Associate Director, Global Trial Lead

Genmab•Plainsboro Township, NJ

40d

About The Position

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! 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.

Requirements

Required experience working in a complex, global and matrixed organization.
Required Pharmaceutical Industry Experience With Knowledge Of ICH/GCP Regulations.
Required oncology or TA specific drug development experience and various phases of development.
Required Experience Mentoring Others.
Required matrix leadership experience (ability to lead without authority).
Expected To Have Advanced Knowledge InEnd-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.

Nice To Haves

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

Responsibilities

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.
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.
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.
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

Benefits

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

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