Associate Director, Global Trial Lead

n we would love to have you join us!

As the Associate Director, Global Trial Lead (GTL) you are responsible 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.

We have a hybrid working environment, with 2-3 days in the office per week.

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.

Additional Responsibilities:

• Inform overall strategy and the synopsis development in the CDT through cross-functional teams within clinical operations

• Proactively engage with internal and external stakeholders (e.g. CTMs, cross-functional teams, project board, CRO project directors, KOLs, partners) to drive alignment towards project goals

• Participate development, monitoring, review, and update of trial/project budgets in collaboration with HoDs and CTMs

• Drive systems for timely documentation as well as compliance with regulations, SOPs, ICH/GCP, and Code of Business Ethics

• Guide systemic improvements based on learnings across trials and projects

• Oversee and participate in activities related to audits and inspections, as well as follow-up on findings within own projects

• Lead and participate in cross-functional working groups/projects/task forces

• Collaborate with external partners/industry peers and scan the landscape for exploration and adoption of cutting-edge methods to address internal challenges/needs

• Train and mentor teams on emerging clinical trial best practices

Requirements:

• 10+ years of Pharmaceutical Industry Experience with knowledge of ICH/GCP Regulations required.

• Required experience working in a complex, global and matrixed organization.

• Required therapeutic area (TA)-specific drug development experience and various phases of development. Oncology experience highly desired.

• Required Experience mentoring others and matrix leadership experience (ability to lead without authority).

• Experience in late-phase development is highly preferred.

• Proven leadership experience with a strong focus on people management and developing others preferred

• Expected to have advanced knowledge in end-to-end trial planning and execution.

• Outsourcing and vendor management.

• Expected To Be Proficient In:

  • Project management skills and knowledge of tools and processes.
  • Regulatory submission knowledge.
  • Develop and monitor key performance metrics.
  • Excellent written and verbal communication skills.
  • Excellent negotiation, collaboration and interpersonal skills with ability to work effectively with others at all levels of the organization.
  • Strong trial planning and budget management skills.
  • Strong understanding of clinical trial processes, ICH-GCP regulations, and the clinical drug development lifecycle.
  • Ability to proactively identify risks, develop mitigation strategies, and resolve issues effectively.
  • Experience managing trials in global settings, with the ability to oversee complex, multi-regional operations.
  • Stakeholder management skills.

• Learning and developing strong program planning and budget management skills.

• Developing ability to drive working groups and lead process improvements, champion more efficient and effective methods/processes.

For US based candidates, the proposed salary band for this position is as follows:

$148,320.00 - $222,480.00

The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives.

When you join Genmab, you're joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for:

• 401(k) Plan: 100% match on the first 6% of contributions

• Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance

• Voluntary Plans: Critical illness, accident, and hospital indemnity insurance

• Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave

• Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support

• Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses

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 you're 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, 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.

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Please note that if you are applying for a position in the Netherlands, Genmab's policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.