Senior Director of Programming Operations
2 maanden geleden
Position Overview
The Senior Director, Head of Programming, will play a pivotal role within the Development Operations Leadership Team, responsible for shaping the strategic direction and identifying key development areas within the organization. This role ensures that all teams and personnel align with shared objectives and collaborate effectively.
Key Responsibilities:
- Drive the overarching strategy for programming activities in close partnership with the Heads of Biostatistics and Data Management.
- Oversee programming efforts related to clinical trials and regulatory submissions, ensuring collaboration with relevant stakeholders across functions.
- Support the advancement of new therapies by maintaining data integrity, consistency, and adherence to established standards, producing high-quality data summaries for informed decision-making.
- Facilitate operational support for Data Management, Statistics, Drug Safety, Medical, and Clinical Pharmacology across various trials and programs.
- Establish standard processes and templates to ensure compliance with ICH-GCP and other regulatory guidelines for quality and timeliness in documentation.
- Manage outsourced programming activities, including the selection and oversight of programming teams, ensuring clarity in work orders and expectations.
Leadership and Development:
The Senior Director is expected to exemplify leadership qualities, actively engaging in departmental initiatives, sharing lessons learned, and contributing to the department's strategic goals. This role involves fostering strong relationships and effective communication with internal teams such as Data Management, Biostatistics, and Regulatory Affairs, as well as external partners and regulatory bodies.
Qualifications:
- A Bachelor's degree or equivalent experience is required.
- A minimum of 15 years in clinical trial management, with at least 10 years in a leadership role overseeing skilled teams.
Essential Skills:
- Proficiency in SAS programming or similar languages (e.g., R, Python).
- Strong analytical and problem-solving capabilities.
- Familiarity with CDISC SDTM and ADaM data models.
- Ability to write efficient, maintainable, and well-documented code.
- Excellent organizational and planning skills, with the ability to manage multiple tasks effectively.
- Exceptional communication skills and a collaborative mindset.
Work Environment:
This position supports a flexible working environment, promoting a balance between professional responsibilities and personal well-being. The role encourages collaboration and innovation within a dynamic team setting.
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