Sr. PV Medical Director/TA Lead - #19528489

EQRx


Date: Feb 23, 2021
City: Cambridge, MA
Contract type: Full time
EQRx

We believe it's possible to have a profound impact on bending the cost curve in healthcare by building a pipeline of innovative medicines and bringing them to market at dramatically lower prices.


Robert Forrester CXO


EQRx believes responsibility can be revolutionary. Want to make a difference while advancing your career? Come join a team that is working towards our bold mission of developing innovative medicines at radically low prices to help people get the medicines they need.


What You'll Do


You will act as the global safety lead for assigned pre- and/or post-marketing compounds. This role will lead the safety activities and benefit-risk strategies for assigned EQRx compound(s)/ programs and chair/co-chair the product SMT(s). You will lead the medical safety oversight of and execution of risk management strategies and RMP elements for assigned products and responses to HA queries. You will ensure ongoing and adequate safety surveillance and timely detection and communication of new safety issues.


You will provide safety input to safety-related documents, including but not limited to clinical development plans, study protocols, amendments, IB, statistical analysis plan (SAP), ICF, CSR, approve safety aggregate reports, product renewal submissions, and post-marketing study documents and reports. You will provide safety lead support for global submission document production, including integrated safety data review, integrated safety summary document review, and safety-focused publication development. This role will oversee, prepare, and review aggregate safety review documents (e.g., DSUR, PBRER) and safety sections of relevant clinical trial documents (e.g., protocols, clinical study report [CSR], investigator brochure [IB], informed consent form [ICF]) and regulatory filings (e.g., clinical trial applications [CTA], marketing authorization applications [MAA]). You will also support the EU QPPV or other regional or local Qualified Person for PV relative to issues relating to assigned products.


As therapeutic area lead for Oncology TA, you will lead the Oncology TA within PV department and recruit and lead a team of physicians and scientists. You will be accountable for benefit-risk assessment, signal detection, and risk management of all products/programs in oncology TA. You will represent Global Drug Safety at internal strategic and advisory/governance committees. You will chair or participates in internal safety review meetings where applicable and also may represent EQRx or act as an external technical resource at DSMB or Regulatory Authority meetings and at external conferences. You will provide Global Drug Safety leadership and contributes to key governance processes. You will be a people manager and will counsel, coach, and develop your team to great heights.


The Impact You Will Have


This is not your standard PV role. This position is highly visible and of significant impact to the company. We are on a critical mission to bring quality solutions to patients at a fraction of the price. This role will help us drive forward towards that pinnacle goal of truly putting patients first.


Your Superpowers


You are an MD.


You have at least 5+ years of extensive relevant pharmaceutical industry experience in the safety and risk management area - including in signal detection, validation, and management.


You have oncology drug safety experience (clinical experience preferred).


You are a results-driven leader who drives teams to foster a proactive solution-oriented to safety signal detection, evaluation, and risk management.


You have a very thorough knowledge and understanding of PV deliverables, standards, and processes at a global level, including pre and post-launch experience.


You have NDA/BLA experience.


You have excellent interpersonal, analytical, managerial, and organizational skills.


You can participate and work effectively on multiple cross-functional teams


You understand relationships are key and have strong interpersonal skills.


You are a leader. Teams love working with you and you are someone who takes pride in mentoring and supporting the careers of others.


You can thrive in a smaller company environment and love the pace of a true startup


You're a team player who is willing to roll-up your sleeves and get the job done.


Are you bold enough?


Your work should matter and allow you the freedom to be 100% you. We spend too much time and effort in our career to not feel excited and proud about what we do and who we do it with. In other words, your career is too important for your next move to be just another job, so let's work together to change the world and bring affordable medicines to all patients.


We aren't about a bunch of empty slogans on a wall or words on a coffee cup – you can find that in lots of places. We are a culture of individuals with diverse backgrounds and personalities. What does EQRx stand for?



  • EQ


uality Medicines: Equally good or better, innovative medicines



  • EQ


uitable Medicines: Making innovative medicines affordable



  • EQ


ual Access: Sustainable, frictionless access for people to cutting-edge medicines


We have a bold mission and are looking for equally bold people who want to join us and help make a difference in the world. If you want to grease the wheel, we are definitely not for you. Want to build the wheel? We might be just what you are looking for.


Apply


Are you bold enough?


Your work should matter and allow you the freedom to be 100% you. We spend too much time and effort in our career to not feel excited and proud about what we do and who we do it with. In other words, your career is too important for your next move to be just another job, so let's work together to change the world and bring affordable medicines to all patients.


We aren't about a bunch of empty slogans on a wall or words on a coffee cup – you can find that in lots of places. We are a culture of individuals with diverse backgrounds and personalities.

How to apply

To apply for this job you need to authorize on our website. If you don't have an account yet, please register.

Post a resume