The Associate Director of Clinical Operations will oversee clinical operations activities, including clinical project management, clinical site management (essential regulatory documents, study start-up, site monitoring), and/or clinical systems management (CTMS, TMF documentation review/collection). This role requires an understanding and working knowledge of FDA requirements, GCPs/ICH guidelines, data management/analysis, and scientific/technical writing processes and requirements. The Associate Director will support one or more government or commercial contracts in multiple therapeutic areas such as infectious disease (vaccines and therapeutics), oncology, medical devices, or drug abuse. The position entails project management oversight for multiple functional areas within one or more complex drug development programs, managing deliverables within budget and to well-defined timelines.
ResponsibilitiesProvide oversight of clinical operations activities, including clinical project management, clinical site management, and clinical systems management.Support government or commercial contracts in various therapeutic areas.Manage project deliverables within budget and timelines for complex drug development programs.Communicate effectively in a matrix management organization and represent the clinical team during cross-functional collaboration.Provide operational expertise to support program/project-level functional areas.Collaborate with Directors and other departments to lead clinical operations strategy and vision.Inform division leadership on the status of clinical programs/projects and potential issues/mitigation.Ensure documentation of processes and workflows are followed and determine actions to prevent and remediate delays.Identify gaps and propose solutions to improve efficiency and quality of deliverables.Support and comply with the company’s Quality Management System policies and procedures.Drive innovative project and company performance improvement solutions, including corrective and preventive (CAPA) actions.Perform risk-based quality content reviews and monitor internal/external KPIs.Contribute to corporate initiatives such as streamlining and process improvement, and SOP development.Manage line responsibilities, including staff hiring activities and resource management.Participate in proposal writing, budget development, and bid defense meetings.Support inspection readiness and assist in department audit preparation, post-inspection activities, and follow-up.Essential SkillsBroad multidisciplinary understanding of pharmaceutical clinical research and development processes.Hands-on regulatory, clinical operations, or clinical trial monitoring/management experience.Ability to mentor staff and achieve high-quality performance through risk management and corrective/preventive actions.Strong facilitation, presentation, problem-solving, and conflict resolution skills.Excellent oral and written communication skills, with strong attention to detail.Experience in the use and development of clinical research databases/systems/tools.Strong leadership skills including change management, people development, strategic thinking, and influencing.Advanced ability to manage team resources to ensure attainment of department objectives.Expertise in Microsoft Word, PowerPoint, and Excel, and experience with Microsoft Project.10 years minimum experience in the pharmaceutical or biotechnology industry, including at least 6 years of project management or equivalent clinical trials and operations management experience.Additional Skills & QualificationsProposal writing and bid defense skills.Background in Infectious Disease/HIV clinical trials and/or Oncology.Experience in the conduct of Phase 1 protocols or prior work on a government contract.
Pay and Benefits
The pay range for this position is $135000.00 - $175000.00/yr.
Medical Insurance - Preferred Provider Organization (PPO) • Prescription Drug • Dental • Vision • Flexible Spending • Dependent Care • Health • Life Insurance • LTD Insurance (Eligibility for health benefits is the first month following the date of hire.)
Retirement
• Pre-tax salary deferrals from 1% - 50%
• Company match
• Discretionary profit-sharing distribution
(Eligibility for the 401(k) plan starts after 30 days of employment.) Leave • 15 days per year (5.00 hours per pay period) (See the adjacent table for increases based on tenure.)
Holidays
• 11 Company Recognized Holidays Additional Benefits • Tuition Assistance • Professional Development • Corporate Membership Rate at Sport & Health Clubs
Workplace Type
This is a hybrid position in Bethesda,MD.
Application Deadline
This position is anticipated to close on Feb 24, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & InclusionAt Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our peopleThe company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.