Manager, Clinical Site Contracts and Budgets

Clinical Development United States


Description

Why Work for Us?

Innovation. Act with Integrity. Collaboration. Embrace Diversity. Care 

We come from many countries, cultures, races, ethnicities, abilities and nationalities. We bring our passions including singing, biking, swimming, dancing, cooking, volunteering, parenting, coaching and much more! We are proud of our nearly equal balance of men and women and strengthened by our non-binary and transgender team members. Every employee belongs. 

We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance. 

Company Description  

Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation bispecific and multifunctional biotherapeutics, initially focused on the treatment of cancer.  Zymeworks’ suite of complementary therapeutic platforms and its fully-integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly-differentiated product candidates.

About the Position

Zymeworks is seeking a highly motivated Manger, Clinical Site Contracts and Budgets who is looking to grow their career with our company.

This position will report to the VP, Clinical Operations and can be in either Seattle, WA, Vancouver, BC, or remote US.

Job Description and Responsibilities

The Manager, Clinical site Contracts & budgets is responsible for developing and negotiating clinical trial budgets and managing clinical trial agreements (CTA) development timelines for global Phase 1 through IV clinical studies and management of Clinical Research Organization (CRO) involved in contracting process. Manager, Clinical Site Contracts & Budgets reports to the head of Clinical Operations.

  • Partners with Clinical Operations, R & D Finance and Clinical Research Organization (CRO) to develop study specific budget templates and negotiation parameters for global Phase I-IV clinical studies.

  • Partners with Clinical Operations and Legal to develop site contracting timelines with CROs, tracks progress and provides regular updates to internal partners and study teams.

  • Will provide oversight of contract activities for multiple clinical development programs ensuring contracts are accurate, consistent, and executed in a timely manner.

  • Responds and resolves complex issues associated with domestic and international contracts working closely with CRO and Zymeworks legal department.

  • Coordinates with CROs, Zymeworks Clinical Operations, Legal and R & D finance to manage and complete the site contracts process throughout the studies

  • This role can manage the day-today activities in complex clinical trials contracts (CTA) and budget negotiation processes.

  • Evaluates contract and budget changes requested within CTA and identifies business and/or legal risks, manage the issues to resolution. Escalates issues for approval, as required.

  • Ensures compliance of contracts with Fair Market Value (FMV) principles and guidelines.
  • May support the development and maintenance of guidelines, training programs, policies and procedures related to clinical trial contracts and budgets.

  • Develop Contract Guidance Plans with CROs.

  • Leads the Contract lifecycle management process for clinical studies.

  • Embody and champion Zymeworks’ values: Act with Integrity. Collaborate. Care.

Qualifications

  • Required BA/BS in related discipline, a combination of relevant education and applicable job experience may be considered

  • 5 years of related experience in biotech or pharmaceutical organization

  • Experience with US and global site budgets required.

  • Experience with complex trial designs preferred

  • In-depth knowledge of negotiations of clinical trial budgets, and an understanding of the drug development process and cross-functional responsibilities.

  • Excellent organization and time management skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively.

  • Excellent computer skills including advanced knowledge in MS Excel, MS office

  • Must be self-starter who works with minimal supervision

  • Good business judgement and a strong understanding of the unique aspects of clinical financials

  • Must have the ability to interact with clinical teams, corporate finance and clinical development cross functional team

  • High sense of accountability/urgency

  • Adhere to the highest degree of professional standards and strict confidentiality on matters that require discretion.

Additional Information

10% or less domestic travel may be required in this role.

NOTE TO EMPLOYMENT AGENCIES: Zymeworks values our relationships with our Recruitment Partners. We will only accept resumes from those partners whom have been contracted by a member of our Human Resources team to collaborate with us. Zymeworks is not responsible for any fees related to resumes that are unsolicited or are received without contract.