Clinical Research Director, Immunology & Trials Strategy

Regulatory Jobs; Rahway (NJ); Hybrid; USD 256,000 - 403,000; Full time

Benefits offered by this job

Medical insurance

401(k) plan

Paid time off

Job summary

Merck & Co., Inc. in Rahway, NJ seeks a Clinical Director (Principal Scientist) to lead strategic clinical development for investigational immunology compounds, focusing on late-stage programs.

You will define disease indications, study designs, execution, analysis, regulatory filings, and publications. You will supervise Clinical Scientists, collaborate with cross-functional teams in regulatory, statistics, and manufacturing, and ensure progress is communicated to senior leadership.

Qualifications

• Minimum of 5 years of clinical and/or development experience (academia, clinical medicine, and/or corporate clinical development).
• Demonstrated record of scientific scholarship and achievement
• Prior experience in design and execution of phase 2 or 3 clinical trials in rheumatologic diseases is preferred
• Strong interpersonal skills, as well as the ability to work collaboratively in a cross-functional team environment

Responsibilities

• Evaluating pre-clinical and translational work for the purpose of generating the early clinical development plan and Investigational New Drug applications.
• Providing clinical development support of business development assessments of external opportunities to grow the Immunology Pipeline
• Developing clinical development strategies for investigational drugs and planning clinical trials (design, operational plans, settings) based on these clinical development strategies
• Monitoring and managing the conduct of ongoing or new clinical trials for investigational drugs
• Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication; and
• Participation in internal and joint internal/external research project teams relevant to the development of new compounds
• Supervise the activities of Clinical Scientists in the execution of clinical studies; work with cross-functional teams to manage projects; keep stakeholders informed; assist leadership in progress reporting

Skills

Clinical Development

Clinical Research

Clinical Trial Planning

Cross-Functional Teamwork

Immunology

Rheumatology

Education

M.D., D.O., M.D./Ph.D, or D.O./Ph.D.

Job description

Merck & Co., Inc. in Rahway, NJ seeks a Clinical Director (Principal Scientist) to lead strategic clinical development for investigational immunology compounds, focusing on late-stage programs.

You will define disease indications, study designs, execution, analysis, regulatory filings, and publications. You will supervise Clinical Scientists, collaborate with cross-functional teams in regulatory, statistics, and manufacturing, and ensure progress is communicated to senior leadership.