safety reports, signal evaluation reports, risk management plans and other safety-related documents
Contribute to and/or review relevant clinical study documents including Investigator’s Brochures, Clinical Study Reports, Statistical Analysis Plans, clinical protocols, informed consent forms, and IND/CTA and NDA/BLA submission documents, case report forms, data tables, listings and figures, medical monitoring and safety management plans
Formulate responses to Health Authority inquiries with information relevant to product safety
Implement and maintain Safety Data Exchange Agreements with potential partners
Provide oversight for CRO-delegated safety activities, including safety event case processing, medical review and reporting of individual case reports
May participate in the assessment of CROs and study vendors
Maintain safety inspection readiness
Build and manage a Drug Safety team, as the organization grows
Develop or contribute to development of departmental process improvement projects, including policies, Standard Operating Procedures and other relevant safety documentation
Must be willing to work onsite at least three days per week
MD / PharmD or equivalent
At least 8 years of experience in clinical drug development in the biotech/pharmaceutical industry performing the responsibilities described above
Excellent understanding of clinically relevant ICH GCP guidance, FDA and EMA regulations
Working knowledge of operational aspects of safety data exchange agreements, safety management plans, safety event case processing, and safety event reporting to effectively provide oversight for pharmacovigilance activities delegated to CROs or development partners
Ability to perform responsibilities largely independently
Proven leadership skills and ability to bring out the best in others on a cross-functional team
Able to provide effective leadership through influence across organizations on partnered programs
Detail-oriented mindset with excellent oral and written English communication skills
Calico requires all new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Calico will consider requests for Reasonable Accommodations.