Associate Safety Director, Pharmacovigilance
Safety | South San Francisco, CA | Full Time
Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) therapies for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.
Reporting to and working closely with the Vice President of Pharmacovigilance, the Associate Safety Director supports essential medical safety oversight and input into all aspects of signal management across the Allogene development portfolio. You will be self-motivated, have strong communication and teamwork skills along with a robust ability to work independently, problem solve, manage work priorities, build collaborative team relationships at all levels, and remain flexible to the needs of the teams and projects. You will be someone who can roll up their sleeves and get the job done.
Responsibilities will include:
- Signal detection, evaluation, and management from clinical trials
- Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection and write up analysis results
- Collaborate with other functional area, including but not limited to Biostatistics, Clinical, Translational Sciences, Research and Regulatory Affairs to identify, evaluate, understand and risk manage safety signals.
- Participate in the authoring of relevant safety sections of clinical protocols, Investigator's Brochure (IB), informed consent form (ICF), statistical analysis plans, study reports and other clinical study-related documents to ensure alignment with the safety strategy and risk communication.
- Author and review aggregate reports e.g. (DSUR) in collaboration with the aggregate report writers.
- Participate in the development of safety-related data collection forms for clinical studies and ensure consistency in safety data collection
- Contribute to health authority and other safety related query responses including literature searches
- Collaborate in the planning for and creation of an effective signal tracking process that fully documents signaling activities and can be used for regulatory inspection
- Provide leadership in the development, implementation, and maintenance of robust procedures for the planning, preparation, and submission of high-quality safety reports
- Medical review of individual case safety reports (ICSRs) in a timely manner to ensure on time submission to regulatory authority.
Skills and Qualifications:
- This is typically a role best suited to a PhD, RN, PharmD or MD with a minimum of 6 years’ experience in Pharmacovigilance who possesses:
- Experience working on oncology trials, ideally cellular therapies
- Experience in IND applications and early development
- Expertise in US and international regulations governing drug safety
- Experience in signal detection, evaluation, aggregate data analysis, and interpretation in clinical trials.
- Excellent interpersonal, team management, and leadership skills.
- Excellent communication skills, both written and verbal.
- Knowledge of Pharmaceutical dictionaries and understanding of MedDRA coding.
- Experience using analytics tools (Spotfire, Tableau, etc.).
- Ability to analyze, interpret, and summarize complex clinical and medical literature data
- Ability to prioritize and complete work in a resourceful, self-sufficient manner while maintaining a strong mentality
- Displays ability to understand established procedures and communicate those procedures to others
- Exhibits comprehension of industry practices and regulations for drug development and pharmacovigilance
- Identify potential gaps in the PV department and develop into project plans.
- Display basic project management skills to drive projects to completion.
- Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, organized, and efficient.
- Must possess excellent interpersonal skills, the ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, and the ability to analyze complex issues to develop relevant and realistic plans, programs, and recommendations.
- Must have a demonstrated ability to translate strategy into action, excellent analytical skills, and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
As an equal opportunity employer, Allogene Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.