- Our Pharmaceutical Drug Development team is growing. We’ve been thrilled to welcome new teammates across DMPK, Drug Substance and Toxicology as our team has multiplied! As a senior leader among this team, and reporting to the head of this group, you’ll provide strategic input into leading all phases of clinical development. Come aboard as we build our Pharmaceutical Development function.
- We’ll look to you to serve as the clinical pharmacology lead on clinical development teams, providing strategic leadership and execution of clinical development plans that include characterization and prediction of the pharmacokinetics, pharmacodynamics and drug metabolism of the drug candidate in selected clinical areas.
- You will also provide rationale for dose regimen selection, safety margin assessment and identification of circumstances where dose adjustment or patient selection/stratification should be considered.
- You will leverage your experience with writing/reviewing the clinical pharmacology sections for IND/NDA/CTA/ MAA submissions.
- You will lead protocol design, study planning, review, data analysis / interpretation, and reporting of individual studies implemented to support clinical pharmacology components of project plans.
- You will be responsible for planning, preparing and reviewing drug development plans and regulatory filings. This includes determining scope, design, planning and analysis of phase 1-4 pharmacokinetic and pharmacodynamic studies, investigations, and modeling/simulations required from a development and regulatory perspective to take a project from its existing or concept stage to commercialization. Responsibilities include describing results of these studies in various regulatory documents (IND’s, NDA’s, IB’s, etc.)
- You’re a natural collaborator as you will work cross functionally with early development colleagues on the scientific aspects of assigned studies from conception through final report, including protocol development, budgeting (as appropriate), timelines, sample handling/processing, bioanalysis (through CRO), and clinical PK data analysis.
- We’ll look to you to manage vendors supporting clinical pharmacology studies and analyses in order to establish proof of principle.
- You will represent Relay Tx in interactions with regulatory agencies and responding to regulatory inquires related to clinical PK, PKPD, and clinical pharmacology.
- Be prepared to flex your modeling skills! You will be responsible for ensuring/performing appropriate PK/PD analysis including population PK, PK/PD modeling and simulation, meta-analysis, mechanistic modelling, disease state modelling as required by the program to aid in data interpretation, trial design and/or program decision-making.
- You will participate in writing publications and making scientific presentations consistent with development strategies and publication plan.
- We will also depend on you to stay up to date on the latest scientific and regulatory practices, guidance and trends, and ensure that the clinical pharmacology aspects of development programs are contemporary.
- Last but not least by any means, as a senior leader in your function, we’ll depend on you to help us continue to build an energetic, collaborative and open company culture and contributing to the company’s success
- You earned your PhD in pharmaceutical sciences, pharmacokinetics, pharmacometrics, Pharm D or related field.
- You bring at least 15 years of biotechnology or pharmaceutical industry experience including clinical pharmacology studies, PK/PD modeling, QSP, drug development, protocol/IB preparation support, regulatory interactions and IND/NDA submissions.
- You have strong quantitative, hands-on skills in modeling and simulation across a range of modeling techniques (e.g., PKPD, PBPK, systems modeling, mechanistic modeling, population and ER analysis).
- If you've been known to work with Win-nonlin/Phoenix NLME, SYMCYP, NONMEM, GastroPlus etc., we seriously want to talk to you.
- Your former DMPK colleagues would consider you a partner, as you’ve spent time with them to ensure appropriate clinical pharmacology strategy is developed together.
- You understand database designs and desired outputs needed for reliable pharmaco-statistical analysis and other reporting-related activities.
- When it comes to writing, you’re at ease with creating high quality written reports and summary documents for use in regulatory submissions.
- You have strong communication skills, can flex to different work styles, and believe that the best outcomes result from leveraging the strengths of your team members.
- No stranger to the land of NDAs, you have successfully prepared many regulatory documents from IND through NDA.
We believe in building balanced teams and a place where our people can be their full self every day. We encourage people from underrepresented backgrounds to apply.
Relay Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
At Relay, we believe that along with our people, our culture is our greatest asset. In fact we're proud to share we were named as one of the Boston Business Journal's “Best Places to Work“ in 2017, the #1 place for small companies in 2018 & the #2 place for small companies in 2019. To drive that culture, no one will stop you or hold you back. Instead, we will give you the tools and colleagues to push forward relentlessly and cheer you on as you go. If this resonates with you, drop us a line.
About Relay Therapeutics
Relay Therapeutics is a new breed of company at the intersection of computation and biotechnology that is committed to creating medicines that will have a transformative impact on patients.
We combine unprecedented computational power with leading-edge experimental approaches across the fields of structural biology, biophysics, chemistry, and biology. This integration illuminates – for the first time – the full mobility of a protein and provides key insights into how the dynamic nature of a protein’s conformation regulates function. The team at Relay is putting this principle into practice, with the aim of accelerating the development of medicines that will make a transformative difference in patients’ lives. We don't just stare hard problems in the face. We go out looking for them. Are you energized by attempting to do the impossible? We're looking for you.
At Relay, our team is driven by the ultimate collaboration across each of our drug discovery disciplines. Putting protein motion at the heart of drug discovery is a challenge, but we are confident that our team’s dedication and urgency will create opportunities that deeply impact the lives of the patients. Our initial programs are focused on developing therapeutics in oncology.
Relay Therapeutics is a private company launched in 2016 with financing from Third Rock Ventures and an affiliate of D. E. Shaw Research. To date the company has raised $520M from investors including Third Rock Ventures, SoftBank Vision Fund, GV, Casdin Capital, BVF Partners, EcoR1 Capital, Foresite Capital, Perceptive Advisors, Tavistock Group and an affiliate of D.E. Shaw Research.