Associate Director Clinical Operations

Associate Director, Clinical Operations
United States- Remote, up to 30% travel needed

$200,000 - $225,000 / yr + bonus + equity

We've partnered with one of the most innovative companies tackling alopecia today. Our client is a biotechnology company leading the way in regenerative medicine, developing breakthrough treatments that restore hair growth via precision therapies.

They are seeking an Associate Director of Clinical Operations to support late-stage alopecia trials. This is a rare opportunity at a growing biotech to play a key role in building and shaping clinical operations processes, while working closely with senior leadership to ensure successful trial execution.

Responsibilities:

• Drive and oversee all aspects of clinical studies from planning to close-out, ensuring adherence to timelines, budgets, and regulatory guidelines (FDA, EMA, GCP, ICH) using a risk-based approach.
• Develop and implement operational plans for clinical studies, managing CROs and vendors to ensure high-quality execution.
• Lead internal clinical trial team meetings, tracking key study metrics (e.g., enrollment, site feasibility, and data collection) to ensure progress and alignment with company goals.
• Partner with cross-functional teams (e.g., Clinical, Regulatory, Supply Chain) to support the strategic development and execution of clinical programs.
• Partner with cross-functional team and CRO to ensure patient recruitment and retention strategies are carried out effectively to facilitate on-time study enrollment.
• Ensure efficient database lock by overseeing monitoring plans and taking part in data review and reconciliation efforts.
• Contribute to the development and review of key regulatory documents (e.g., Protocol, Investigator Brochure, Clinical Study Report, Informed Consent Forms, patient-facing materials, and vendor plans).
• Assist in maintaining a quality-focused clinical infrastructure by developing, revising, and implementing SOPs to ensure operational consistency with GXP standards across trials and programs.
• Engage in the planning of quality assurance activities and coordinate remediation of audit findings.
• Lead vendor selection, contract/budget negotiation, and management (including RFP generation, review of SOWs, and Change Orders), serving as a point of escalation as needed.
• Develop and maintain project budget forecasts, ensuring efficient resource allocation, cost-effective execution, and punctual review of invoices.

Qualifications:

• Bachelor's degree in a life science, allied health field, or other relevant field (e.g. nursing, medical or laboratory technology).
• At least 9 years of relevant experience, including 5 years experience leading phase III studies
• Experience working in Alopecia and/or dermatology indications is preferred
• Proven ability to lead teams, manage projects, and solve complex problems.
• Strong communication skills, with the ability to persuade and influence partners in sensitive, high-impact situations.

If you feeel you are a good fit for the role and eager to join a collaborative, energetic and driven team; please don't hesitate to apply!