Senior Director, Clinical Operations & Evidence Generations, North America

This position is with Recordati Rare Diseases, Inc. (RRD), North America, an affiliate of Recordati.

Recordati Rare Diseases, Inc. (RRD) develops high-impact therapies for rare diseases, focusing on providing treatments to underserved communities in the U.S. Our mission is to mitigate the impact of rare diseases through increased awareness, better diagnoses, and improved treatment access in endocrinology, metabolic, hematology and oncology franchises. RRD is dedicated to fostering a dynamic work environment that promotes professional growth and a significant impact on patients' lives.

Reporting Structure

Reports To:    Chief Medical Officer and Vice-President Clinical Development, North America
Direct Reports:    Director HEOR, Director(s) Clinical Operations
Areas Managed:    Evidence Generation, RWE, HEOR, Clinical Development, Clinical Operations

Overview

The Senior Director of Clinical Operations for North America will play a strategic leadership role in shaping the direction, execution of clinical trials within the North American market and responsible for the evidence generation strategy for our rare disease portfolio. This individual will drive the development and execution of robust real-world evidence (RWE) and clinical evidence plans, ensuring the insights generated are aligned with regulatory, clinical, and market access requirements. The role requires a deep understanding of rare diseases, a collaborative mindset, and the ability to navigate complex cross-functional environments.

Essential Duties and Responsibilities

1.    Clinical Operations 

   •    Oversee the planning and execution of clinical trials, including phase IV, observational studies, and patient registries—ensuring timelines, budgets, and quality standards are met.
   •    Lead the development of clinical protocols, informed consents, and clinical study reports; ensure regulatory compliance and scientific integrity.
   •    Manage selection and oversight of Contract Research Organizations (CROs); monitor performance, timelines, and deliverables.
   •    Ensure alignment with Good Clinical Practice (GCP) guidelines and evolving regulatory requirements in North America.
   •    Collaborate with Quality Assurance and Global Clinical Operations to develop, review, and maintain SOPs reflecting best practices.
   •    Coordinate with the supply chain team to ensure clinical materials are delivered to sites as needed.
   •    Support issue resolution during trials; proactively address operational and compliance challenges.
   •    Partner with the Clinical Safety Lead on reconciliation processes and data accuracy in clinical trials.
   •    Provide oversight and compliance support for Investigator-sponsored studies, in collaboration with MSLs.

   2.    Evidence Generation

   •    Develop and lead the North America medical evidence generation strategy in alignment with corporate goals and stakeholder needs (regulators, payers, HCPs, patients).
   •    Prioritize and execute evidence generation initiatives in partnership with global medical affairs and R&D.
   •    Design and implement real-world evidence (RWE) strategies using EHRs, claims data, and registries to address rare disease population needs.
   •    Integrate insights from RWE and health economics/outcomes research (HEOR) into overall strategy.
   •    Apply innovative methodologies for generating both clinical and real-world data to fill evidence gaps and strengthen product value.
   •    Ensure evidence generation activities meet the needs of healthcare decision-makers and patient communities.
   •    Establish KPIs and regularly report progress to senior leadership.
   •    Engage with the Chief Medical Officer to ensure strategic alignment and uphold scientific rigor.

Education and Experience

•    A strong educational foundation in a relevant field such as medicine, pharmacy, or life sciences is essential.
•    Advanced degrees (e.g., MD, PhD, or PharmD) are required. MD is preferred, with a Oncology industry experience.
•    Extensive experience (18+ years) in evidence generation, clinical development, and real-world evidence (RWE) within the pharmaceutical or biotechnology industry is crucial. The candidate should have a proven track record of leading and managing clinical studies, including phase IV trials, observational studies, and patient registries.
•    The candidate must have a track record of strong collaboration skills, as working effectively with cross-functional teams, including medical affairs, regulatory affairs, market access, health economics, and commercial teams, is necessary. The candidate should also be knowledgeable and skilled in engaging with external stakeholders, such as key opinion leaders (KOLs), and patient advocacy groups.

Knowledge and Skills

•    Proven ability to lead and mentor a high-performing medical evidence team, providing clear direction and support to drive clinical study success.
•    Strategic thinker with experience developing and executing evidence generation plans aligned with corporate priorities and stakeholder needs.
•    Strong scientific and analytical skills to ensure study rigor, regulatory compliance, and efficient resource use.
•    Deep knowledge of North American regulatory and GCP requirements to maintain clinical and operational compliance.
•    Skilled communicator, capable of reporting outcomes to senior leadership and representing the organization in cross-functional forums.
•    Effective project manager with a track record of delivering trials on time, within budget, and at high quality.
•    Agile and resilient leader, able to maintain team focus and performance in dynamic, high-pressure environments.

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Based upon job requirements, employee may be required at times to attend meetings including travel out of state over weekends and nights. Employee must be able to freely operate and travel by car and train/plane modes of transportation. Employee is required to have a valid driver’s license and means of transportation.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be able to travel to clinical sites, domestic and international meetings.

This is a desk/sedentary role; however the employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms; talk and hear. Occasionally is required to lift and/or move light to moderate weight up to 25 lbs.

Location/Travel

•    This position is based at the RRD headquarters in Bridgewater, NJ
•    The position requires domestic travel (approximately 40%); occasional international travel.

FLSA Classification

•    This position is considered Exempt.

EEO Statement

It is the policy of Recordati Rare Diseases to provide equal employment opportunity (EEO) to all persons regardless of race, color, religion, sex, sexual orientation, gender identity, or national origin. Further, Recordati Rare Diseases will not discriminate on the basis of any characteristic protected by federal, state, or local law. Recordati Rare Diseases will provide reasonable accommodate for qualified individual with disabilities.

Disclaimer

This job description is not designed to cover or contain a comprehensive listing of the activities, duties or responsibilities that may be required.