Sr. Director, Clinical Operations

ANI Pharmaceuticals, Inc.; Princeton (NJ); On-site; USD 265,000 - 285,000; Full time

Benefits offered by this job

Health insurance

Retirement savings plans

Paid time off

Job summary

ANI Pharmaceuticals, Inc. seeks a Sr. Director of Clinical Development to provide strategic and operational leadership across all clinical functions, advancing the rare disease portfolio.

The role oversees Clinical Development for scientific quality, regulatory compliance, and trial execution on a global scale. Responsibilities include leading a high-performing team, aligning cross-functional partners, and ensuring studies meet timeline, budget, and quality requirements in collaboration with

Qualifications

• Advanced degree in clinical development or related field.
• Minimum 8 years in Clinical Development with 3+ in leadership.
• Experience leading Clinical Operations in pharma.
• Experience with rare disease, ophthalmology, or inflammation.
• Proven interaction with FDA and regulatory agencies.

Responsibilities

• Develop and execute integrated Clinical Development strategy.
• Lead and mentor Clinical Development team.
• Oversee global interventional and post-marketing studies (Phase 1–4).
• Ensure study design feasibility, data integrity, and timelines.

Skills

Strategic leadership

Cross-functional collaboration

Regulatory understanding

Budget management

Clinical operations oversight

FDA/pharma compliance

Education

MD/DO/PharmD/PhD

Tools

Regulatory compliance tools

Vendor management

Job description

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

Strategic Leadership

• Develop and execute an integrated Clinical Development 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.

Team Management & Development

• Lead, mentor, and develop high-performing Clinical Development 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.

Clinical Operations Oversight

• Lead and manage 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.

Cross-Functional & External Engagement

• 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.
• 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.

Qualifications / Requirements:

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

The base salary range for this position is$265,000-$285,000; the exact salary depends on various factors such as experience, skills, education, location, competencies and industry-specific knowledge.In addition to base salary, this position is eligible for participation in a competitive short term and long term incentive program based on performance and company results.

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.

Job Info

• Job Identification 1304
• Job Schedule Full time
• Locations 104 Carnegie Center Drive, Suite 300, Princeton, NJ, 08540, US