Associate Director Clinical R&D

Associate Director - Clinical Strategy & Development

New Jersey (Hybrid)

$150,000 - $175,000

Job Description

We are looking for an experienced clinical development leader to contribute to the advancement of innovative drug programs, including 505(b)(2) submissions and complex generics. This role involves close collaboration with cross-functional teams to shape and execute clinical strategies that support both internal R&D and external partnerships.

Key Responsibilities

• Evaluate new product opportunities from a clinical development perspective, focusing on regulatory and scientific feasibility.
• Lead the design and execution of clinical trials across all phases, ensuring alignment with regulatory standards and scientific objectives.
• Develop comprehensive pharmacokinetic (PK) and clinical plans, ensuring compliance with GCP, GLP, and evolving regulatory expectations.
• Monitor regulatory guidance updates and integrate changes into clinical development strategies.
• Identify and address gaps in early-stage development that could affect downstream clinical timelines.
• Prepare clinical documentation for regulatory submissions, including pediatric study plans and briefing materials for agency meetings.
• Collaborate with regulatory affairs to support FDA interactions and ensure alignment with submission strategies.
• Provide scientific input on formulation development, including PK modeling, simulation, and IVIVC/IVIVR methodologies.
• Support business development by evaluating clinical aspects of in-licensing opportunities and due diligence assessments.
• Work cross-functionally to align clinical study designs with corporate goals and regulatory requirements.

Qualifications

• Ph.D. (preferred) or Master's degree in a scientific field with a minimum of 10 years of experience in clinical research and development.
• Demonstrated experience in 505(b)(2) product development and clinical trial execution.
• Background in specialty or generic pharmaceuticals, with exposure to various dosage forms such as inhaled, topical, and injectable products.
• Strong expertise in clinical pharmacology, including modeling and simulation tools (e.g., WinNonlin).
• Familiarity with CNS or psychiatric therapeutic areas is a plus.
• In-depth knowledge of clinical development processes, regulatory frameworks (GCP, GLP, ICH), and submission strategies.
• Excellent communication, leadership, and cross-functional collaboration skills