Position Summary
The Director/Senior Director, Clinical Development will support the clinical development strategy and execution of Codera's domestic and international drug development programs. Reporting to the Vice President, Clinical Development, this role will contribute to the design, implementation and oversight of clinical trials across all phases of development. The Director/Senior Director, Clinical Development will collaborate cross-functionally to ensure high-quality clinical data, support regulatory interactions and provide medical and scientific input throughout the clinical trial lifecycle. This role will also support safety monitoring and pharmacovigilance activities in partnership with internal and external stakeholders.
Essential Duties and 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
Qualifications
- 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
The job description is not designed to cover or contain a comprehensive list of activities, duties or responsibilities that are required. They may change, or new ones may be assigned at any time with or without notice.
The estimated annual base salary for this position is $200,000 - $280,000 commensurate with experience and skills. This role may be eligible for discretionary bonuses and other incentive programs.
Codera provides a comprehensive benefits package designed to support employees' physical, mental and financial health and include employer sponsored insurance plans including medical, dental and vision coverage; generous paid time off; retirement plan options and additional wellness and professional development programs
