Associate Scientific Director Clinical Development - Endocrinology

About the role

At Recordati, we are united by a clear purpose: unlocking the full potential of life. With a century of history behind us, we are building the next chapter of our journey, continuing to grow while keeping patients at the centre of all we do. What drives us is a shared belief that health, and the opportunity to live life to the full, should be within reach for everyone. This brings energy to our work, shaping how we support each other and show up every day. Our values – Better Together, Never Settle and Always Deliver – reflect this mindset, helping us to keep improving and make a meaningful difference. Above all, these values bring to life our promise to everyone at Recordati, you can unlock your full potential. We know that people thrive when they can be themselves, are trusted and supported, and are given the opportunity to grow and make a meaningful contribution. Are you ready to unlock your full potential? 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.

Responsibilities

• 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.
• Working 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.

Requirements

• MD degree is preferred, doctorate is required, with documented experience in endocrinology or metabolic diseases.
• Strong scientific background with at least five years of clinical experience.
• Pharmaceutical experience with a good knowledge of the applicable regulations is required.

Qualifications

• Endocrinology and/or metabolism clinical development experience is strongly preferred.

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.

Benefits

• Health Insurance: Medical, dental, orthodontia, vision, life & ADD, short and long term disability insurance benefits.
• Retirement Benefits: 401k
• Paid Time Off: Vacation, holiday, and sick/personal time.
• Other Types of Pay: Annual bonus

Pay

Annualized Pay Range (Base Pay): $144,000 - $198,000

Schedule

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.