Director – Clinical Development
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Job Description
Director/Senior Director, Clinical Development at Codera managing clinical trial strategy and execution for drug development programs. Collaborating cross-functionally to ensure high quality clinical data and regulatory compliance.
Responsibilities:
- Support the planning and execution of clinical development programs, ensuring alignment with overall program strategy and timelines
- Contribute to the evaluation and refinement of development strategies to mitigate risks and advance clinical assets efficiently
- Participate in the planning, delivery and cross-functional coordination of clinical trials from early to late phases
- Assist in the development, review and refinement of clinical trial protocols, ensuring scientific rigor, ethical conduct and regulatory compliance
- Provide medical and clinical input throughout the clinical trial lifecycle, including safety monitoring, data interpretation and risk management
- Partner with biometrics and medical writing to ensure clinical and nonclinical studies are designed, analyzed and summarized appropriately in accordance with timelines, good quality practices and applicable regulatory requirements
- Collaborate with regulatory affairs and other departments to support regulatory strategies, clinical trial submissions and responses to health authorities
- Support data analysis and reporting activities, contributing strategic insights to inform decision-making and regulatory submissions
Requirements:
- Bachelor’s Degree required
- Advanced degree preferred
- Minimum 6 years of clinical development experience within the biotechnology or pharmaceutical industry
- Experience with multiple, complex programs or studies
- Detailed understanding of end-to-end management of clinical trial conduct, clinical drug development and clinical trials operations
- Deep understanding of global regulatory requirements and experience navigating clinical trials to approval
- Outstanding written and verbal communication skills, including the ability to use clear language to explain complex ideas
- Possess a willingness and ability to work hands-on in a detail-driven, fast-paced, entrepreneurial environment
- Strategic agility with strong critical and logical thinking and ability to analyze problems
- Ability to establish and maintain collaborative working relationships with internal and external stakeholders
Benefits:
- employer sponsored insurance plans including medical, dental and vision coverage
- generous paid time off
- retirement plan options
- additional wellness and professional development programs
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