Executive Medical Director, Clinical Development, Obesity

Regeneron Pharmaceuticals, Inc; Cambridge, Village of Tarrytown (MA, NY); On-site; USD 384,000 - 520,000; Full time

Job summary

An established industry player is seeking an Executive Medical Director for Clinical Sciences in Obesity. This pivotal role involves leading complex clinical studies and programs, ensuring drug safety, and driving clinical development strategies. The ideal candidate will have an MD or MD/PhD with extensive experience in clinical research and drug development, particularly in Endocrinology and Obesity. Join a diverse and inclusive culture that values innovation and offers comprehensive benefits, including wellness programs and equity awards. Take the next step in your career and make a significant impact in the field of clinical sciences.

Benefits

Health and wellness programs

Fitness centers

Equity awards

Annual bonuses

Paid time off

Qualifications

• Over 8 years of experience in clinical research or drug development.
• At least 6 years of people management experience in a matrix environment.

Responsibilities

• Leading the Global Clinical Subteam and managing clinical execution.
• Developing Clinical Development Plans for Phase I-III trials.

Skills

Clinical research

Drug development

People management

Interpersonal skills

Communication skills

Negotiation skills

Problem-solving skills

Regulatory knowledge

Endocrinology expertise

Cross-functional experience

Education

MD or MD/PhD

Job description

The Executive Medical Director, Clinical Sciences, Obesity is responsible for effectively executing large and/or complex studies and/or programs and serves as an expert resource to anticipate/resolve study/asset clinical and conduct issues. For assigned programs, the incumbent will serve as the Clinical Program Lead (CPL) for one or more compounds in multiple indications, driving broader cross-functional perspectives in the creation of clinical program development strategies. This role reports to the Internal Medicine Obesity CPL, Clinical Sciences, and also leads select Global Clinical Sub-Teams for the design, implementation, execution, and submission/approval of clinical development programs to support decision milestones and regulatory requirements. The role is a clinical subject matter expert for the CDU for assigned program(s)/asset(s).

A typical day may include:

• Leading the Global Clinical Subteam (GCST) and representing clinical development at the Strategic Program Team (SPT) for assigned assets, managing all clinical aspects and driving execution
• Developing and executing the Clinical Development Plan (CDP) for Phase I – III trials aimed at global registration
• Creating clinical components of key documents (regulatory documents, registration dossiers, etc.) supporting registration, market access, and commercialization
• Acting as medical expert and leader in stakeholder interactions
• Ensuring drug safety, including patient safety in clinical studies and signal detection from post-marketing surveillance, with support from Global Patient Safety
• Ensuring quality of all clinical documents (e.g., Investigator’s Brochure, protocol, study report, regulatory submission components, safety documents)
• Building and leading effective teams, managing activities of teams up to Senior Medical Director level, establishing objectives, and delegating tasks

This role may be suitable if you have:

• An MD or MD/PhD with over 8 years of experience in clinical research or drug development, including Phases I-IV; academic experience may be considered
• At least 6 years of people management experience, including in a matrix environment
• Strong management, interpersonal, communication, negotiation, and problem-solving skills
• Significant cross-functional experience and organizational awareness
• Expertise in Endocrinology, CV/Metabolism, and/or Obesity is strongly preferred
• Understanding of the global regulatory environment and approval processes
• Comprehensive knowledge of operational aspects of clinical trial conduct across all phases

#MDJOBSCD, #MDJOBS, #GDTherapeuticJobs

Interested in this opportunity? Apply now and take your first step towards living the Regeneron Way! We offer an inclusive, diverse culture with comprehensive benefits, which may include health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off, depending on location.

Regeneron is an equal opportunity employer. All qualified applicants will be considered without regard to race, color, religion, sex, nationality, ethnicity, civil status, age, citizenship, sexual orientation, disability, genetic information, familial status, marital or civil partnership status, pregnancy, gender identity, military or veteran status, or other protected characteristics. Reasonable accommodations are provided for known disabilities or chronic illnesses, unless undue hardship would result.

For U.S.-based roles, salary ranges are as per U.S. law; for roles in Japan and Canada, ranges are based on local laws and currency. Candidates outside these locations should consult with their recruiter regarding salaries and benefits.

Background checks are part of the recruitment process, conducted in accordance with local laws, to verify identity, right to work, educational qualifications, etc.

Salary Range (annually): $384,200.00 - $519,800.00