Vice President, Clinical Development
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Job Description
Vice President, Clinical Development overseeing drug development strategy and execution at Codera. Leading clinical trials and ensuring compliance with regulatory guidelines and oversight of biometrics.
Responsibilities:
- Oversee clinical development programs including strategic planning and execution of clinical trials
- Evaluate and refine development strategies to mitigate risks and expedite the advancement of assets
- Direct the planning, delivery and leadership of clinical trials from early to late phases
- Lead the development and refinement of clinical trial protocols, ensuring scientific rigor, ethical considerations and compliance with regulatory guidelines
- Assume medical and clinical accountability throughout the clinical trial lifecycle, including safety monitoring, data interpretation and risk management
- Oversee biometrics and medical writing to ensure all clinical and nonclinical studies are designed, analyzed and summarized appropriately in accordance with timelines, good quality practices and applicable regulatory requirements
- Collaborate with the Vice President, Regulatory Affairs in the development and execution of regulatory strategies to facilitate successful clinical trial approvals and submissions
- Direct data analysis and reporting activities, providing strategic insights to support decision-making and regulatory submissions
Requirements:
- Bachelor’s Degree required
- Advanced degree preferred
- Minimum 10 years of clinical development experience within the biotechnology or pharmaceutical industry, with at least 5 years’ experience leading teams in the progression of drug candidates through early-to-late development and regulatory submission
- Experience overseeing 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 successful track record of navigating clinical trials to approval
- Excellent business acumen and demonstrated ability to engage, lead and align teams to achieve business and program objectives
- 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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