At Genmab we are dedicated to building extranotordinary futures together by developing antibody products and groundbreaking knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases. We strive to create champion and maintain a global workplace where individuals unique contributions are valued and drive innovative solutions to meet the needs of our patients care partners families and employees.
Our people are compassionate candid and purposeful and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes our work is incredibly serious and impactful but we have big ambitions bring a ton of care to pursuing them and have a lot of fun while doing so.
Does this inspire you and feel like a fit Then we would love to have you join us!
The Sr. Manager leads the end-to-end management of Clinical Trial Agreements (CTAs) Fair Market Value (FMV) negotiations and payment processes. As the primary contact for clinical trial sites the role ensures our site contracts meet legal and regulatory requirements real-time metrics and proper document management. The position requires strong communication and follow-up skills that directly contribute to faster study start-up timelines and smooth trial execution.
Key Accountabilities (including but not limited to)
End-to-End Site Contract Management
Lead and oversee the full lifecycle of Clinical Trial Agreements (CTAs) including drafting reviewing negotiating FMV executing and maintaining contracts. Implement when possible Master Clinical Trial
(MCTAs) and support CTA amendments (as applicable).
Primary Contact for Contract Execution
Act as the central point within Genmab and our sites
for all matters related to CTA execution storage and management.
Legal and Regulatory Compliance
Ensure all CTAs and final site budgets remain in alignment with current legal regulatory and compliance requirements. Collaborate with Legal and Compliance teams to integrate evolving requirements into contracts.
Documentation and Record Management
Maintain complete accurate and inspection-ready documentation of all site contracts correspondence and approvals in accordance with internal- and regulatory requirements as well as audit/inspection expectations. Ensure timely updates and version control across documentation systems.
Stakeholder Communication & Reporting
Partner with internal stakeholders to ensure transparency. Provide clear and timely updates on site contract status to the clinical trial team. Proactively contributes to trial-related meetings ensuring alignment on contract progress risks and timelines.
Inspection Readiness & Trial Support
Support the core trial team in ensuring all site-level documentation and contracts are audit- and inspection-ready. Contribute to risk mitigation and resolution of issues impacting trial timelines or site engagement.
Qualifications/Experience
(preferred professional experience level)
7 years of experience in relevant operations and/or R&D functions the biotechnology/ pharmaceutical CRO or healthcare industry
Bachelors degree
Strong expertise in Contract negotiation and site financial agreements
Substantial Experience in reviewing and negotiating relevant agreements
Familiarity with GCP ICH and relevant FDA/EMA guidelines from a financial perspective
Demonstrated ability to collaborate across functional teams and communicate effectively with clinical and financial stakeholders
Excellent verbal/written communication and negotiating skills
Demonstrate advanced skills in Microsoft Office applications (Excel Word PowerPoint Outlook) Saas based platform tools and other industry standard programs
Attributes of a successful candidate
Self-starter; motivated by working in a fast-paced ambiguous environment
Detail oriented timeline driven and ability to work in a structured environment as an individual and team contributor
About You
You are genuinely passionate about our purpose
You bring precision and excellence to all that you do
You believe in our rooted-in-science approach to problem-solving
You are a generous collaborator who can work in teams with a broad spectrum of backgrounds
You take pride in enabling the best work of others on the team
You can grapple with the unknown and be innovative
You have experience working in a fast-growing dynamic company (or a strong desire to)
You work hard and are not afraid to have a little fun while you do so!
Locations
Genmab maximizes the efficiency of an agile working environment when possible for the betterment of employee work-life balance. Our offices are crafted as open community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether youre in one of our office spaces or working remotely we thrive on connecting with each other to innovate.
About Genmab
Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years its hard-working innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational quantitative and data sciences resulting in a proprietary pipeline including bispecific T-cell engagers antibody-drug conjugates next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030 Genmabs vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO) antibody medicines.
Established in 1999 Genmab is headquartered in Copenhagen Denmark with international presence across North America Europe and Asia Pacific. For more information please visit and follow us on LinkedIn and X.
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Required Experience:
Manager
Founded in 1999, we are an international biotech company committed to improving the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, our passionate, innovative and collaborative team has invented next-generation antibody technology platforms ... View more