Sr. Director, Clinical Operations

ANI Pharmaceuticals • Princeton, NJ

4d • $265,000 - $285,000

About The Position

The Sr. Director, Clinical Operations provides strategic and operational leadership across all clinical functions to advance the company’s rare disease portfolio. This leader oversees Clinical Operations, ensuring scientific excellence, regulatory compliance, and operational effectiveness across clinical trials.

Requirements

• Strategic Medical Insight: Ability to define and drive integrated clinical strategies that align with company goals and patient needs.
• Cross-Functional Collaboration: Skilled in bridging scientific, clinical, and commercial functions to ensure cohesive planning and execution.
• Scientific & Clinical Expertise: Strong understanding of complex rare or inflammatory diseases and the ability to interpret and communicate clinical data.
• Operational Leadership: Proven track record of managing global studies with quality, compliance, and efficiency.
• Ethical & Regulatory Acumen: Thorough understanding of FDA, OIG, PhRMA, and GCP requirements.
• Project & Budget Management: Skilled in overseeing financial planning, vendor management, and contract review.
• Leadership Presence: Inspires high performance and collaboration across diverse teams in a dynamic environment.
• Advanced degree required: MD, DO, PharmD, or PhD; MD preferred.
• Minimum of 8 years of progressive experience in Clinical Development, with at least 3 years in leadership roles.
• Proven success in leading a Clinical Operations team within pharmaceutical organizations.
• Proven experience engaging with the FDA and other regulatory agencies, with a strong understanding of pharmacovigilance practices and requirements.
• Strong understanding of regulatory standards, ethical guidelines, and GCP principles.
• Exceptional communication and leadership skills, with the ability to influence across all organizational levels.
• Up to 25% travel required for role

Nice To Haves

• Experience in rare disease, ophthalmology, or inflammation therapeutic areas preferred.

Responsibilities

• Develop and execute an integrated Clinical Operations strategy that supports the company’s mission, product portfolio, and business objectives.
• Serve as a senior leader on the Medical Affairs leadership team,
• Partner cross-functionally with Regulatory, Pharmacovigilance, Commercial, Market Access, and Compliance to ensure alignment of clinical strategies.
• Champion a culture of scientific integrity, ethical compliance, and cross-functional collaboration.
• Lead, mentor, and develop high-performing Clinical Operations team.
• Foster collaboration, innovation, and continuous learning within and across functions.
• Ensure succession planning, talent development, and capability building to sustain organizational strength and future growth.
• Lead and manage the Clinical Operations and team responsible for global interventional and post-marketing studies (Phase 1–4, registries, RWE).
• Provide guidance on study design, operational feasibility, and data integrity to ensure successful trial execution.
• Oversee vendor management, CRO performance, and study governance.
• Ensure all clinical programs adhere to timelines, budgets, and GCP/regulatory requirements.
• Partner with Medical Affairs to integrate real-world evidence and post-marketing study outcomes into medical strategy.
• Serve as a key interface between Medical Affairs, Corporate, and Commercial teams to create strategic research plans that support corporate goals and scientific messaging.
• Engage with external experts, investigators, and professional societies to inform medical strategy and identify collaborative opportunities.
• Represent the company at scientific meetings, advisory boards, and industry events.
• Ensure ethical and compliant scientific exchange aligned with FDA, OIG, and PhRMA standards.

Benefits

• ANI Pharmaceuticals offers a variety of benefits to eligible employees, including health insurance coverage, life and disability insurance, retirement savings plans, paid leave programs, paid holidays and paid time off.
• Many of these benefits are subsidized or fully paid for by the company.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree