Director, Clinical Operations

Job Type Full-time Description

BioAge Labs is a clinical-stage biotechnology company that is harnessing the biology of human aging to develop novel targets and therapies for metabolic diseases.

We are seeking an experienced Director of Clinical Operations to lead the oversight of BioAge’s exciting Phase 2 clinical trial focused on metabolic research related to obesity and cardiometabolic diseases.

The Role: The Director of Clinical Operations reports to the VP of Clinical Operations on a small internal team, and oversees the execution of clinical programs and trials in partnership with Clinical Research Organizations. 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 for the study they are overseeing. The Director could serve as the lead on smaller programs and will act in the lead capacity for vendor escalation on projects.

You: You prefer working in small, fast paced biotech environments where you’re interacting at all levels of the organization. You have experience providing oversight on all trial related activities from study start up through close out on multiple trials using multiple CRO’s. You like working with data and metrics, anticipating and then mitigating risks, and managing study timeline deliverables and budgets. You are productive and motivated while working remotely, and have the flexibility to travel up to 35% when needed.

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/supply, biostatistics, pharmacovigilance, as well as central, bioanalytical and CORE laboratories. 
• Leads the clinical trial execution team by maintaining effective relationships through open communication, partnership, and collaboration with internal stakeholders and external partners to meet trial and corporate 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.)
• Directs exploratory feasibility exercises and oversees identification of study sites at program or indication level
• 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, informed consents, 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. 
• Develops key performance indicators (KPI)’s and ensure risk mitigation plans are in place for each trial.
• Provide BioAge teams (e.g. Core team and Clinical Science) with strategic operational input, including cost, feasibility of study design, timelines, logistics and allocation
• Participates in the preparation and review of regulatory filings as needed. 
• Mentors other clinical operations study team members. 

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, enrollment projections, 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, 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 (CRO