Director – Clinical Development

This is a fully remote position, open to applicants in California.

📋 Description

• Assist in the planning and implementation of clinical development initiatives, ensuring they align with the overall program strategy and timelines.

• Contribute to the assessment and enhancement of development strategies aimed at reducing risks and advancing clinical assets effectively.

• Engage in the planning, execution, and cross-functional coordination of clinical trials from early to late stages.

• Aid in the creation, review, and enhancement of clinical trial protocols, guaranteeing scientific integrity, ethical standards, and regulatory compliance.

• Offer medical and clinical insights throughout the clinical trial lifecycle, including safety monitoring, data interpretation, and risk management.

• Collaborate with biometrics and medical writing to ensure clinical and nonclinical studies are designed, analyzed, and summarized properly, adhering to timelines, quality standards, and relevant regulatory requirements.

• Work together with regulatory affairs and other departments to support regulatory strategies, clinical trial submissions, and responses to health authorities.

• Assist in data analysis and reporting tasks, providing strategic insights to guide decision-making and regulatory submissions.

⛳️ Requirements

• Bachelor’s Degree is required.

• Advanced degree is preferred.

• At least 6 years of clinical development experience within the biotechnology or pharmaceutical sectors.

• Experience managing multiple, complex programs or studies.

• Comprehensive understanding of the complete management of clinical trial execution, clinical drug development, and operations.

• Profound knowledge of global regulatory standards and experience guiding clinical trials to approval.

• Excellent written and verbal communication skills, with the ability to articulate complex concepts clearly.

• A proactive approach and capacity to work hands-on in a detail-oriented, fast-paced, entrepreneurial setting.

• Strategic agility coupled with strong critical thinking and logical reasoning abilities to analyze challenges.

• Capability to build and sustain collaborative working relationships with both 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.