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 position ensures that all teams and personnel align with shared objectives and collaborate effectively.
Key Responsibilities:
- Lead the strategic initiatives concerning 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 various functions.
- Support the advancement of new therapies by maintaining data integrity, consistency, and adherence to established standards, while producing high-quality data summaries for informed decision-making.
- Provide operational support to the Data Management, Statistics, Drug Safety, Medical, and Clinical Pharmacology teams across multiple trials and programs.
- Establish and maintain standard processes, templates, and clinical standards to guarantee the quality and timeliness of regulatory filings and clinical documentation in compliance with ICH-GCP and other regulatory guidelines.
- Manage outsourced programming activities, including the selection and oversight of programming teams, ensuring clarity in expectations and responsibilities.
- Act as a role model within the department, engaging proactively in departmental activities, sharing lessons learned, and contributing to the overall strategic vision.
- Foster strong relationships and maintain open communication with internal teams such as Data Management, Biostatistics, and Regulatory Affairs, as well as external stakeholders including partners and regulatory authorities.
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 managing high-performing teams.
- Proficiency in SAS programming or similar languages such as R or Python.
- Strong analytical and problem-solving capabilities, with a thorough understanding of CDISC SDTM and ADaM data models.
- Exceptional communication and organizational skills, with the ability to manage multiple tasks effectively.
Work Environment:
This role supports a flexible working environment, promoting a balance between professional responsibilities and personal well-being. The company values collaboration and innovation, encouraging employees to connect and share ideas in a dynamic setting.
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