Open Positions: Senior Director, Modeling and Simulation
Arvinas is a clinical-stage biopharmaceutical company leading the way in targeted protein degradation therapeutics. Arvinas is the first company to focus solely on protein degradation and its platform technology is the most advanced in the field. Since its founding in 2013, Arvinas’ PROTAC® Discovery Engine has been driving the most significant breakthroughs in the industry. Arvinas’ pipeline encompasses a range of validated and undruggable targets in oncology, immuno-oncology, and neuroscience. This includes three clinical-stage programs: bavdegalutamide (ARV-110) and ARV-766, which are being developed as potential treatments for men with late-line metastatic castrate-resistant prostate cancer, and ARV-471, which is being developed as a potential treatment for patients with breast cancer.
#TeamArvinas is made up of more than 350 passionate and curious employees, whose diverse thoughts and perspectives are highly valued. Arvinas employees embrace the freedom to pursue innovation, think creatively, and give back. They are driven by the company’s values and purpose – to improve the well-being of patients and families impacted by the devastating diseases Arvinas is working to treat. It’s an exciting time to be in drug development and it’s an exciting time to be at Arvinas. But don’t just take our word for it – here’s what Arvinas employees are saying. For more information, please visit www.arvinas.com.
The Senior Director of Modeling and Simulation will lead all modeling activities from pre-clinical to clinical development. This person will be tasked to build the modeling and simulation infrastructure for Arvinas. In addition, s/he will provide modeling informed drug development expertise working closely with DMPK and Clinical Pharmacology on Arvinas drug development program teams. This person will be a critical link with internal clinical pharmacology members, CROs, and external subject matter experts. The individual will collaborate with key stakeholders in delivering clinical pharmacology data and interpretations in support of our company’s mission to bring hope and new therapies for patients.
This position reports to our VP, Clinical Pharmacology, DMPK, and Toxicology. This role is based out of our New Haven, CT office or can be performed remotely from a location within the United States.
Key responsibilities include, but are not limited to:
- Develop and implement modeling strategy; design and execute pharmacometic plan and exercise, and accountable for the analysis of pharmacokinetic and pharmacodynamic data from lead-op to phase IV.
- The selected individual will work closely with physicians, scientists, regulatory professionals, statisticians and members of the clinical operations department to carry out these responsibilities.
- Responsible for pharmacometric analysis, report writing and review, using his/her modeling expertise to identify ways to best analyze and present pharmacokinetic and pharmacodynamic data in a complete, accurate and scientifically sound
- Hire and develop talents for modeling and simulation
- Select and work with CRO to complement internal capabilities on advance pharmacokinetic and pharmacodynamic modeling at pre-clinical and clinical study level.
- Lead an intra-department project or initiative involving other contributors by acting independently to determine methods and procedures on new assignments.
- Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
- Works on extremely complex problems in which analysis of situations or data requires an evaluation of intangible variables.
- A minimum of 10+ years related experience clinical drug development experience in industrial, academic, or regulatory settings; may include post-doctoral experience.
- Demonstrated leadership experience building organizational capability (talent, modeling and simulation platform, and infrastructures).
- Expert knowledge of pharmacometric principles and concepts in achieving objectives in creative and effective ways.
- Demonstrated success in technical proficiency, scientific creativity, collaboration with others and independent thought.
- Experience in implementing pharmacometrics analysis and reporting to health authority.
- Good oral and written communication skills for effectively interfacing with internal and external collaborators.
- Track records of applying advance pharmacokinetic and pharmacodynamic modeling software such as ADAPT, Mathlab, NLME, NONMEM, Gastroplus or Simcyp to support program decision is highly desirable.
- Doctor of Pharmacy (Pharm.D), Doctor of Pharmaceutical Sciences (PhD), Doctor of Medicine degree (MD) in Clinical Pharmacology or equivalent, MD/PhD pre
Arvinas is proud to offer a competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, and much more. To learn more about Arvinas, please visit www.arvinas.com
Arvinas is an Equal Opportunity employer