Current jobs related to Director of Clinical Operations - Gaithersburg - Workforce Genetics

  • Clinical Operations Director

    4 weeks ago

    Gaithersburg, Maryland, United States GForce Life Sciences Full time

    Job Title: Clinical Operations ManagerJob Summary:The Clinical Operations Manager will play a critical role in the Clinical Operations function of Late Stage R&D, specifically focusing on BioPharmaceuticals and Oncology. This strategic position will oversee one or more clinical programs, including studies at various stages of development, with a particular...

  • Clinical Operations Manager

    1 month ago

    Gaithersburg, United States GForce Life Sciences Full time

    Duration: 12 months, contract-to-hire based on business needs and performancePosition Overview:The Global Clinical Operations Program Director (GPD) plays a critical role within the Clinical Operations function of Late Stage R&D, specifically focusing on BioPharmaceuticals and Oncology. This strategic position oversees one or more clinical programs,...

  • Senior Director Clinical Pathologist, Clinical Pharmacology and Safety Sciences

    4 weeks ago

    Gaithersburg, United States AstraZeneca Pharmaceuticals LP Company Full time

    Job Title: Senior Director Clinical Pathologist, Clinical Pharmacology and Safety SciencesIntroduction to role:Join our dedicated Research & Development team in Biopharmaceuticals R&D as a Senior Director Clinical Pathologist. This is your chance to make a meaningful impact on patients' lives! Reporting to the Global Head of Pathology, you will be integral...

  • Operations Director

    4 days ago

    Gaithersburg, Maryland, United States Wesco Full time

    Job SummaryAs the Director of Operations, you will oversee the performance of warehouse operations, including pick, pack, and ship for multiple site locations. This role requires strategic leadership to optimize established levels of business performance and KPI measuring to attain best-in-class results for on-time delivery, safety, quality control...

  • Director - Operations

    4 weeks ago

    Gaithersburg, United States WESCO Full time

    As the Director – Operations, you will be responsible for the performance of warehouse operations including pick, pack, and ship for multiple site locations. You will provide strategic leadership to optimize established levels of business performance and KPI measuring to attain best in class for on-time delivery, safety, quality control standards and...

  • Director of Facilities and Engineering Operations

    4 weeks ago

    Gaithersburg, Maryland, United States Joulé Full time

    Job Title:Director of Facilities and EngineeringLocation:Onsite at Gaithersburg, MarylandSchedule:Monday to Friday, 8:00 AM to 5:00 PMCompensation:Competitive salary, plus equity and other benefitsJob Type:Direct/PermanentJoulé is seeking a highly skilled and experienced Director of Facilities and Engineering to join our team. As a key member of our...

  • Executive Director of Operations

    2 months ago

    Gaithersburg, Maryland, United States iFLY, LLC Full time

    About the RoleiFLY, LLC is seeking a highly skilled and experienced Executive Director of Operations to lead our team in delivering exceptional customer experiences and driving business growth. As a key member of our leadership team, you will be responsible for developing and implementing strategies to enhance operational efficiency, improve customer...

  • Associate Director, Clinical Outcomes Assessment

    4 weeks ago

    Gaithersburg, United States AstraZeneca Full time

    Evinova is a health-tech business, accelerating the delivery of better health outcomes by propelling the life sciences sector forward in digital health, from the inside. Through our application of science-based expertise, evidence-led rigour, and human insight, our digital solutions are deliberately designed so that everyone can reach better health outcomes...

  • Director of Planning and Code Administration

    4 weeks ago

    Gaithersburg, Maryland, United States City of Gaithersburg Full time

    Job Title: Director of Planning and Code AdministrationJoin the City of Gaithersburg as we seek a highly skilled and experienced professional to lead our Planning and Code Administration Department. As the Director of Planning and Code Administration, you will be responsible for overseeing the management and operation of activities and programs in the...

  • Program Director

    4 weeks ago

    Gaithersburg, Maryland, United States Workforce Genetics Full time

    Job Title: Director/Senior Director Program/Portfolio ManagementAt Workforce Genetics, we are seeking a highly skilled and experienced Director/Senior Director Program/Portfolio Management to lead the strategic planning and execution of our portfolio of early-mid stage biotech programs.Key Responsibilities:Program Strategy and Governance: Develop and...

  • Program Director

    1 month ago

    Gaithersburg, Maryland, United States Workforce Genetics Full time

    Job Title: Director/Senior Director Program/Portfolio ManagementAt Workforce Genetics, we are seeking a highly experienced and skilled Director/Senior Director to lead our portfolio of early-mid stage biotech programs. This is a critical role in advancing our pipeline and achieving key milestones in the development of novel therapeutics.Key...

  • Biologics CMC Director

    2 weeks ago

    Gaithersburg, Maryland, United States Workforce Genetics Full time

    Job Title: Biologics CMC DirectorIntegerBio is seeking a highly experienced Biologics CMC Director to lead the development, scale-up, and manufacturing of clinical trial products for our early-stage biologic assets. As a key member of our scientific team, you will be responsible for managing the selection, start-up, and oversight of a CDMO partner to ensure...

  • CILA Program Director

    1 month ago

    Gaithersburg, Maryland, United States Covenant Ability Network of Illinois Full time

    Job SummaryCovenant Ability Network of Illinois is seeking a highly skilled and dedicated CILA QIDP to oversee the planning, development, coordination, monitoring, evaluation, and compliance of all program services for individuals residing in the CILAs and support staff.Key ResponsibilitiesCoordinate with the DSP Lead to ensure appropriate staffing coverage...

  • Operations Director

    2 weeks ago

    Gaithersburg, Maryland, United States At Home Stores LLC Full time

    Operations Lead Job DescriptionAt At Home Stores LLC, we are seeking a highly skilled and experienced Operations Lead to join our team. As an Operations Lead, you will play a critical role in ensuring the smooth operation of our stores, providing exceptional customer service, and driving sales growth.Key Responsibilities:Oversee store processes and...

  • Associate Director Study Leader, Cell Therapy

    5 months ago

    Gaithersburg, United States AstraZeneca Full time

    About AstraZeneca in Gaithersburg, MD: Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world. This campus employs more than 3,500 guides in our field and is only a short drive from Washington, DC. This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here, we play host to some of...

  • Operations Director

    1 month ago

    Gaithersburg, Maryland, United States Paul Davis Company Owned Store Full time

    Job Title: Operations ManagerJob Summary:We are seeking an experienced Operations Manager to join our team at Paul Davis Company Owned Store. As an Operations Manager, you will be responsible for coaching team members, recruiting new talent, and driving business growth. If you are a motivated and results-driven individual with a passion for leadership and...

  • Center Director

    2 weeks ago

    Gaithersburg, United States Learning Care Group Full time $65,000 - $68,000

    Our organization prides itself on excellence, putting the education and development of our children first and foremost. When you consider a career at Learning Care Group, know you will be joining a team that is passionate about thoroughly preparing their students for all the challenges that lie ahead. In a Director, we look for committed individuals who want...

  • Director of Cardiovascular Pathology

    4 weeks ago

    Gaithersburg, Maryland, United States ProClinical Full time

    Job Title: Director of Cardiovascular PathologyWe are seeking a highly skilled and experienced Director of Cardiovascular Pathology to join our team at ProClinical. As a key member of our pathology department, you will be responsible for providing comprehensive disease area, discovery, and toxicologic pathology support.Key Responsibilities:Provide expert...

  • Director/Senior Director Program/Portfolio Management

    3 months ago

    Gaithersburg, United States Workforce Genetics Full time

    Director/Senior Director Program/Portfolio Management:Lead the strategic planning and execution of our portfolio of early-mid stage biotech programs including the transition of assets from research into the clinic attending to scientific distinction, regulatory requirements and commercial potential in alignment with corporate goals. This role is critical to...

  • Preschool Center Director

    2 months ago

    Gaithersburg, United States Learning Care Group Full time $65,000 - $68,000

    Our organization prides itself on excellence, putting the education and development of our children first and foremost. When you consider a career at Learning Care Group, know you will be joining a team that is passionate about thoroughly preparing their students for all the challenges that lie ahead.In a Director, we look for committed individuals who want...

Director of Clinical Operations

2 months ago

Gaithersburg, United States Workforce Genetics Full time
Job DescriptionJob Description

Our client is a clinical-stage biotech dedicated to advancing therapies for multi-drug resistant infections. Our mission is to tackle today's most challenging infections and those on the horizon.

Role Overview: The Director of Clinical Operations will lead the design and implementation of clinical trials, focusing on combating bacterial infections, particularly multi-drug resistant pathogens. This role demands active leadership, strategic planning, and hands-on management to ensure trials are conducted efficiently within timelines and budgets, maintaining the highest quality standards.

Key Responsibilities:

  • Oversee clinical trial planning and execution.
  • Lead and manage clinical operations staff and external consultants.
  • Coordinate regulatory document submissions (NDAs, INDs, annual reports).
  • Manage CROs to ensure high-quality, timely, and budget-compliant studies.
  • Collaborate with cross-functional teams for trial material delivery.
  • Ensure compliance with FDA and international regulatory standards.
  • Develop and maintain SOPs and internal systems for clinical study compliance.
  • Conduct quality management, including CAPAs and risk management.
  • Support Pharmacovigilance activities and safety reviews.
  • Provide senior-level briefings and updates to management.

Requirements:

  • Postgraduate degree in life sciences.
  • 15+ years of clinical research experience, including CRO and sponsor roles.
  • Proven track record in GCP compliance and FDA regulations.
  • Experience in managing clinical studies and CROs.
  • Strong leadership, strategic thinking, and problem-solving skills.
  • Excellent communication and team-building abilities.
  • Willingness to travel domestically and internationally as needed.

Competencies:

  • Flexibility and multitasking in a dynamic environment.
  • Strong knowledge of ICH-GCP guidelines.
  • Hands-on approach to operational tasks.
  • Excellent presentation, documentation, and interpersonal skills.
  • High emotional intelligence and ability to build trust.
  • Strong business acumen and analytical skills.

Join Us: Be part of a team dedicated to making a tangible impact on patient outcomes. Apply now and contribute to our mission of combating multi-drug resistant infections.