Director, Clinical Research Development - California, United States - Life Science People

Description

We are working with a renowned immunology-focused organization, dedicated to revolutionizing the treatment and prevention of infectious diseases and critical conditions, is seeking a Director of Clinical Research. This position offers a pivotal role within the clinical team, involving comprehensive involvement from initial conceptualization to worldwide registration.

It will be based in San Francisco, CA, preferred candidates are those open to working on-site, although remote options within the United States will be considered.

Responsibilities:

• Collaborate with clinical team on scientific aspects of trial conceptualization and planning.
• Oversee ongoing and planned clinical trials, including publication planning and engagement in Investigator Meetings and Scientific Advisory Boards.
• Lead evaluation of business development opportunities for future clinical development.
• Provide high-level input into Phase I-IV clinical trial protocol design, study reports, and Health Authority inquiries.
• Monitor clinical trials, ensuring adherence to regulatory requirements and industry standards.
• Contribute to regulatory document preparation/review and data analysis for internal assessment and presentation.
• Serve as a scientific and clinical resource within the organization, offering guidance to various departments.
• Maintain relationships with therapeutic area opinion leaders globally.

Qualifications:

• MD/PhD or PharmD with a minimum of six years' experience in pharmaceutical industry clinical research.
• Familiarity with infectious diseases, immunology, or oncology; BLA or NDA experience is advantageous.
• Demonstrated experience in developing clinical strategies, with global trial and phase 3 experience preferred.
• Strong leadership skills with the ability to influence in scientific and interpersonal contexts.
• Knowledge of good clinical practices and International Conference on Harmonization Guidelines.

What We Offer:

• Competitive salary range ($190,000.00 to $280, based on experience and qualifications.
• Comprehensive benefits package including health, dental, vision, life and disability insurance, non-accrual paid time off, commuter benefits, education reimbursement, 401K match, and more.
• Equal opportunity employer committed to a diverse and inclusive workplace.