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 (CROs), central laboratories, IXRS, EDC and other vendors
• Expert knowledge of ICH/GCP guidelines, regulatory requirements, and clinical trial operations
  
  

Our Company

BioAge is a clinical-stage biotechnology company that is harnessing the biology of human aging to develop novel targets and therapies for metabolic diseases. The company’s lead program, azelaprag, is a potential first-in-class oral APJ agonist entering Phase 2 trials in combination with tirzepatide for the treatment of obesity in older adults. Azelaprag has the potential as an oral regimen to amplify weight loss and improve body composition in patients on obesity therapy with incretin drugs. BioAge’s preclinical programs address key pathways in metabolic aging, based on novel insights from its discovery platform built on human longevity data. To date, BioAge has raised more than $300 million from a top-tier syndicate of investors and pharma companies.

Our workplace

BioAge offers competitive salary, a comprehensive compensation package, and generous paid time off in addition to company-observed holidays. We provide comprehensive health and wellness benefits (medical, dental, and vision insurance) and a 401(k) retirement savings plan with matching employer contributions, and we support families through childcare and fertility benefits. We also pride ourselves in giving employees many opportunities for career development, including a generous annual budget for continued learning and a dedication to training and skill development. The salary for this role is expected to be approximately $200,000 - $240,000 for someone who meets all of the minimum qualifications as listed for the role, and may be adjusted accordingly for someone with more or less experience as a Director or Senior Director. We are open to the concept that different experience levels add value to the team in different ways, and therefore will consider a variety of experience and offer commensurate pay.

At BioAge, we embrace diversity and differences while we learn from each other, and we believe that every team member has an important role to play. We are an equal opportunity employer. BioAge prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. BioAge conforms to the spirit as well as to the letter of all applicable laws and regulations.

Physical Requirements:

Employees must meet certain physical requirements that are compliant with the Americans with Disabilities Act (ADA). It is our policy to provide reasonable accommodations when requested to enable individuals with disabilities to perform the essential functions of the job unless such accommodations would cause undue hardship.

• Visual Requirements: Ability to effectively utilize a computer and other communication tools to access, enter, and interpret data. Adequate vision required to perform job duties effectively (reasonable accommodations available).
• Communication Abilities: Must be capable of communicating effectively with teams and management via various electronic media and in-person when necessary. Ability to express and exchange ideas via spoken word and to perceive detailed information through oral communication.
• Manual Dexterity: Sufficient manual dexterity required for operating a computer and other office devices.
• Mental Acuity: Ability to concentrate on detailed information and tasks for extended periods. Capable of making sound decisions and solving problems based on data analysis.
• Sedentary Nature: This position is primarily sedentary, with occasional walking, standing, and/or stretching required for relief during extended hours at the workstation.
• Work Environment Adaptability: Ability to effectively manage a work environment that is free from significant distractions. Ability to set up and maintain an ergonomic and safe home office environment.
• Stress Management: Capability to manage work-related stress in a fast-paced environment, including handling urgent project deadlines and sensitive information.
• Travel: The role may occasionally require travel or in-person engagements. Travel may vary up to 35% based on needs.
• Emergency Response: Ability to respond promptly to emergencies as needed.