Senior Director of Programming Operations
7 dagen geleden
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 position is crucial in ensuring that all teams align with common objectives and function cohesively.
Key Responsibilities
- Lead the strategic initiatives related to programming activities in collaboration with the Heads of Biostatistics and Data Management.
- Oversee programming tasks across clinical and regulatory functions, ensuring compliance with relevant stakeholders.
- Facilitate the development of innovative therapies by maintaining data integrity and producing high-quality data summaries for decision-making.
- Support various functions, including Data Management, Statistics, Drug Safety, and Clinical Pharmacology, across multiple trials and programs.
- Establish and maintain standard processes and templates to ensure timely and quality regulatory submissions.
- Manage outsourced programming activities, including selection and oversight of programming personnel, ensuring clarity in expectations and responsibilities.
Leadership and Collaboration
The Senior Director is expected to act as a role model, actively engage in departmental initiatives, and lead various projects that contribute to the overall strategy of the department. Building strong relationships and maintaining open communication with internal teams and external stakeholders is essential.
Qualifications
- A Bachelor's degree or equivalent experience is required.
- At least 15 years of experience in clinical trial management, with a minimum of 10 years in a leadership role.
- Proficiency in programming languages such as SAS, R, or Python.
- Strong analytical and problem-solving skills, with a thorough understanding of CDISC SDTM and ADaM data models.
- Excellent communication, planning, and coordination abilities.
Work Environment
This role supports a hybrid working model, promoting a balance between remote and in-office collaboration.
About Genmab
Genmab is dedicated to transforming the lives of patients through innovative cancer treatments. We value rigor, collaboration, and a commitment to excellence in all our endeavors.
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