Associate Scientific Director Clinical Development - Endocrinology

Associate Scientific Director, Endocrinology, NA

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

The Associate Scientific Director, Endocrinology, NA (North America) is a key role in the delivery and support of many of the scientific activities required to support RRD's Medical Strategy for the endocrinology franchise such as integrating Recordati's scientific and clinical data into programs supporting medical affairs. They help interpret and communicate scientific topics, ensuring that scientific integrity and medical insights guide all their activities. They are involved in delivering almost all aspects of externally facing medical communications and serve as subject matter expert for other roles in medical affairs (MA).

Essential Duties and Responsibilities The Associate Scientific Director is directly responsible for delivering the following:

• Contributing to the Clinical Development plan, including identifying critical data gaps, defining evidence needs to support scientific objectives and key messages, and proposing data generation strategies that feed into the Scientific Data Evolution Plan.
• Supporting clinical trial protocol development as an endocrinology subject matter expert (SME), providing scientific and clinical guidance to ensure robust study design, methodological rigor, and alignment with clinical development objectives.
• Work collaboratively with evidence generation including clinical development and clinical operations on the design, execution, and interpretation of clinical trials in the endocrinology therapeutic area.
• Supporting clinical development regulatory interactions with the FDA, serving as the endocrinology SME providing scientific justification for study design, endpoints, and clinical rationale, and contributing to successful regulatory outcomes.
• Managing RRD's Investigator Sponsored Studies (ISS) process, including tracking received applications, managing the review process, tracking the contracting process and conducting ongoing scientific communications with funded Principal Investigators (PIs).
• Working with PIs that have completed their ISS to provide, at the PIs request, scientific feedback on their outcomes communications and ensure dissemination of clinically relevant findings across the RRD organization.
• Supporting the overarching endocrinology medical and clinical strategy such as situation analyses, identification of evidence needs, and development of key scientific messages to support Clinical Development and cross-functional alignment., all of which contribute to the tactical plans for the endocrinology franchise.

Education and Experience MD degree is required, with documented experience in endocrinology or metabolic diseases. Strong scientific background with at least five years of clinical experience. Endocrinology and/or metabolism clinical development experience is required. Pharmaceutical experience with a good knowledge of the applicable regulations is required.

Knowledge and Skills Proficiency in Microsoft Office suite, basic computer and typing skills, and tools/systems for managing clinical trials. Strong written and verbal English communication and presentation skills. Skilled at collaborating with stakeholders with varying viewpoints, influencing with and without authority, and negotiation. Includes relationship management of multiple stakeholders, internally and externally, such as KOLs, networks, PAGs (Patient Association Groups), CROs and others.

Work Environment This job operates in a professional office environment. Based upon job requirements, employee may be required at times to attend meetings including travel out of province 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 passport.

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 fly via a commercial air carrier. This is largely a sedentary role when working in office; 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 located at RRD HQ Office in Bridgewater, New Jersey with 3 days per week in the office as minimum expected. The position requires domestic travel (up to 30%); occasional international travel.

FLSA Classification This position is considered Exempt.

EEO Statement Recordati Rare Diseases values the diversity of its workforce and welcomes applications from all qualified applicants. 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, provincial, or municipal law. Recordati Rare Diseases will provide reasonable accommodation for qualified individuals 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.