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Associate Director, Clinical Outsourcing

4 months ago

New Haven, United States Arvinas Full time

Arvinas is a clinical-stage biotechnology 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 three investigational clinical-stage programs: ARV-766 and bavdegalutamide for the treatment of men with metastatic castration-resistant prostate cancer; and vepdegestrant (ARV-471) for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. Arvinas, as part of its overall business strategy, selectively assesses opportunities for potential collaboration, license, marketing and royalty arrangements, and similar transactions, to advance and accelerate the development and enhance the commercial potential of its product candidates.

#TeamArvinas is made up of approximately 450 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 mission - to improve the lives of patients with serious diseases by pioneering therapies created with our revolutionary PROTAC® protein degradation platform. We're really excited about the work we're doing inside and outside of Arvinas, and think you will be, too. But don't just take our word for it - learn more about life at Arvinas and what employees have to say.

For more information, please visit www.arvinas.com.

Position Summary

This Associate Director is an Outsourcing leader who assists and develops processes, systems, and strategy associated with outsourcing to vendors. The key position will provide support to senior Outsourcing management to actively drive Outsourcing processes and support of internal business owners. This individual will assist and train internal staff to develop and improve department skills and processes. This position reports to the Senior Director of Outsourcing and can be located at our headquarters in New Haven, CT or work remotely from a location within the United States.

Principal Responsibilities

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

  • Supports Clinical, Clinical Pharmacology, and Nonclinical outsourcing requirements.
  • Assists and/or manages Requests for Proposals (RFPs) in support of outsourcing objectives.
  • Mentors and trains Outsourcing staff.
  • Reviews and evaluate vendor budgets performing comparison and analysis functions.
  • Develops and reviews Statements of Work (SOWs) to meeting necessary scope and quality requirements and to ensure optimal contractual terms and conditions.
  • Assists with the coordination of vendor identification, selection, governance, and oversight.
  • Ensure contracts, budgets, change orders, etc. have been uploaded to Arvinas folders and disseminated to the appropriate parties.
  • May assist with resolving invoicing issues as needed.
  • Helps track vendor projects to generate outsourcing metrics and KPIs as required.
  • Assists with maintaining and updating financial planning and forecasting tools, files, and systems including the use of software tools such as ClearTrials.
  • Participates in study team meetings and vendor meetings as needed.
  • Assists with the development and improvement of templates including RFPs, Project Contracts, Master Services Agreements, as well as financial tracking and invoicing format/tools.
  • Attends and participates in clinical team meetings to review vendor performance and update project specifications in association with ongoing contractual management and invoice approval process.
  • Assists with the tracking on study/project budgets i.e., budgeted vs actual.
  • Ensures Purchase Orders are approved and aligned with each contract.
  • Assists with the execution of the business' sourcing strategy across all functions involved in execution of the company's development strategy.
  • Assists or develops efficient processes for vendor relationship and management of company' major clinical service providers as needed or requested.
  • Assists with driving outsourcing activities by interfacing with operational teams, support groups and service providers for successful selection, contracting and execution of outsourced studies while ensuring compliance with regulatory standards, ethical practices, company's outsourcing and procurement policies and procedures.
  • Serves a process leader and subject matter expert related to outsourcing processes and supports the Senior Director in achieving Outsourcing goals and objectives.
  • Provides operational expertise and strategic leadership, support, guidance, and training to clinical teams on all aspects of outsourced work.
Qualifications
  • 8+ years of Clinical outsourcing experience within the pharmaceutical/biotech industry
  • Advance knowledge of contract research costing, ability to analyze written proposal and cost models.
  • Strong organizational and communication skills.
  • Strong negotiation skills with ability to analyze and assess specific situations/issues.
  • Knowledge and understanding relating to budget impacts of various changes in study parameters.
  • Strong spreadsheet skills, knowledge or contract language and understanding of the industry.
  • Experience building/maintain budgets/forecasts.
  • Experience interacting with a wide range of suppliers, initiating, negotiating and executing financial terms in the clinical trials environment- biotech or pharmaceutical industry.
  • Experience managing RFPs and summarizing bids for presentation to teams & management for consideration.
  • Specific experience in negotiating Discounts/Rebates reviewing vendor rate cards.
  • Experience in reviewing PI Site budgets is a plus.
  • Experience with creating/processing Purchase Orders including Change Orders associated workflows and approvals.
  • Proven experience in managing key internal and external stakeholders effectively.
  • Proven time management skills and ability to be flexible to meet job demands and take on new initiatives and improvement efforts.
  • Detail focus and ability to sustain high levels of performance in a constantly changing environment.
  • Knowledge of GCP, Sunshine Act, GDPR, and other industry standards.
Education
  • Bachelor's degree in Business Administration, Finance, Life Sciences or Pharmacy. Advanced degree preferred.


#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