Director, Clinical Operations

Director, Clinical Operations

The Director of Clinical Operations will lead the translation of discovery findings into clinically and commercially viable products, with a focus on women's health devices. This role is pivotal in advancing projects from early research through clinical development, regulatory submission, and commercialization. They will be responsible for the successful planning, execution, and oversight of all aspects of clinical trials across Medicines360's pipeline, from early-stage feasibility studies to large pivotal studies.

Reporting to the CEO, this role leads all aspects of clinical operations, including study design input, protocol / CRF development, vendor selection and oversight, building relationships with KOLs, forming / leading scientific advisory boards, budget planning, and resource strategy, while ensuring high-quality, timely, and cost-effective execution. They may delegate some or all the responsibilities for clinical trial oversight, depending on the scope of the trial, to internal staff or external vendors, while maintaining accountability for overall program performance.

This role requires self-motivated individuals with a start-up, hands-on mentality and an innovative mindset for clinical design, execution, and management. They are expected to learn quickly and make logical, timely decisions to advance multiple clinical programs, with limited information.

Essential Duties And Responsibilities :

• Lead the clinical development of women's health devices and diagnostics from early feasibility stages through regulatory submission and commercialization.
• Drive cross-functional R&D initiatives, aligning clinical objectives, timelines, and budgets with overall program strategy.
• Oversee all aspects of study execution, including protocol development, site and vendor selection, contracting, implementing effective enrollment strategies, training, monitoring, and reporting to ensure high-quality, compliant, and timely results.
• Collaborate with biostatistics, data management, legal, and regulatory teams to ensure robust study design, effective data analysis plans, and compliant documentation.
• Manage external partners, including CROs, laboratories, and investigators, ensuring performance, issue resolution, and audit readiness.
• Develop and oversee study budgets in collaboration with Finance, ensuring transparency and alignment with corporate goals.
• Prepare for and support regulatory inspections and global submissions (e.g., FDA, MHRA).
• Build and maintain partnerships with external stakeholders and key opinion leaders; identify and integrate novel technologies to advance women's health innovation.
• Contribute to publications, presentations, and other scientific communications.
• Model Medicines360's mission and values by championing access, collaboration, and scientific integrity across all clinical programs.
• Strategic Leadership : Drive the clinical development of women's health devices and diagnostics from discovery to regulatory submission and commercialization.
• Serve as the operational lead for strategic, cross-functional R&D initiatives, ensuring early alignment between clinical goals and overall timelines and budgets.
• Responsible for the development of clinical study-related documentation, including but not limited to Clinical Study Protocols, Investigator Brochures, Informed Consents, and Clinical Study Records, ensuring accuracy, consistency, and regulatory compliance.
• Responsible for vendor selection and contracting process, including development of requests for proposals (RFPs), bid review, and contract negotiations.
• Responsible for clinical site selection and qualification.
• Works collaboratively with bioinformatics to develop Statistical Analysis Plans.
• In collaboration with cross-functional areas, develops the Data Management Plan for clinical studies.
• Responsible for securing IRB / EC approvals before starting clinical activities.
• In collaboration with Legal, responsible for negotiating and securing Clinical Trial Agreement before starting clinical activities.
• Oversee clinical study execution (both early-stage feasibility studies and extensive multi-centric clinical studies).
• Ensures appropriate training of internal and external study team members to maintain compliance and operational consistency.
• Set-up and ongoing management of vendor relationships for more complex outsourced studies, where appropriate (e.g., CROs, Drug depots, Labs, IVRS, IRB / ECs).
• Responsible for the resolution of vendor issues. Participates in internal / external audits of vendors / sites.
• Identifies risks within clinical studies and proactively plans a mitigation strategy.
• Develops and manages clinical budget, working closely with Finance to ensure transparency, accuracy, and alignment with corporate goals.
• Oversees development of Clinical Study Reports.
• Prepares internally and with clinical sites and CROs for regulatory inspections.
• Supports regulatory submissions for FDA, MHRA, and global market authorization.
• Partnership Management : Cultivate relationships with external partners, key opinion leaders.
• Innovation : Identify and integrate novel technologies in women's health products clinical testing.
• Participates in the development of abstracts, presentations and manuscripts for internal and external dissemination.
• Documentation : Ensure accurate, thorough, and timely research documentation, clinical study reports, and compliance with SOPs and industry standards.
• Mission Alignment : Champion Medicines360's mission to improve women's health and access to care globally.

Essential Skills & Qualifications :

Ability and willingness to travel up to 30% including international travel as required.

In Office Presence : Please refer to the Hybrid and Remote Work Guidelines for in-office presence. The current requirements are Tuesday, Wednesday, and Thursday each week.

Physical Demands / Misc :

Medicines360 is committed to a diverse workplace and to equal opportunity employment for all job applicants, regardless of race, color, religion, sex, sexual orientation, age, gender identity or expression, national origin, disability, or veteran status. Medicines360 complies with all applicable local, state, and national laws governing nondiscrimination in employment.