17 Director, Clinical Operations Jobs in Gaithersburg, MD
Adaptive Phage Therapeutics is Hiring a Director, Clinical Operations Near Gaithersburg, MD
This role demands active leadership in all operational facets of clinical testing for groundbreaking biopharmaceutical drugs at a company deeply committed to enhancing patient outcomes. The incumbent will provide strategic leadership and operational guidance for all regulated clinical programs aimed at securing global marketing approval. This position requires a hands-on approach, with the opportunity to make a tangible impact on the lives of patients.
Essential Functions
- Support the planning and implementation of clinical training, ensuring ongoing oversight and continuous training throughout active clinical trials. Coordinate and manage all clinical operational activities across assignments.
- Lead and manage clinical operations staff, including external consultants and outsourced clinical research organization personnel responsible for clinical monitoring and data management of clinical trials. Ensure the delivery of high-quality operational results while maintaining consistency in processes and approaches.
- Assist in overseeing, drafting, and reviewing regulatory documents for submission to regulatory authorities, such as NDAs, INDs, annual reports, and responses to inquiries from regulatory authorities and institutional review boards/ethics committees.
- Define and oversee clinical trial plans across a range of infectious disease target areas.
- Manage Contract Research Organizations (CROs) effectively to ensure that clinical studies are conducted to the highest quality standards, delivered on time, and within budget. Take responsibility for clinical project timelines and budgets.
- Facilitate the completion of study-specific procedures and plans generated by CROs, partners, or BiomX.
- Collaborate effectively with cross-functional teams to ensure the timely delivery of clinical trial materials to clinical sites and contribute to the development of procedures for managing clinical samples for laboratory testing.
- Demonstrate a strong understanding of FDA and other regulatory authority requirements that impact clinical studies.
- Develop internal systems to ensure that clinical studies are conducted in compliance with current regulations and to prepare the company adequately for audits and inspections by government sponsors, FDA, and international regulatory authorities.
- Oversee the selection process for CROs, clinical trial sites, potential investigators, and external contractors. Monitor and evaluate clinical site performance as necessary.
- Oversee and contribute to the development of department Standard Operating Procedures (SOPs) to ensure that company policies and procedures align with current international regulations and guidelines.
- Ensure compliance with study plans through the review of data reports and outputs, including Key Performance Indicators (KPIs), identified risks, and trends using outputs from monitoring activities and functional groups, as applicable.
- Take responsibility for clinical quality management, including identifying quality issues, conducting root cause analysis, developing and executing Corrective and Preventive Actions (CAPAs), and managing risks in real time.
- Support the development, implementation, and improvement of appropriate and standardized processes, systems, and tools across the Clinical Operations function in collaboration with other relevant departments.
- Prepare and review Requests for Information (RFIs) and Requests for Proposals (RFPs) for clinical vendors, including CROs and consultants.
- Provide support for expedited Investigational New Drug (eIND) cases, if required, to ensure the timely delivery of life-saving phage treatment and appropriate data tracking.
- Monitor and manage the progress of clinical studies and deliver senior-level briefings to senior management.
- Participate in the review and development of clinical trial plans (e.g., Monitoring Plan, Blinding Plan, Project Management Plan, Data Management Plan, Risk Assessment and Mitigation Plans, etc.).
- Conduct periodic reviews of data listings and outputs from Electronic Data Capture (EDC) systems to address data quality or integrity issue
- Support Pharmacovigilance activities and safety reviews by ensuring the implementation of adequate SOPs, processes, and assessments to protect patient safety
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Competencies
- Demonstrates flexibility and adeptly manages multiple tasks to meet deadlines, consistently delivering high-quality work in a dynamic environment.
- Possesses an excellent working knowledge of ICH-GCP guidelines.
- Willing to engage in hands-on operational tasks as required by project demands.
- Exhibits strong presentation, documentation, and interpersonal skills, with a collaborative team-oriented approach.
- Displays strategic thinking with exceptional problem-solving and decision-making abilities.
- Proven self-starter capable of working independently and adapting quickly within a rapidly evolving environment.
- Exceptional communicator with robust interpersonal skills, capable of effective interaction with external contacts, including collaborators, partners, contract organizations, and internal stakeholders at all levels within the Company. Demonstrates strong team-building capabilities.
- High emotional intelligence with the capacity to contribute innovative ideas, influence others, and collaborate effectively both internally and externally.
- Builds and maintains positive relationships, earning the trust and confidence of colleagues to work effectively in a multidisciplinary project environment.
- Exhibits an open and transparent working style, excelling in prioritization and maintaining approachability, personability, and supportiveness.
- Demonstrates meticulous attention to detail, organization, and a consultative, flexible approach.
- Possesses strong business acumen and analytical skills.
- Has a solid understanding of human subject protections and oversight.
- Proficient in regulatory writing.
- Willingness and ability to travel domestically and internationally as needed.
- Other duties as needed.
In Office position
Travel required: Yes (Frequency if yes: 20%)
Education & ExperienceIdeally a postgraduate in life sciences with at least 15 years of experience in clinical research roles (operational or quality), preferably including both CRO and sponsor company experience
Significant experience related to the management and oversight of clinical studies at both early and late stage development
Preferably with biologics experience with a proven track record of successful delivery
Experience in GCP compliance with a strong understanding of FDA regulations, EU Clinical Trials directive, and / SOPs in pharmaceutical or biotech environment required
Experience in establishing Risk Management plans and strategies per ICH GCP E6 (R2)
Experience in managing CROs, clinical study vendors, and consultants.
Previous experience as a CRA and managing and leading CRA and monitoring activities
Complete knowledge of the drug development process and specific knowledge of clinical trial, clinical monitoring, and site management process, and associated industry regulations
Experienced working within growing and dynamic environments
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required for this job. Duties, responsibilities, & activities may change at any time with or without notice.
About the Organization BiomX (formerly Adaptive Phage Therapeutics) is a clinical-stage biotech dedicated to advancing therapies aimed at treating multi-drug resistant infections. Our mission is to tackle today's most challenging infections and those on the horizon. We are seeking driven and insightful individuals to join us in pursuing these goals.
EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.
Job Summary
Full Time
Pharmaceutical
$155k-213k (estimate)
05/24/2024
07/18/2024
aphage.com
GAITHERSBURG, MD
25 - 50
2016
GREG MERRIL
<$5M
Pharmaceutical
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About Adaptive Phage Therapeutics
Adaptive Phage Therapeutics (APT) is a clinical-stage company advancing therapies addressing multi-drug resistant infections. Prior antimicrobial therapeutic approaches have been fixed, while pathogens continue to evolve resistance to each of those therapeutics, causing those drug products to become rapidly less effective in commercial use as antimicrobial resistance (AMR) increases over time. APTs PhageBank approach leverages an ever-expanding library of bacteriophage (phage) that collectively provide evergreen broad spectrum and polymicrobial coverage. PhageBank phages are matched through a ...proprietary phage susceptibility assay that APT has teamed with Mayo Clinic Laboratories to commercialize on a global scale. APTs technology was originally developed by the biodefense program of U.S. Department of Defense. APT acquired the world-wide exclusive commercial rights in 2017. Under FDA emergency Investigational New Drug allowance, APT has provided investigational PhageBank therapy to treat more than 40 critically ill patients in which standard-of-care antibiotics had failed.
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