Reimagine the infrastructure of cancer care within a community that values integrity, inspires growth, and is uniquely positioned to create a more modern, connected oncology ecosystem. We're looking for a Medical Director of Patient Safety and Pharmacovigilance to help us accomplish our mission to improve and extend lives by learning from the experience of every person with cancer. Are you ready to be the next changemaker in cancer care?

What You'll Do

In this role reporting to the Head of Research Oncology, Clinical Research, you'll work with Flatiron's research teams to provide clinical leadership and safety oversight, ensuring quality and translating research into insights that benefit cancer patients.

Your focus will be to apply your biopharmaceutical scientific, managerial and operational training and expertise to the tech-enabled clinical research products, services and trials that Flatiron offers. You will play the critical role in execution and growth of our patient safety and pharmacovigilance (PV) function to ensure the quality of safety oversight and analyses are in line with industry PV standards, evolving PV regulations and legislation. You will be seen as a thought leader, scientist, collaborator and teacher to cross-functional internal teams as well as to our partners. In addition, you'll:

Provide medical and scientific safety support to clinical trials, including:

Safety monitoring
Signal detection and evaluation
Protocol and Informed Consent Form (ICF) design
Safety endpoints in the Statistical Analysis Plan (SAP)
Set-up of safety analyses in prospective real world and clinical trial databases

Ensure compliance with all applicable US and foreign legal and regulatory requirements for adverse event reporting, safety management and pharmacovigilance for Flatiron Clinical Research, including:

Safety issue management
Establishment of and adherence to Safety Monitoring Plans
Assessment and oversight of activities for monitoring adverse event reports for potential safety related issues and provision of recommendations when issues are identified

Hold primary responsibility for safety oversight and compliance, including Contract Research Organization (CRO) management, as required
Review, update or write company SOPs related to Pharmacovigilance and safety reporting to ensure compliance with US and global regulatory guidelines
Provide internal and external guidance through the development of new trainings, processes and products as it relates to the management and interpretation of safety data in prospective real world studies
Assist Clinical Data with MedDRA and WHO dictionary codes and and ensure quality and accuracy of study generated safety data
Monitor PV literature for trends in real world event monitoring, characterization and management recommendations
Collaborate cross-functionally and with key internal and external stakeholders, including regulatory agencies, alliance partners, Key Opinion Leaders (KOLs), and senior management

Who You Are

You're a kind, passionate and collaborative problem-solver who values the opportunity to think beyond the way things are. In addition you're a seasoned professional with at least 4-7 years of Drug Safety/Pharmacovigilance biopharmaceutical experience.You have experience and keen interest in working cross functionally with clinicians, clinical operations and data management professionals, regulatory experts, engineers and other technical experts to apply and adapt pharmacovigilance functions in the real-world setting.

You are an M.D., Ph.D., PharmD or equivalent
You have experience as a Senior Associate Director or Director of PV/Patient Safety for a bio-pharmaceutical/pharmaceutical company or CRO, or an equivalent role in a large pharmaceutical company in support of the therapeutic area/business unit
You have a thorough understanding of the cross functional drug development processes and context applicable to safety surveillance activities required.
Knowledge of MedDRA terminology and its application required
You possess an understanding of current global safety regulatory reporting requirements for investigational and marketed products
You have outstanding communication and presentation skills
You have experience mentoring all levels of staff to further develop skills, provide opportunities for growth, and ensure a professionally challenging environment that fosters retention
You have experience with evaluation, implementation and oversight of pharmacovigilance systems and processes, including developing quality and compliance metrics
You are effective at driving collaboration, achieving results, influencing, and resolving conflicts across internal and external project teams
You have the ability to manage multiple projects simultaneously in a fast-paced environment
You can easily explain scientific and clinical safety concepts to a non-medical, highly sophisticated audience, and have a willingness to teach and learn

Extra Credit

You have experience in clinical development
You have experience in oncology
You have experience with PV audit processes with active participation in Regulatory Authority Inspections

Where you'll work

In this remote position, you have the freedom to choose your preferred work location while aligning your working hours with your team's. For further details on our hybrid work approach and remote work type, please visit the how we work website.

Life at Flatiron

At Flatiron Health, we offer a full range of benefits to support you and your loved ones so you can focus your working hours on improving cancer care and accelerating cancer research, and your non-working hours on everything else life has to offer:

Work/life autonomy via flexible work hours and flexible paid time off
Comprehensive compensation package
401(k) contribution to help you reach your retirement planning goals
Financial health resources including 1:1 financial advice
Mental well-being tools and services
Parental benefits and policies including family-building care and generous leave
Path to parenthood programs supporting fertility, adoption and surrogacy
Travel support for safe healthcare services
Lifestyle spending account for perks that make sense for you and your family

In addition to our robust benefit offerings, visit our Life at Flatiron page to learn how we support continuous learning through professional development programs and celebrate Diversity in the workplace

Job Compensation Range

Preferred Primary Location: NYC Headquarters

Salary Range: $140,000.00 - $255,000.00

An important note on salary

The annual pay range for this position is based on the preferred primary location of the role which is listed above.If you are applying to this role at a location that is not the preferred primary location, please keep in mind the salary range will vary and may fall outside of what is listed. Base pay offered may vary depending on job-related knowledge, skills, and experience. An annual bonus and equity may be provided as part of the compensation package, in addition to a full range of medical, financial, and/or other benefits, depending on the position offered.