Associate Director, Global Trial Lead

At Genmab, we are dedicated to building extra[not]ordinary® 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!

TOverview

The Global Trial Lead (GTL) is accountable for the end-to-end delivery of one or more clinical trials, from initial strategy to Clinical Study Report (CSR) completion. This includes leading cross-functional Clinical Trial Teams (CTT), managing budgets, and leveraging matrix leadership to align internal and external stakeholders in achieving trial goals efficiently and to high-quality standards. The GCTM serves as the main coordinator for the Trial Team and may take on Clinical Trial Manager (CTM) responsibilities if no CTM is assigned.



Roles & Responsibilities

Trial Leadership and Management

• Lead the cross functional Clinical Trial Team (CTT) including roles such as Medical, Biostatistics, Programming, and Data Management.
• Lead the operational Trial Team, including roles such as Start-up Specialists, Clinical Trial Associates (CTA), and Clinical Trial Managers (CTM).
• Manages CTT resources/membership, assign tasks, and ensure deadlines are met.
• Make tactical decisions within scope to ensure that CTT work aligns with program objectives.
• Define and manage CTT goals in collaboration with team members.
• Provide regular updates, reports, and escalations to the DOPL regarding progress, challenges, risks, and resource needs.
• Review and approve key trial documents, including protocols, amendments, plans, and manuals.
• Oversee vendor selection and manage trial-related contracts and amendments.
• Drive country selection and coordinate responses to IEC/IRB comments.
• Maintain trial integrity by ensuring protocol adherence and addressing data trends.
• Collaborate with the Development Operations Program Lead (DOPL) on cross-functional clinical development team activities and escalate issues as needed.
• Execute strategies for drug supply, regulatory submissions, and patient recruitment.

Budget and Planning

• Assist in the development and management of the trial budget.
• Plan and maintain integrated trial timelines from study outline through CSR.
• Develop recruitment projections and approve adjustments as needed with the Project Lead.
• Act as counterpart to the CRO Project Lead/Manager.

Risk Management

• Identify and manage trial risks with the CTT.
• Oversee maintenance of CTT issue, action and decision logs.
• Assist in audit preparation and ensure corrective and preventive actions (CAPAs) are implemented.

• Act as Subject Matter Expert (SME) for processes within Clinical Operations

The proposed gross annual base salary range for this position, in the primary location, based on a full time schedule is:
GBP79,200.00---118,800.00

The final salary offer will depend on several factors, including your skills, qualifications, and experience.

In addition to base salary, this position is eligible to additional forms of compensation, such as discretionary bonuses and long-term incentives.

When you join Genmab, you become a part of a culture that supports your physical, financial, social, and emotional well-being. Our benefits include, but are not limited to:

• Pension
• Health insurance and wellness benefits
• Paid time off
• Employee support programs

Further details on compensation and benefits will be provided during the recruitment process.

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, Genmab's 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 Genmab.com and follow us on LinkedIn and X.

Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website

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