Director or Associate Director, Clinical Operations
The Director or Associate Director, clinical operations will be responsible for setting up the virtual infrastructure for the conduct of Disc Medicine’s early stage clinical trials and managing their execution.
The candidate should have extensive experience managing all operational aspects of the conduct of clinical trials via contract research organizations 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.
- Responsible and accountable for overseeing the 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 contract research organizations (CRO)
- Ensure clinical trial team and clinical trial sites are properly trained and in compliance with company and/or CRO standard operating procedures (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 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, presentation skills and 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:
Disc Medicine is a start-up biotechnology company, formed as an Atlas Venture seed company in October of 2017 with the intent of discovering new medicines for hematological disorders with a specific focus on the discovery and development of novel therapies for the treatment of hematologic diseases. Disc Medicine is led by an experienced team of scientists and industry experts and is supported by a panel of advisors with a strong track record of discovering and developing new and innovative therapies.
Disc Medicine Completed a $50 Million Series A Financing led by Novo Holdings A/S along with Access Biotechnology and founding investor Atlas Venture.
Interested in joining our team? Please contact us at email@example.com
Associate Director, Project Manage…
The Project Manager is responsible for managing the resources, timelines and budgets for discovery and early translational programs at Disc Medicine.read more
Senior Scientist-Toxicology, Precl…
The Senior Project Toxicologist has extensive experience managing contract research organizations, conducting toxicology and safety pharmacology studies in s…read more
Head of Research
The Head of Research will be responsible for the strategic and scientific leadership of the research function at Disc Medicine, to design and execute externa…read more
Director or Associate Director, Cl…
The Director or Associate Director, clinical operations will be responsible for setting up the virtual infrastructure for the conduct of Disc Medicine’s ea…read more