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 within the organization. This leadership position ensures alignment across teams and fosters a unified approach to achieving organizational objectives.

Key Responsibilities

The incumbent will spearhead the strategic initiatives related to programming activities at Genmab, collaborating closely with the Heads of Biostatistics and Data Management. Responsibilities include:

  • Overseeing programming activities for clinical trials and regulatory submissions, ensuring collaboration with relevant stakeholders.
  • Supporting the development of innovative therapies by maintaining data integrity and adherence to standards, producing high-quality data summaries for decision-making.
  • Operationally assisting various functions including Data Management, Statistics, Drug Safety, and Clinical Pharmacology across multiple trials and programs.
  • Establishing standard processes and templates to ensure regulatory filings and clinical documentation meet ICH-GCP and other regulatory guidelines.
  • Managing outsourced programming activities, including selection and oversight of programming teams, ensuring clarity in work orders and expectations.

Leadership and Development

The Senior Director is expected to be a role model within the department, actively engaging in initiatives, sharing lessons learned, and contributing to the overall strategy. This role requires building strong relationships with internal teams such as Data Management, Biostatistics, and Regulatory Affairs, as well as external stakeholders including partners and regulatory authorities.

Qualifications

To excel in this role, candidates must possess:

  • A Bachelor's degree or equivalent experience.
  • A minimum of 15 years in clinical trial management, with at least 10 years in a leadership capacity.
  • Extensive experience with NDA, MAA, and BLA filings.
  • Proficiency in programming languages such as SAS, R, or Python.
  • Strong analytical, problem-solving, and communication skills.

Work Environment

This position supports a flexible working environment, promoting a balance between professional responsibilities and personal well-being. Genmab is committed to fostering a collaborative and innovative workplace culture.



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