Senior Director of Programming Operations

7 dagen geleden

Utrecht, Utrecht, Nederland Genmab Voltijd

Position Overview

The Senior Director, Head of Programming will play a pivotal role within the Development Operations Leadership Team, shaping the strategic direction and identifying key development areas for the organization. This leadership position ensures that all teams align with shared objectives and collaborate effectively.

Strategic Responsibilities

In this capacity, the individual will spearhead the programming strategy related to clinical and regulatory activities at Genmab. This involves close collaboration with Heads of Biostatistics and Data Management to oversee programming activities associated with development programs, clinical trials, and regulatory submissions.

Data Integrity and Quality Assurance

The Senior Director will ensure the integrity, consistency, and adherence to data standards, producing high-quality data summaries for informed decision-making. This role also entails operational support across various functions, including Data Management, Statistics, Drug Safety, and Clinical Pharmacology.

Process Standardization

Establishing standard processes, templates, and clinical standards is crucial to maintaining the quality and timelines of regulatory filings and clinical documentation, in compliance with ICH-GCP and other relevant guidelines.

Outsourcing Oversight

The role includes overseeing outsourced programming activities, which involves selecting and managing external programmers while ensuring clear expectations and responsibilities are outlined in work orders and manuals.

Leadership and Mentorship

The Senior Director is expected to act as a role model, engaging proactively in departmental activities, sharing lessons learned, and leading various initiatives. Building strong relationships and maintaining open communication with internal and external stakeholders is essential.

Key Responsibilities:

  • Drive the development of processes and standards within programming, focusing on continuous improvement.
  • Manage resource planning and outsourcing of programming activities.
  • Prepare for and participate in audits and inspections.
  • Engage in due diligence activities as necessary.
  • Lead scientific forums and workshops to promote knowledge sharing.
  • Participate in cross-functional projects and task forces.
  • Oversee the management and development of the Programming Team.
  • Support the global expansion of Development Operations.
  • Ensure compliance and training for team members.
  • Maintain knowledge of therapeutic and regulatory guidelines to enhance programming processes.

Qualifications:

  • Bachelor's degree or equivalent experience.
  • 15+ years in clinical trial management, with at least 10 years in a leadership role.

Competencies:

  • Proficiency in SAS programming or similar languages (R, Python).
  • Strong analytical and problem-solving abilities.
  • Familiarity with CDISC SDTM and ADaM data models.
  • Excellent communication and organizational skills.
  • Ability to manage multiple tasks effectively while maintaining quality.

Work Environment:

This role offers flexibility in work arrangements, promoting a balance between professional and personal life.

About You:

  • Passionate about innovative cancer treatment.
  • Committed to excellence and collaboration.
  • Adaptable and innovative in problem-solving.

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