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 Clinical Pharmacologist will serve as the lead clinical pharmacology representative on Arvinas drug development program teams. This person will be a critical link with internal program team members, and external subject matter experts including but not limited to, investigators, key opinion leaders in the external Clinical Pharmacology community and regulatory authorities. The individual will work closely with key stakeholders in developing clinical pharmacology strategy and designing clinical pharmacology studies in support of our company’s mission to bring hope and new therapies for patients.
This position reports to our Executive Director, Clinical Pharmacology. 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 of this role include, but are not limited to:
- Serve as the lead clinical pharmacology representative on Arvinas drug development program teams.
- Collaborate with subject matter experts in Clinical Research, DMPK, Regulatory, CMC, Toxicology, Pharmacology to progress clinical compounds from preclinical through all phases of clinical development, in a program team.
- Provide input into identifying appropriate clinical pharmacology investigators/CROs for these studies.
- Develop and implement clinical pharmacology strategy; design and execute clinical Pharmacology studies, and accountable for the analysis of pharmacokinetics and pharmacodynamics.
- The selected individual will work closely with physicians, scientists, regulatory professionals, statisticians and members of the clinical operations department to carry out these responsibilities..
- The individual will respond to inquiries by practitioners and investigators, IRBs, regulatory bodies, and vendors on Clinical Pharmacology related questions. This person will work to establish relationships with key Clinical Pharmacology opinion leaders, external Clinical Pharmacology advisors and collaborators.
- Responsible for clinical pharmacology and clinical research report writing and review, using clinical pharmacology expertise to identify ways to best analyze and present pharmacokinetic and pharmacodynamic data in a complete, accurate and scientifically sound.
- Publish, evaluate and assess clinical pharmacology publications (abstracts, posters, manuscripts).
- Responsible for clinical pharmacology- regulatory related activities for submissions including IND and/or NDAs.
- Establish work processes & procedures for the clinical pharmacology department.
- A minimum of 10+ years of clinical drug development experience in industrial, academic, or regulatory settings; successful in implementing clinical pharmacology studies; track records of high impact publications and/or presentations at premier clinical pharmacology meetings; track records of successful delivering clinical pharmacology-responsible regulatory submissions such as the IND or NDAs, and with other global regulatory agencies such as EMA, PMDA or TGA.
- People management experience and/ or experience with mentoring.
- Experience in at least one of the following therapeutic areas: medical oncology, hematology, immunology, and/or CNS.
- Excellent oral and written communication skills for effectively interfacing with internal and external collaborators.
- Proficient in integrating model-informed drug development approach to enhance program team decisions.
- Track records of applying advance pharmacokinetic and pharmacodynamic modeling software such as NLME, NONMEM, Gastroplus or Simcyp to support program decision is highly desirable.
- Hands-on experience with data cleaning and data transformation with programming or software programs (e.g. R, spotfire) would be preferred.
- Bioanalytical exposure would be a plus.
- 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