Senior Director, Clinical Development Operations

About Us:

Anvia Therapeutics is a dynamic and innovative biotech company dedicated to developing small molecule inhibitors targeted at treating inflammatory and autoimmune diseases.   We foster a collaborative environment where scientific excellence and creativity drive our mission to develop impactful medicines.

Overview

The Senior Director, Clinical Development Operations is responsible for providing strategic direction and operational excellence across all phases of clinical development programs. This key leadership role oversees the planning, execution, and oversight of clinical trials from early-phase through market filings, ensuring program objectives are achieved within established timelines, budgets, and quality standards. This position reports directly to the Chief Executive Officer.

Essential Responsibilities

Strategy & Leadership

• Ensures clinical trial objectives are aligned with clinical development strategy and overall corporate strategy.
• Generates progress reports and presents clinical program strategy and status updates to Senior Management.
• Contributes to business development activities and represents Development Operations on project and management teams.

Clinical Operations & Execution

• Directs the planning and execution of clinical trials across all phases of development, from early development through NDA/regulatory submissions.
• Accountable for clinical program and study timelines, budgets, and managing actual spend to approved budgets, including tracking actuals and communicating deviations.
• Oversees quality and risk management of clinical development programs, ensuring adherence to SOPs, GCP, ICH guidelines, and FDA regulations.
• Oversees the development and implementation of clinical trial systems and workflows (e.g., IRT/IXRS, central lab, eCOA) including design, specifications, and UAT.
• Oversees clinical supply forecasting, labeling/packaging, distribution, and chain of custody for clinical supplies.

Vendor & External Partner Management

• Oversees full-service CRO and vendor management activities, including RFP, vendor selection, scope of work development, performance management, and vendor governance.
• Works with internal and external medical, scientific, and operational experts to maintain awareness of industry standards and best practices.

Regulatory & Scientific Contributions

• Authors and/or contributes to regulatory documentation and filings (e.g., IB, IMPD, IND) and correspondence with regulatory authorities and ethics committees.
• Contributes to the writing, review, and finalization of clinical study protocols, Investigator Brochures, and clinical study reports.
• Contributes to scientific publications and presentations.

People & Team Development

• Provides leadership, mentorship, and direction to the Clinical Development Operations team; responsible for recruiting, developing, training, and retaining top talent.
• Ensures prioritization of activities and resourcing is aligned with clinical development program needs.
• Develops and maintains company SOPs, work instructions, and training for Clinical Operations activities.
• Constructively manages conflict within development teams and ensures timely resolution of issues.
• Fosters a collaborative, highly integrated, and innovative team culture.

Qualifications

• BA/BS in life sciences or a health-related field required
• Minimum 12+ years of progressive clinical operations and/or development operations experience within the pharmaceutical or biotechnology industry.
• Demonstrated experience  in clinical development programs and teams spanning early to late phase clinical development
• 5+ years of people management and leadership experience with a proven track record of building and developing high-performing teams.
• Demonstrated working knowledge of ICH/GCP guidelines, data management, clinical systems, statistical programming, medical writing, pharmacokinetics/pharmacodynamics, protocol design, and drug product development and distribution.
• Experience with global project teams and ability to work across multiple time zones and languages preferred.
• Proficiency with MS Office Suite (Word, Excel, PowerPoint, Outlook, Project).
• Highly adaptable with the ability to thrive in a fast-paced, start-up or clinical-stage environment and develop creative solutions with limited infrastructure.
• Excellent interpersonal skills with strong oral and written communication abilities.
• Innovative, analytical, and highly organized with the ability to drive multiple projects to completion simultaneously.
• Proven experience working at the senior management level and recognized as a strong leader in a high-science organization.
• Willingness to travel up to 30%, as needed, to support clinical development programs.

The salary range for this position is $200,000-$260,000 per year.  The actual compensation offered will be based on factors such as relevant experience, education, and skills. In addition to base salary, we offer a comprehensive benefits package, including health insurance, paid time off, and retirement plan options.

Our employment decisions are based on merit, qualifications, and business needs. We are committed to providing a work environment free from discrimination, harassment, and retaliation, and we undertake affirmative action efforts to promote equal opportunity for all employees and applicants.

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