Associate Director, Medical/Safety Science

Who We Are: 

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. Calico’s highly innovative technology labs, its commitment to curiosity-driven discovery science, and, with academic and industry partners, its vibrant drug-development pipeline, together create an inspiring and exciting place to catalyze and enable medical breakthroughs.

Position Description:

The Associate Director, Medical/Safety Science will take on the responsibility for the medical safety management efforts including medical review of ICSRs for new and ongoing clinical development programs. The role entails the development of signal detection monitoring, product risk-benefit assessment, and safety assessment activities for Calico products, as required. The position is responsible for actively identifying and communicating emerging safety issues and providing support in signal detection and risk/benefit evaluation for clinical programs. The individual will collaborate closely with key stakeholders within one or more cross-functional clinical development teams. Their responsibilities include establishing and nurturing a work environment that emphasizes quality, learning, respect, open communication, collaboration, integration, and teamwork.

Responsibilities:

• Conduct medical review and assessment of all safety related data (SAE, SUSAR, AESI, pregnancy etc.)
• Ensure medical accuracy of case narratives, coding and medical sense of all cases and ensures appropriate queries are raised for a comprehensive medical review
• Provide oversight over the monitoring of clinical trial safety and monitor site compliance with protocol-specified measures intended to ensure the safety of subjects
• Provide required medical oversight to safety operations managed by external partners (CRO and consultants)
• Contribute to the preparation of clinical protocols, clinical study reports and statistical analysis plans, Investigator Brochures, Reference Safety Information, Informed Consent forms, DSURs and other documents as required
• Demonstrate strong experience analyzing aggregate safety data within clinical programs and review all appropriate safety data from various sources throughout the product development lifecycle
• Lead the Joint Safety team meetings and signal evaluation planning for Calico molecules
• Oversee implementation of safety signal detection and introduce new concepts of signal detection as the safety database grows, including platform specific signal detection
• Perform signal evaluation, assessment and tracking and trending of risk assessments and additional mitigation measures
• Serve as final reviewer for safety deliverables prior to database locks (coding, SAE reconciliation) 
• Partner with clinical operations and other functional areas for the successful implementation and execution of clinical studies
• Provide scientific and medical support throughout conduct of a clinical trial; respond to clinical questions from sites, IRBs/IECs, Health Authorities, and CROs
• Review and provide input on MedDRA coding of AEs, product package labeling, Company Core Safety Information (CCSI)
• Be responsible for responses to queries from regulatory authorities or health care professionals on safety issues and any legal queries and requests involving safety issues
• Assist in the creation, review and implementation of new SOPs, Work Instructions, guidelines, documents, and other tools pertaining to safety
• Perform root cause analysis and initiate corrective and preventive action (CAPA) measures when appropriate
• Stay current with international pharmacovigilance requirements and guidelines (focus on FDA and EMA)
• Mentor other drug safety staff and CRO to ensure current understanding of the Drug Safety and improvement of quality of adverse event reports
• Occasional business travel may be required
• Other duties as assigned

Position Requirements:

• Health care professional degree required (MD or MD equivalent)
• Minimum 7+ years of safety/clinical development experience in the biopharma industry in both clinical trial and post marketing environment
• Proven experience with and knowledge of clinical research and global regulatory requirements with a focus on safety reporting (e.g., IND, BLA filings, etc.), practices governing expedited and periodic safety reporting, signal generation, safety evaluation and risk management activities
• Well versed in clinical aspects of FDA and other global regulatory guidance and regulations
• A solid grasp of safety and pharmacovigilance principles with respect to early clinical trials, data analysis and interpretation is required
• Experience with safety databases (i.e., Argus, Aris) and safety coding dictionaries (i.e., MedDRA, WHODRUG)
• Ability to take initiative yet work collaboratively on multiple projects and with partner companies to achieve goals in compliance with PV and regulatory requirements and safety data exchange agreements
• Demonstrated competence in obtaining, analyzing, disseminating, and reporting safety information in compliance with global regulations
• Well-developed presentation, communication, and interpersonal skills, including strong oral and written communication skills
• A commitment to developing drugs that will make a difference in the lives of patients
• Strong team player in a multifunctional, multicultural, growing organization
• Ability to travel up to 20% of the time domestically and internationally
• Must be willing to work onsite at least 4 days per week

The estimated base salary range for this role is $224,000 - $235,000. Actual pay will be based on a number of factors including experience and qualifications. This position is also eligible for two annual cash bonuses.