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Open Positions: Principal Research Investigator, Formulation R&D

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 two clinical-stage programs: ARV-110, which is being developed as a potential treatment 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 200 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.

Position Summary

The Principal Research Investigator will serve as a core member of discovery and early development teams to identify and execute formulation strategy for Arvinas PROTAC® clinical candidates as they are identified, progress through toxicology studies, and into early clinical evaluation. Working closely with discovery chemistry, analytical, and DMPK resources, the qualified individual will design and execute biopharmaceutical experiments to understand the mechanisms of oral exposure and use the results to design formulations maximizing exposure of BCS II/IV for preclinical/clinical proposes. Subsequently, they will work with development teams to manufacture clinical supplies. To achieve these goals, the Principal Research Investigator will leverage Arvinas’ internal formulation and preformulation capabilities and, as needed, identify, engage, and have technical oversight of external CDMOs. Internally directed activities include researching the relationship between PROTAC physicochemical properties oral absorption processes for the purposes of drug delivery.

Externally facing responsibilities will include preparation of request for proposals, negotiating contracts, and thereafter directing and monitoring the activities of drug product partners.

Enabling delivery of beyond rule-of-five compounds is one of most active areas in formulation research today, opening many novel options for those scientists willing to engage the challenge. Arvinas leads the field of protein degradation – one of the newest areas in pharmaceutical research and development, and one with the potential to have profound impact on human health. The resulting combined problem statement represents a unique opportunity for scientists to establish the future paradigm for molecular design and delivery for this mode of therapeutic intervention.

This position reports to Executive Director, Formulation R&D and will be located at our headquarters in New Haven, CT or may be performed from a remote location within the U.S.

Principal Responsibilities

Key responsibilities of this role include, but are not limited to:

  • Provide technical leadership, expertise, and specialized knowledge in formulation development and biopharmaceutics to support the Arvinas portfolio of drug candidates and early development assets
  • Design and conduct preclinical studies that efficiently identify mechanisms of solubilization and oral absorption; translate the information so gained into clinically viable formulations
  • Maintain a state-of-the-art understanding of formulation/drug-delivery technologies and how they are best applied to enablement of therapeutically viable beyond rule-of-five compounds.
  • Develop fit-for-purpose formulations to appropriate for Phase 1 investigation and enabling preclinical studies (e.g., toxicology)
  • As needed, identify potential CDMOs, prepares requests-for-proposals, and evaluate the vendor response in the context of scientific understanding, technical proficiency, and timing of deliverables
  • Negotiate contracts and directs and monitors the activities of selected formulation development and manufacturing organization(s).
  • Apply scientifically driven thinking to the development of formulations and products which meet pre-determined product profiles.
  • Convert data on formulations into subject matter expert-level content required for IND filings
  • Assume responsibility as subject matter expert and assist in authoring regulatory documents

Qualifications

  • At least 10 years of experience in biopharmaceutics and oral formulation design is required.
  • Demonstrated success in with formulation development of compounds in the that are challenging with respect to solubility, permeability, lipophilicity, and ADME properties.
  • Direct experience applying formulation technologies and strategies for BCS II/IV compounds in lead optimization, candidate selection, preclinical, and manufacturing environments.
  • A clear understanding of the relationship between molecular properties (e.g., solid state characteristics, solubility, supersaturation, etc.) and formulation performance, design, selection, and troubleshooting.
  • Direct hands-on experience with biopharmaceutical tools both in vitro (e.g., non-sink dissolution, flux, etc.) and in silico (e.g., GastroPlus, MAD, etc.)
  • Experience interpreting the exposure profiles of compounds in preclinical in vivo experiments in the context of dissolution, precipitation, precipitation, and colloid formation
  • A willingness to take on challenging problem statements and acquire/apply the skills necessary to address them.
  • Ability to be proactive in identifying issues and hurdles that may hinder the effective implementation and/or progression of a study and resolve the issues in a timely and creative fashion.
  • Ability to effectively prioritize and deliver on tight timelines.
  • Experience in communicating/presenting complex information to scientists from other disciplines.
  • Ability to multi-task and manage several projects in parallel, paying attention to detail.
  • Ability to forge cross-functional working relationships with internal and external project partners.
  • Excellent oral and written communications skills.
  • Experience in using computers and databases for data collection, compilation, analysis, and information dissemination.
  • Ability to establish and maintain effective working relationships.
  • Ability to work in a fast-paced, highly motivated work environment.
  • Entrepreneurial with self-starting personality; ability to prioritize and manage multiple responsibilities simultaneously.
  • Enthusiastic desire to roll up sleeves and dig in. Confidence in own abilities to get things done.
  • Able to meet tight deadlines on multiple priorities.
  • Customer-focused with strong teamwork, interpersonal and communication skills.
  • Requirement to maintain a high level of confidentiality.
  • Ability to develop creative solutions to problems and implement them.

Education

  • PhD or MS in Pharmaceutical / Medicinal / Physical Chemistry

#LI-Remote

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

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