Director of Clinical Operations

Job Type Full-time Description

BioAge Labs is a venture-backed biopharmaceutical company headquartered in Richmond, CA.  Because aging is the driver of many highly morbid, chronic medical conditions that reduce the length and quality of life, we are developing therapeutics that target the fundamental mechanisms of aging, with the goal of treating disease and increasing healthy lifespan. 

We are seeking a Director of Clinical Operations to oversee the execution of clinical programs and trials under the VP of Clinical Operations. 

The job: Through supporting the internal study team and maintaining relationships with external vendors, this role is responsible for ensuring that all clinical operational activities are executed per the budget and timeline and that quality and GCP standards are met. The Director could serve as the lead on smaller programs and will act in the lead capacity for vendor escalation on projects.

Essential Job Duties:

• Responsible for the execution of clinical programs and trials by managing the timeline, budget, and resources of clinical activities. This includes close supervision of CROs and vendors for data management, study drug management and supply, biostatistics, pharmacovigilance, central laboratories, and pharmacokinetics. 
• Supports the clinical study team responsible for trial execution by maintaining effective relationships through open communication, partnership, and collaboration with internal stakeholders and external partners. 
• Facilitates productive communications with clinical sites to achieve the biggest impact on subject enrollment and protocol compliance. 
• Ensures quality data through the drafting and review of protocols, clinical study reports, and other study documentation as well as oversight of ongoing data reviews and clinical site monitoring throughout the study. 
• Assures GCP compliance through the drafting and review of standard operating procedures as well as the facilitation of audits with Quality. 
• Participates in the preparation of regulatory filings as needed. 
• Provides strategic input to the clinical development program. 
• Mentors other clinical operations study team members. 
• Develops key performance indicators (KPI)’s and ensure risk mitigation plans are in place for each program.
• Provide BioAge teams (e.g. Core team and Clinical Science) with strategic operational input, including cost, feasibility of study design, timelines, logistics and allocation
• Has clinical operational oversight for assigned program and is accountable to support achievement of assigned business goals
• Knowledge and understanding and management of external data management and clinical systems vendors, including being an effective end-user of Clinical Systems (e.g. EDC, CTMS, eTMF, etc.)
• Participates in the development of clinical operations process standards, policies and SOPs
• Directs exploratory feasibility exercises and oversees identification of study sites at program or indication level

Required Skills and Abilities:

• Clinical research experience, including onsite monitoring
• Creation, tracking, and closeout of budgets and timelines
• Ability to develop operational strategy for clinical programs, including development of timelines, Key performance indicators, project and risk management plans and budgets
• Ability to work in an adaptive environment by remaining flexible, proactive, and efficient
• Strong verbal and written communication skills
• A highly collaborative person who can respond to constantly changing circumstances and needs
• Strong leadership skills, with demonstrated project or program management and critical thinking skills
• Strong site management and Key Opinion Leader interaction skills
• Ability to mentor others
• Advanced proficiency in Microsoft Office, Adobe PDF, MS Excel or smartsheets, Gmail, Zoom/MS Teams, Google Meet, Sharepoint, Docusign, electronic data capture, interactive response technology, electronic trial master files and investigator site files

Education and Qualifications:

• BA/BS degree minimum preferably in a life science related field or equivalent
• 15 years experience in clinical research minimum.
• Demonstrated knowledge of all phases of the drug development process at a Biotechnology or pharmaceutical company
• Experience managing Clinical Research Organizations (CROs), central laboratories, IXRS, EDC and other vendors
• Expert knowledge of ICH/GCP guidelines, regulatory requirements, and clinical trial operations

Physical Requirements:

Employees must meet certain physical requirements that are compliant with the Americans with Disabilities Act (ADA). It is our pol