4:59 NewCo, a 5AM Ventures Company · 1 day ago
Director/Senior Director, Clinical Operations
United States
Full-time
Remote
Director/Executive
$200K/yr - $260K/yr
10+ years exp5AM Ventures is a clinical-stage biopharmaceutical company specializing in the development of novel long-acting therapeutics for obesity and related metabolic disorders. The Director/Senior Director, Clinical Operations will manage and oversee clinical studies, ensuring compliance with timelines, budgets, and regulatory standards while leading cross-functional efforts in clinical development.
Biotechnology
Responsibilities
Responsible for the clinical operation function at the company and for representing clinical operations in cross-functional program teams, working closely with team leaders and other functional area subject matter experts
Accountable for the strategic planning and operational execution of clinical trials, ensuring they are conducted within agreed upon timelines, budgets, and regulatory quality standards
Actively lead and/or participate in the development of clinical documents, including but not limited to protocols, ICFs, study manuals, investigator brochures, and clinical study reports
Responsible for maintaining constructive interactions with clinical sites to ensure that all trials and programs have clearly defined plans, strategies, and milestones
Actively lead the selection, management, and performance of study-related CROs, vendors, and external consultants
Accountable for the management of clinical budgets
Develop and maintain strong collaboration and communication with internal and external stakeholders, including regular communication of study-related metrics / KPIs to executive management and cross-functional study teams
Promote a strong quality culture within Clinical Operations, ensuring clinical trials are conducted according to ICH/GCP requirements, corporate/departmental SOPs/policies, and industry best practices. Participates and/or leads continuous improvement initiatives and collaborates in the development of Clinical Operations Standard Operating Procedures (SOP), Work Instructions (WI), training, and other tools to ensure compliance with FDA Regulations
Lead responses to any audits as required (site, internal file, process, and regulatory agencies)
Develop and execute resourcing plans to ensure adequate and appropriate monitoring of all trials, including the evaluation and implementation of clinical technologies (e.g., EDC, eTMF, CTMS) appropriate for the company’s stage of growth
Collaborate closely with CMC and Supply Chain teams to ensure clinical trial material (CTM) availability, stability, and proper handling/administration at clinical sites
Provide accurate, current updates to executive management and program teams regarding the status of clinical trials
Qualification
Required
Bachelor's degree or higher in a relevant field, preferably related to biological or life sciences. Higher/professional degree a plus
10+ years Clinical Operations experience
Strong experience in the set-up and management of domestic and international early and late phase clinical trials, either directly or via CRO/vendor management
Prior experience in metabolic, endocrine, or obesity clinical trials is highly desirable
Experience managing multiple projects and priorities
Strong working knowledge of GCP/ICH guidelines
Experience developing and managing departmental and study budgets and timelines
Strong interpersonal skills with demonstrated ability to effectively work with internal and external cross-functional groups
Extensive knowledge of drug development functions relevant to clinical trial conduct (e.g., data management, biostatistics, pharmacovigilance, CMC/supply chain management, etc.)
Demonstrated ability to collaborate effectively in cross-functional teams and function effectively in a lean, fast-paced biotech environment, balancing strategic leadership with daily tactical execution
Excellent written, communication, and interpersonal skills, and demonstrated cultural agility
Ability and willingness to travel domestically and internationally as needed, such as for study site visits
Benefits
Performance bonuses
Equity participation
Comprehensive health benefits
Company
4:59 NewCo, a 5AM Ventures Company
4:59 is a hands-on internal effort of 5AM Ventures to discover, incubate, and fund breakthrough science.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase