Seagen

Senior Manager Clinical Contracts

Development Madrid, Spain

Description

Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us!

Summary

The Sr. Manager, Clinical Contracts is responsible for leading the clinical study contracts team, supporting Seagen, Inc. sponsored clinical trials by providing management and oversight of the clinical study contracts process, including the flow of clinical trial agreement lifecycles, negotiating clinical site budgets, conducting business operations as detailed below, and for ensuring that study deliverables are completed on time, with a high degree of quality, and in accordance with corporate and regulatory requirements. This position will work closely with stakeholders such as clinical study teams, study start up teams, clinical project managers, the Legal department, and clinical study site personnel.

Principal Responsibilities:

• Lead and provide oversight for the clinical contract, Master Clinical Trial Agreements (MCTA), Non-Disclosure Agreements (NDA), and vendor contract processes.
• Manage the study site budget process from initial template stage to fully negotiated site contracts and amendments.
• Analyze site contract trends and develop metrics. Benchmark against industry standards and establish target goals.
• Manage study and resource assignment within the Clinical Contracts team.
• Work with stakeholders to identify, evaluate, and implement opportunities to improve processes.
• Manage clinical contracts status reporting to study teams.
• Conduct daily oversight of contract tracking, contract quality control, and remediate as needed.
• Adjudicate contracts fall back language and manage escalations.
• Ensure consistency in site payment schedules and terms.
• Serve as clinical contract liaison with the Legal group, Seagen study teams, Contract Research Organizations (CROs) and Site Management Organizations (SMOs).
• Provide oversight on CRO contracting services and manage CRO and vendor performance using metrics and KPIs.
• Work collaboratively with the clinical study teams to ensure Clinical Contract deliverables are identified, communicated appropriately, and met.
• Collaborate with Seagen Study Start Up team to facilitate contract execution as required for site initiation visit and site activation.
• Maintain the clinical finance database with site and vendor contract budget data.
• Support maintenance of the Legal contract database.

People Management:

• Set goals and provide oversight, guidance, mentoring, feed-back and performance reviews.
• Manage team workload efficiently across studies to ensure deliverables are met.
• Perform hiring, onboarding, and training activities as needed.
• Provide status updates to management and stakeholders.
• Develop and maintain process documents and tools.
• Adhere to department standards and guidelines.
• Ensure compliance with regulatory requirements.
• Special projects as required.

Required Qualifications:

• Bachelor’s degree in Business Administration, Life Sciences, Law or Accounting (Master’s degree Preferred).
• Minimum of seven (7) years of experience working in Contract Management in the Pharmaceutical Industry, biotech or CRO, finance and/or legal environment.
• Minimum of seven (7) years experience negotiating contracts and budget, adjudicating contracts fall back language and managing escalations.
• Intermediate Excel and database management skills.
• Knowledge of CFR and GCP/ICH requirements.
• Requires effective problem solving, organizational and communication skills.
• Must have good customer relations skills and a strong team player.

Preferred Qualifications:

• Master’s degree in Business Administration, Life Sciences, Law or Accounting.
• Nine (9) years of experience working in Contract Management in the Pharmaceutical Industry, biotech or CRO, finance and/or legal environment.
• Nine (9) years experience negotiating contracts and budget, adjudicating contracts fall back language and managing escalations.

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 04/22/2022