Senior Director, Clinical Operations (San Francisco)

Job Description

Job Description

Salary : $250k to $270k

ABOUT MEDICINES360

At Medicines360, we are more than a womens health innovation organization we are a catalyst for change. We are fearless in our pursuit of creative approaches to solving consequential womens health issues and transforming novel ideas into life-changing products that improve the lives of all women, and especially the underserved. We are fiercely dedicated to our mission of improving womens health worldwide. Our launched products address pressing health concerns of women, providing them with the products they need to live healthier, more fulfilled lives. For more information on Medicines360 please visit Medicines360.org

Position Title : Senior Director, Clinical Operations

Reports To : Interim Chief Medical Officer

FLSA Status : Full-time, Exempt

Location : San Francisco Hybrid

POSITION SUMMARY :

The Senior Director of Clinical Operations is a senior leader responsible for driving the successful planning, execution, and oversight of clinical trials across Medicines360s pipeline. This includes innovative medical device studies and a complex global observational study in maternal health.

Reporting to the Interim Chief Medical Officer, this role leads all aspects of clinical operations including study design input, vendor oversight, budget planning, and resource strategy, while ensuring high-quality, timely, and cost-effective execution. S / he may delegate some or all responsibilities of clinical trial oversight depending on scope of the trial to internal staff or external vendors while maintaining accountability for overall program performance. This individual will also mentor and supervise Clinical Operations staff or other team members assigned to studies, fostering a culture of quality and accountability.

ESSENTIAL DUTIES AND RESPONSIBILITIES :

• Leads the planning and execution of clinical trials across multiple concurrent programs, including pharmaceuticals, medical devices and diagnostic studies in womens health.
• Serves as the operational lead for strategic, cross-functional R&D initiatives, ensuring early alignment between clinical goals, timelines, and budgets.
• Oversees all aspects of clinical operations from study startup through close-out, including vendor selection, site management, and data oversight.
• Builds and optimizes internal infrastructure including SOPs, operational tools, and scalable processes to support organizational growth.
• Collaborates cross-functionally with Regulatory, Medical Affairs, Project Management, Finance, and external partners to ensure alignment across timelines, scope, and budget.
• Leads vendor selection and contracting processes, including development of requests for proposals (RFPs), bid review, and contract negotiation. Manages ongoing vendor relationships such as CROs, laboratories, and other service providers to ensure performance, quality, compliance, and cost-effectiveness throughout the study lifecycle.
• Develops and manages study budgets, working closely with Finance to ensure transparency, accuracy, and alignment with corporate goals.
• Identifies study risks and proactively implements mitigation strategies to ensure trial success.
• Oversees the development of study-related documentation including but not limited to Clinical Study Protocols, Investigators Brochures, Informed Consent Forms, and Clinical Study Reports, ensuring accuracy, consistency, and regulatory compliance.
• Ensures appropriate training of internal and external study team members to maintain compliance and operational consistency.
• Mentors and supervises clinical operations staff, supporting professional growth and contributing to strategic hiring decisions.
• Supports regulatory submissions and interactions, including the preparation of FDA and ex-US communications and study-related documentation.
• Contributes to the development of abstracts, presentations, and manuscripts for internal and external dissemination.
• Participates in the preparation of Clinical Study Reports, INDs, NDAs, 510k, PMAs and other clinical, regulatory, and safety-related documents.

ESSENTIAL SKILLS & QUALIFICATIONS :

• Bachelors degree or equivalent plus a minimum of ten years of clinical trials management experience, preferably within the women's health field (in-house pharmaceutical or biotechnology company experience desirable)
• Proven track record of leading clinical trials in medical devices, diagnostics, pharmaceuticals, or drug-device combination products, from initial planning and start-up through close-out and regulatory submissions
• Experience in womens health is preferred; maternal health and perinatal research experience is a significant plus
• Demonstrated success in vendor oversight, including CROs, laboratories, and other service providers, as well as in operational budget planning and management.
• Thorough knowledge of ICH-GCP, other relevant Guidance documents (from ICH, FDA, EMA etc.), and of regulations and requirements for clinical trial authorization
• Strong interpersonal skills and the ability to interact and build relations with physicians and vendors in a professional manner
• Outstanding written and verbal communication skills including proven ability to effectively collaborate with clinical study team, cross-functional team, and external parties in a rapidly growing environment
• Energetic, positive, flexible, and team-oriented
• Ability and willingness to travel up to 30% including international travel as required
• Demonstrates passion and enthusiasm for Medicines360s vision, and motivates, leads, and empowers others to achieve organizational goals
• Holds self and others accountable for results, demonstrates honesty, keeps commitments, works ethically and inspires an environment of trust, open communications, transparency, and collaboration
• Ability to build individuals and teams; rally them; motivate them, remove obstacles and empower employees to take ownership and utilize their skills, qualifications and experience to achieve the end deliverable
• Must integrate well with current team and other leadership team members within the organization
• Builds and maintains trust with other members in the workplace
• Excellent understanding and proficiency with Microsoft Office including strong MS Project skills and other project management software and standard Project Management tools and methodologies
• PMP certification desirable

IN OFFICE PRESENCE : Please refer to the Hybrid and Remote Work Guidelines for in-office presence. Current in office requirement is Tue, Wed, Thu each week.

PHYSICAL DEMANDS / MISC :

• Must be able to remain in a stationary position 50% of the time.
• The person in this position may need to occasionally move throughout the office to attend meetings in different rooms.
• Continuously operates a computer and occasionally uses other office productivity machinery, such as copy machines, and computer printer
• The ability to communicate information and ideas so others will understand. Must be able to exchange accurate information in these situations.
• The ability to observe details at close range (within a few feet of the observer)

Medicines360 is committed to a diverse workplace and is committed to equal opportunity employment for all job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, or veteran status. Medicines360 complies with all applicable local, state, and national laws governing nondiscrimination in employment.