GENERAL SUMMARY:

The Director, Clinical Operations supports the VP in leading and managing the Clinical Operations group to design and execute clinical trials per corporate objectives, corporate standard operating procedures (SOPs), and Good Clinical Practice (GCP).

Essential Duties & Responsibilities:

• Partner with VP, Clinical Operations & Data Management or Sr. Director of Clinical Operations to develop and manage program operational strategies and plans for all products in compliance with corporate objectives and timelines
• Develop resourcing plans and clinical trial timelines across assigned clinical programs including hiring, training, mentoring, and retaining staff
• Participate as Clinical Operations subject matter expert (SME) on annual budgets to support clinical trial activities and required infrastructure
• Participate as an SME for clinical operations related due diligence activities
• Independently oversee day-to-day activities of the Clinical Trial Operations for assigned programs
• Collaborate with Finance on annual budget planning (external spend) as well as quarterly budget reviews and re-forecasts; overseeing clinical vendor outsourcing strategy within their assigned program(s);
• Actively participating in the selection of vendors to support 4DMT clinical trials as well as active governance of them; participating and/or leading vendor governance committees
• Directly manage and actively partner with Clinical Trial and Program Leads to ensure that clinical trial protocols are executed to meet corporate objectives and in compliance with corporate SOPs and GCP
• Sit on product cross-functional core teams as Clinical Operations SME, as required
• Develop and present program or departmental initiatives and/or activities to Clinical Development leadership and/or Executive Team
• Support development of and identify Clinical SOPs and work instructions to ensure consistency across 4DMT trials and SETs
• Ensure program adherence to SOPs, work instructions, and other governance documents, including timely training
• Partner closely with Quality to ensure that their assigned programs always remain inspection ready
• Collaborate with Regulatory Affairs and Clinical Sciences on the creation of regulatory submissions and compliance to regulatory requirements (eg, Clincialtrials.gov) for assigned program(s)
• Partner with other group and/or functional leaders across 4DMT to identify and to implement best practices to ensure that 4DMT meets corporate objectives and adapts to changing business needs
• Actively support and foster cross-functional communication.

QUALIFICATIONS:

Education:

• BS/BA in Life Science or related discipline; advanced degree (MS, MPH, MHS, Ph.D., MBA) preferred.

Experience:

• A minimum of 10 years of applicable industry experience in drug development (Clinical Operations) late-stage (Phase 3), and 5 years direct line management experience.

Core Competencies, Knowledge and Skill Requirements:

• Proven ability to recruit, retain, organize, and motivate clinical operations personnel
• Ability to communicate to leadership team on Clinical Operations updates and priorities as well as to advocate for required budget and resources
• Ability to manage and oversee large scale programs that have corporate-wide impact
• Ability to develop and manage functional and clinical trial-specific budgets
• Must be self-motivating; prioritize and manage a large volume of work; show attention to detail
• Strong interpersonal skills are essential as this individual will partner with various team members and functional groups for clinical trials and business performance
• Thorough knowledge and understanding of FDA and ICH Guidelines, GCP, medical terminology, and clinical trials
• Ability to be flexible and adaptable to changing business needs
• Relevant experience in clinical trial execution across all phases.

Communication & Interpersonal Skills:

• Excellent communication and interpersonal skills
• Must be able to write clearly and summarize information effectively
• Must be able to present complex information to various audiences

BASE SALARY COMPENSATION RANGE:

Bay Area-based candidates: $230,000/yr. - $253,000/yr.

National range: $202,000/yr. - $235,000/yr.

Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.