Director/ Sr. Director of Clinical Operations at BIOAGE LABS
Richmond, CA, US
BioAge Labs is a venture-backed biopharmaceutical company headquartered in Richmond, CA.  BioAge believes that aging is the fundamental driver of many highly morbid, chronic diseases that reduce both the quantity and quality of life. We believe that intervening directly in the aging process will be the most impactful way to decrease the burden of disease and increase healthspan in an aging population.
 
The Director/Sr. Director of Clinical Operations is responsible for leading the execution of clinical programs on schedule and on budget. The Director will typically have oversight by the VP of Clinical Operations but will serve as the lead on larger, critical programs and will act in the lead capacity for vendor escalation on large projects (consistent with their experience, skill level, and capacity to manage studies).

Responsibilities

    • Must have at least 10-12 years clinical research and development experience (preferred, but consistent with performance and capabilities)
    • Responsible and accountable for defining the operational strategy across a large therapy area(s)
    • Identifies, sponsors and/or leads, key organizational process improvement initiatives 
    • Directs the development of process standards, policies and SOPs
    • Participates in the development and implementation of departmental strategy and infrastructure
    • Leads Clinical R&D contracting and outsourcing activities on a program or project level
    • Develops, mentors, and plans for succession of leadership
    • Develops internal metrics and industry benchmarks (where available) to assess organizational performance and optimize operational excellence
    • Responsible for determining and communicating to senior management adequate resource requirements
    • Ensures that staff are able to provide Clinical teams with strategic operational input, including cost, feasibility of study design, timelines, logistics and allocation
    • Develops assigned staff competencies and identifies skill gaps to ensure their ability to deliver the required study programs
    • Sets performance standards and is accountable for developing performance metric reports across assigned therapy area
    • May have line management responsibility for Associate Director level staff and below
    • May be the point of contact for more strategic partnerships with external partners
    • Interacts with senior and executive level management to report on study or  program milestones

Qualifications, Skills, & Abilities

    • BA/BS degree minimum, advanced degree preferred
    • A minimum of 10-12 years of experience in Clinical Operations for Director/Sr. Director position (preferred, but consistent with performance and capabilities)
    • Solid technical knowledge of relevant therapeutic area strongly preferred
    • Experience managing and negotiating with Clinical Research Organizations (CROs), central laboratories, and other vendors highly desirable
    • Demonstrated ability to develop operational strategy for clinical programs, including development of timelines, project plans, risk management/contingency plans and budgets
    • Line and matrix management experience required
    • Experience and discipline in document maintenance and management
    • Good knowledge of the clinical development process, understanding concepts of Phase I-IV
    • Expert knowledge of ICH/GCP guidelines, regulatory requirements and clinical trial operations
    • Experience with and excellent verbal and written communication with senior and executive management
    • A highly collaborative person who is able to respond to constantly changing circumstances and needs
    • Strong leadership skills, with demonstrated project or program management
    • Strong site management and Key Opinion Leader interaction skills valued
    • Ability to mentor others with exceptional communication and interpersonal skills
    • Advanced proficiency in Microsoft Office, Microsoft Project
At BioAge, we pride ourselves in giving employees many opportunities for career development including a generous annual budget for continued learning, a direct and open-door environment, and a dedication to training and skill development. Employees also enjoy competitive pay, generous health and retirement benefits, paid time off, and flexible hours. 
 
Goal-driven -- We say we want to do and we do it
Integrity -- We are driven to provide the field of science answers of the highest quality and replicability
Family -- As part of a small growing biotech startup, you will experience a supporting and caring culture
Innovation -- Innovation defines biotechnology and runs in the veins of all employees at BioAge
Leadership -- We strive to be a leader in the field of aging worldwide