Open Positions: Associate Director Project Manager, CMC, Quality
Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC® Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body’s own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. In addition to its robust preclinical pipeline of PROTAC® protein degraders against validated and “undruggable” targets, the company has two clinical-stage programs: ARV-110 for the treatment of men with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. For more information, visit www.arvinas.com.
The Associate Director Project Manager, CMC, Quality will provide critical support in driving key portfolio activities across CMC and Quality. The incumbent will partner with the CMC and Quality Team to shape the overall strategy and ensure successful execution of early to late-stage programs in the portfolio. The Associate Director Project Manager, CMC, Quality must be agile and adapt his/her thinking or approach as the situation changes in a dynamic, fast-paced environment. The incumbent will represent the CMC team position at key planning and cross functional meetings and will maintain and manage the integrated development plan for CMC and quality activities.
This position reports to Executive Director, Enterprise Project Management and can be Remote or based in New Haven, CT.
Key responsibilities of this role include, but are not limited to:
- Establish strong partnership with CMC Team Leader to shape the overall strategy and ensure successful execution of early to late- stage programs in the portfolio.
- Manage internal and external cross functional team meetings (vendor related interactions) and drive execution of program strategy by fostering communication and integration of all functional area representatives on the integrated development team.
- Create and manage all integrated CMC meeting logistics including the meeting minutes that are shared as appropriate to align all functional representatives of decisions and actions agreed upon by the team.
- Responsible for the development of a detailed CMC project plan that is aligned with the overall program strategy. Tracks all project milestones and clearly communicates status of project leveraging established tools.
- Leverages portfolio and program management tools to track program execution, milestones, risks, and long-range planning to ensure appropriate communication to team members within CMC and broader development and strategic operations organization.
- Support the integration of key Quality driven activities into the CMC and overall clinical development plan.
- Facilitate cross functional team discussions related to Quality deliverables supporting CMC, Regulatory, Clinical operations and or other functions.
- Represent the CMC and Quality teams in certain governance interactions, as appropriate.
- Member of the Project management organization and support the development of key processes, tools and approaches. Lead continuous improvement or key strategic projects as appropriate.
- Develops and maintains integrated program budget and forecasts in collaboration with Asset Team leaders, Cross-functional team members and Finance
- Ability to conduct process analysis and develop and implement plans
- Ensure effective communication with external stakeholders and collaborative partners
- Drug development knowledge with basic to strong understanding of other functions relevant to the position which may include: research, toxicology, clinical pharmacology, clinical, manufacturing, and regulatory.
- Must be able to work independently and collaboratively in a fast-paced, matrixed, team environment consisting of internal and external team members.
- Superior communication and interpersonal skills; effective interaction with cross functional team members.
- Experienced in managing multiple initiatives while working in a fast paced and dynamic environment.
- Demonstrated planning, organization and time management skills including the ability to support and prioritize multiple projects.
- Ability to adapt quickly to changing priorities
- Excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Highly motivated, self-starter able to work with minimal supervision and direction
- Excellent attention to detail
- Skilled in managing multi-disciplinary teams both internally and externally
- Proficiency with Project Management related and Microsoft Office Software Programs.
- Bachelor’s degree in Life Sciences or Pharmacy or higher.
- 10+ years in the pharmaceutical industry in roles associated with drug development
- 5+ years supporting cross-functional CMC, Quality and relevant development team activities
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.