Manager, Clinical Contracts and Outsourcing

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.

Zymeworks is seeking a highly motivated Manger, Clinical Contracts and Outsourcing 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.

• Provides support and expertise in developing effective clinical contractual agreements, budgets,
proposals and actively manage clinical contractual obligations working closely with clinical finance and clinical study teams.
• Negotiates final scope of work, budget, and payment schedules with input from cross-functional
stakeholders for clinical study service providers.
• Negotiate change orders and ensures service providers adhere to contract terms.
• Generates Request for Information (RFIs), Request for Proposal (RFPs) and budget grids/trackers
for clinical trials and assist Clinical Operations Management with the service provider selection
process including bid comparison analysis working closely with clinical finance team.
• Coordinates bid defenses and proposal review meetings.
• Contract lifecycle management.
• Assists Clinical Operations and Finance with month-end accrual and budget/forecasting needs,
such as reporting site-level and study-level cost-per-patient data.
• Assists Clinical Operations team with creating and overseeing global clinical trial site budgets.
• Will be the primary Clinical Operations contact/liaison to work with Zymeworks legal, finance and CROs across multiple clinical programs to manage clinical site contracts and budgets.
• Supports the day-to-day activities of multiple areas in complex clinical contracting processes.
• Embody and champion Zymeworks’ values: Innovate. 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.
• Solid understanding of clinical trials and clinical operations.
• Ability to negotiate external provider work/change orders, clinical site budgets, etc. and track for clinical operations.
• Must demonstrate an understanding of clinical site and vendor budget and payment terms.
• Experience in RFI/RFP development, proposal evaluation, and contract and budget management.
• 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.

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.