Clinical Operations Director

2 months ago

Reston, Virginia, United States Meet Full time
Associate Director Clinical Operations

The Associate Director of Clinical Operations plays a pivotal role in overseeing the planning, coordination, and execution of global clinical trials. This position is responsible for ensuring adherence to project milestones, managing financial aspects, and upholding quality standards in line with ICH/GCP guidelines, regulatory requirements, and internal SOPs.

This role involves crafting and implementing study execution strategies and leading a team of direct reports. The Associate Director cultivates a supportive environment that values authenticity and open communication, collaborating across teams to develop innovative solutions for both technical and business challenges.

Key Responsibilities:

  • Oversee clinical operations for assigned programs, ensuring compliance with GCP, ICH, and relevant regulations.
  • Manage global studies, directing Clinical Trial Managers and CRO Study Teams.
  • Contribute to clinical development planning and strategy.
  • Lead the selection and management of CROs, and oversee investigator recruitment, study start-up, enrollment, data collection, and drug projections.
  • Develop and manage project timelines to achieve departmental and corporate goals.
  • Identify and implement strategies to address study risks.
  • Track KPIs for assigned trials, including clinical reviews and data query resolution.
  • Provide senior management with timely updates on progress and changes in scope.
  • Oversee the preparation and content of investigator meetings.
  • Coordinate site outreach and enrollment activities.
  • Communicate regularly with key stakeholders, including Regulatory Affairs, Biostatistics, Data Management, Clinical Supply, Clinical Research, Legal, and Finance.
  • Contribute to clinical study reports, Investigator's Brochures, protocols, and other regulatory documents.
  • Ensure the Clinical Trial Master File is current and inspection-ready.
  • Assess enrollment feasibility across various indications.
  • Lead or co-lead the development of clinical documents and study-related plans.

Professional Experience / Qualifications:

  • Comprehensive knowledge of industry practices, outsourcing, and GCP system requirements.
  • Strong collaborative skills and the ability to build effective relationships across departments.
  • Documented training in FDA Regulations, GCP, and ICH guidelines.
  • Excellent communication and writing skills.
  • Effective in influencing and relationship-building.
  • Strong problem-solving skills and sound judgment.
  • Detail-oriented with experience managing and developing direct reports.
  • Willingness to travel domestically and internationally (10-15%).
  • Experience with regulatory authority inspections is a plus.

Preferred Education:

  • B.A. or advanced degree in biological sciences or a related field.

Preferred Experience:

  • At least 10 years of experience in clinical operations within biotech, pharmaceutical, or CRO environments, including 5 years managing global clinical trials.
  • Experience in both early and late phases of development and in immune-mediated diseases.

Preferred Computer Skills:

  • Proficiency in Microsoft Office (Word, Excel, Outlook), Smartsheet, electronic TMF, and electronic clinical technologies.

  • Clinical Operations Director

    4 weeks ago

    Reston, Virginia, United States Barrington James Full time

    Director Clinical OperationsBarrington James is seeking a seasoned Director Clinical Operations to lead our clinical research operations team.As a key member of our team, you will be responsible for creating and managing clinical research processes for CROs, Sponsors, and Sites.You will draw on your experience in business process improvement and your network...

  • Clinical Operations Director

    2 months ago

    Reston, Virginia, United States CARsgen Therapeutics Full time

    Clinical Operations DirectorAt CARsgen Therapeutics, we are seeking a highly experienced Clinical Operations Director to lead our clinical trials operations team. The successful candidate will be responsible for ensuring the smooth execution of clinical trials, from planning to completion, in accordance with regulatory requirements and company standards.Key...

  • Director of Clinical Operations

    2 weeks ago

    Reston, Virginia, United States N2S Healthcare Staffing Solutions LLC Full time

    **Job Summary**The Director of Clinical Operations is responsible for ensuring high-quality, patient-centered care through oversight of multiple sites and/or functional areas. This leader fosters a culture of accountability and collaboration, directing the development and implementation of strategies, policies, and procedures to support facility and/or...

  • Senior Director Clinical Pharmacology

    4 days ago

    Reston, Virginia, United States Clinical Dynamix Full time

    Key ResponsibilitiesThe Senior Director Clinical Pharmacology at Clinical Dynamix will drive all aspects of the translational strategy, including pharmacokinetic, toxicokinetic, and pharmacodynamic assessments, biomarker development, and biodistribution studies. They will be accountable for delivering key translational milestones from candidate selection to...

  • Senior Director, Clinical Pharmacology Lead

    2 weeks ago

    Reston, Virginia, United States Clinical Dynamix Full time

    Job SummaryClinical Dynamix is seeking a highly experienced Senior Director, Clinical Pharmacology to lead our translational science efforts. This role will drive all aspects of the translational strategy, including pharmacokinetic (PK), toxicokinetic (TK) and pharmacodynamic (PD) assessments, biomarker development and biodistribution studies.Key...

  • Clinical Operations Director/Senior Leader

    4 days ago

    Reston, Virginia, United States CARsgen Therapeutics Full time

    Clinical Operations Director Role at CARsgen TherapeuticsAs a Clinical Operations Director at CARsgen Therapeutics, you will play a vital role in ensuring the successful execution of clinical trials. Your primary responsibility will be to oversee the development and implementation of clinical trial strategies, ensuring compliance with regulatory requirements...

  • Clinical Director

    3 weeks ago

    Reston, Virginia, United States Independent Identity Full time

    About the Role:Independent Identity is seeking a highly experienced Clinical Director to lead our day-to-day operations and clinical programming. The successful candidate will be responsible for developing and implementing systems to facilitate effective clinical operations, creating and disseminating new training materials for staff, and promoting a...

  • Clinical Director

    3 weeks ago

    Reston, Virginia, United States InBloom Autism Services Full time

    About the RoleInBloom Autism Services is seeking a highly skilled and experienced Clinical Director to join our team. As a Clinical Director, you will be responsible for providing clinical oversight and implementing quality assurance processes for our clinical teams across two center locations.Key ResponsibilitiesProvide clinical oversight and implement...

  • Clinical Trials Director

    2 weeks ago

    Reston, Virginia, United States Inova Health Full time

    Inova Health is seeking a seasoned Clinical Trials Director to lead our Obstetrics Trials program. This leader must have a strong background in clinical research operations and experience in OB trials is preferred.The Clinical Trials Director will develop strategic approaches to ensure new business opportunities, including identifying key areas of...

  • Scientific Director, Oncology

    1 week ago

    Reston, Virginia, United States Clinical Care Options Full time

    Job Title: Scientific Director, OncologyClinical Education Alliance is a global leader in providing innovative and impactful healthcare education, insights, and communications. As a Scientific Director, Oncology, you will be responsible for developing and managing content for continuing education (CME/CE) and independent medical education (IME) programs.Key...

  • Associate Scientific Director, Oncology

    3 weeks ago

    Reston, Virginia, United States Clinical Care Options Full time

    Job Title: Associate Scientific Director, OncologyJob Summary:Clinical Education Alliance (CEA) is a global leader in providing innovative and impactful healthcare education, insights, and communications. We empower healthcare professionals with the tools and resources they need to stay current and improve patient outcomes.We are seeking an Associate...

  • Associate Scientific Director, Oncology

    1 week ago

    Reston, Virginia, United States Clinical Care Options Full time

    Job Title: Associate Scientific Director, OncologyReports to: Director, Scientific ServicesLocation: Homebased, USAJob Status: Full-time, ExemptJob Summary:Clinical Education Alliance (CEA) is a global leader in providing innovative and impactful healthcare education, insights, and communications. We empower healthcare professionals with the tools and...

  • Associate Scientific Director, Oncology

    3 weeks ago

    Reston, Virginia, United States Clinical Care Options Full time

    Job Title: Associate Scientific Director, OncologyJob Summary:Clinical Education Alliance (CEA) is a global leader in providing innovative and impactful healthcare education, insights, and communications. We empower healthcare professionals with the tools and resources they need to stay current and improve patient outcomes.We are seeking an Associate...

  • Clinical Director

    3 weeks ago

    Reston, Virginia, United States Helping Hands Family - Autism Services Full time

    Lead a Team of BCBAs at a Top-Rated ABA ProviderHelping Hands Family is a leading provider of autism services, and we're seeking a skilled Clinical Director to oversee our clinic operations. As a key member of our clinical leadership team, you'll be responsible for managing a team of BCBAs and RBTs, ensuring the delivery of high-quality services to our...

  • Ambulatory Operations Director

    2 weeks ago

    Reston, Virginia, United States Cross Country Healthcare Full time

    Ambulatory Operations DirectorAt Cross Country Healthcare, we are seeking a highly skilled Ambulatory Operations Director to join our team. As a key member of our Women's Services department, you will be responsible for executing strategic plans, overseeing daily operations, and ensuring efficient workflow across one or more ambulatory clinics or units. This...

  • Director of Operations

    3 weeks ago

    Reston, Virginia, United States Austin Ear, Nose & Throat Clinic Full time

    About the Role:We are seeking a highly experienced and skilled Director of Operations to join our team at Austin Ear, Nose & Throat Clinic. As a key member of our leadership team, you will be responsible for providing strategic leadership and direction to our clinical operations, ensuring the highest level of patient care and satisfaction.Key...

  • Licensed Clinical Director

    3 weeks ago

    Reston, Virginia, United States HealthCare Recruiters International Full time

    Job Title: Licensed Clinical DirectorHealthCare Recruiters International (HCRI) is seeking a dynamic and experienced Licensed Clinical Director to lead our team in Northern California.The ideal candidate will have a Master's degree, independent licensure (LPC, LMFT, LCSW), and at least 3 years of management experience in a forensic setting. They will be...

  • Operations Director

    2 weeks ago

    Reston, Virginia, United States Plastic Executive Recruiters Full time

    Director of Operations, PlasticsWe are seeking a seasoned Director of Operations with extensive experience in managing high-volume plastics plants. The ideal candidate will have a deep understanding of plastics processing, including injection molding, thermoforming, blow molding, films, or profile extrusion.This is a leadership role that requires a...

  • Clinical Research Site Director

    4 weeks ago

    Reston, Virginia, United States Medix™ Full time

    Site Manager Job DescriptionThe Site Manager plays a pivotal role in driving site operations to new heights by ensuring exceptional performance and alignment with company objectives. With a dual focus on satisfying both sponsor requirements and participant needs, this leader ensures that contractual obligations are met, swiftly resolves any operational...

  • Operations Director

    2 weeks ago

    Reston, Virginia, United States MANN+HUMMEL Full time

    MANN+HUMMEL is seeking a highly skilled Operations Director to lead our production plant. The ideal candidate will have a strong background in engineering and manufacturing, with a minimum of 5 years of experience in a similar role.Key Responsibilities:The Operations Director will be responsible for planning, managing, and coordinating all activities within...