Director, Clinical Operations
The Director, Clinical Operations will be responsible for setting up the infrastructure for the conduct of Disc Medicine’s clinical trials and managing their execution. Disc Medicine currently has 2 clinical-stage programs.
The candidate should have extensive experience managing all operational aspects of the conduct of clinical trials via contract research organizations and investigator-initiated studies in accordance with CFR, EMA, and ICH GCP regulations in support of regulatory authority submissions. The candidate will also serve as the clinical operations representative in cross-functional project teams. Associate Director and Senior Director levels will also be considered, commensurate with qualifications.
- Responsible and accountable for overseeing the planning and execution of clinical trials.
- Oversee, lead, and manage cross-functional team resources and external service providers (including clinical operations, medical monitoring, safety, data management, auditors, and consultants) to conduct trials on time, on budget, in compliance and of highest quality.
- Coordinate and oversee execution of all operational aspects of clinical studies (including identification and management of vendors, availability of clinical supplies at the sites, review and approval of request for investigational test articles).
- Work collaboratively with cross functional internal and external teams including translational research and development, regulatory affairs, medical writing, biostatistics and program management.
- Lead the process and oversee execution for the identification, qualify, audit and management of all external vendors and CROs.
- Ensure clinical trial team and clinical trial sites are properly trained and in compliance with company and/or CRO SOPs, CFR/EMA regulations, ICH GCP guidance and study protocol.
- Identify, qualify, manage, and maintain relations with clinical trial sites, including collaborating with Principal Investigators and field team on developing robust study protocols, drive site selection, and patient recruitment programs that deliver enrollment targets. Perform site monitoring with field team, as needed.
- Facilitate all start-up activities including but not limited to investigational site contracts, investigational site, and ethics committee submissions.
- Responsible for writing, reviewing, coordinating finalization (and approving when appropriate) clinical project deliverables such as scope definition documents, investigational product labeling/kitting, Pharmacy Manuals, informed consent, IRB submissions/approvals, site activations, monitoring plan and tools, CRFs, DMP, edit checks, safety plan, DMC charter, close-out plans and CSRs.
- Assist with the development of presentations, handouts, and coordination of Investigator Meetings.
- Drive site selection and patient recruitment programs that deliver enrollment targets.
- Responsible for ensuring the trial is “audit ready” at all times.
- Work with appropriate team members to ensure that all TMF-related documentation is current, on-file at respective site, CRO, and sponsor locations throughout trial conduct.
- Notify and assist with preparation of internal project team for regulatory agency audit and address any audit observations appropriately and in a timely manner.
- Perform oversight of trial to ensure that safety concerns and/or adverse events/SAEs are properly tracked and reported.
- Provide regular updates to management team, vendors and contract staff concerning.
- status and progress of the trial.
- Manage each project within agreed upon timelines.
- Collaborate with program management and scientific leaders to identify, communicate and address challenges of drug development programs.
BA or BS degree required in science/health-related field.
- The candidate must have a minimum of 7 years of clinical research and/or clinical project management experience in clinical trials; experience with clinical trials world-wide is a plus.
- Excellent working knowledge of ICH GCP guidelines, CFR, EMA, and HIPAA regulations.
- Demonstrated ability to work independently but within the project team structure to operationalize and move the clinical trials forward.
- Excellent written and oral communication; effective presentation skills and sufficient computer skills.
- Ability to operate effectively within a matrix team setting in start-up biotechnology.
- Ability to prioritize tasks and resources, meet deadlines and seamlessly adapt to changing priorities.
- Possess strong and leadership skills with proven ability to work within a project team structure, lead internal and external team members at all levels.
ABOUT DISC MEDICINE:
The people at Disc Medicine are dedicated to the discovery and development of novel therapies to transform the lives of patients who suffer from hematologic diseases. Disc Medicine is led by a seasoned, collaborative team of scientists and industry experts committed to innovative programs that advance the frontiers of medicine. Disc Medicine values transparency, authentic communication, and scientific rigor and promotes a company culture in which differences are celebrated and all individuals are valued.
Interested in joining our team? Please contact us at email@example.com
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