Associate Scientific Director Clinical Development - Endocrinology

Overview

The Associate Scientific Director, Endocrinology, NA is a key role in the delivery and support of scientific activities required to support RRD's Medical Strategy for the endocrinology franchise, integrating scientific and clinical data into programs supporting medical affairs.

Essential Duties and Responsibilities

• Contributing to the Clinical Development plan, including identifying critical data gaps, defining evidence needs, and proposing data generation strategies.
• Supporting clinical trial protocol development as an endocrinology subject matter expert, providing scientific and clinical guidance for robust study design.
• Collaborating with evidence generation, clinical development, and clinical operations on design, execution, and interpretation of clinical trials in endocrinology.
• Supporting clinical development regulatory interactions with the FDA as endocrinology SME.
• Managing RRD's Investigator Sponsored Studies (ISS) process, including tracking applications, review, contracting, and scientific communications with funded PIs.
• Providing scientific feedback on PI outcomes communications and ensuring dissemination of clinically relevant findings.
• Supporting the overarching endocrinology medical and clinical strategy, including situation analyses, evidence needs, and key scientific messages.
• Managing development and review of clinical and scientific deliverables such as evidence summaries, medical/clinical education materials, and internal scientific training content.
• Planning, staffing, and reporting on scientific/medical congresses and meetings.
• Staffing the Medical Review Committee for the endocrinology franchise.
• Supporting clinical and scientific evaluation of new business opportunities, including business cases and life cycle management activities.

Education and Experience

• 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.
• Endocrinology and/or metabolism clinical development experience is strongly preferred.
• Pharmaceutical experience with a good knowledge of 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.
• Relationship management of multiple stakeholders, internally and externally, such as KOLs, networks, PAGs, CROs and others.

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%) and occasional international travel.