Senior Director, Clinical Research, Atherosclerosis

About the role

The Senior Director (Sr. Principal Scientist) is responsible for planning and directing clinical research activities involving new or marketed medicines in the Atherosclerosis section of the Atherosclerosis & Metabolism therapeutic area. This role oversees the entire cycle of late-stage clinical development and studies, including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.

Responsibilities

• Plan clinical trials (design, operational plans, settings) based on clinical development strategies.
• Monitor and manage the conduct of ongoing or new clinical trials for investigational or marketed Atherosclerosis drugs.
• Analyze and summarize clinical findings to support decisions regarding safety, efficacy, new drug applications, clinical study reports, or publications.
• Participate in internal and joint internal/external research project teams for the development of new compounds and further study of marketed compounds.
• Evaluate pre-clinical and translational work to generate early clinical development plans and Investigational New Drug applications.
• Develop clinical development strategies for investigational or marketed Atherosclerosis drugs.
• Support business development assessments of external opportunities.
• Work closely with Clinical Scientists in executing clinical studies and with cross-functional teams including commercialization, regulatory affairs, statistics, and manufacturing.
• Assist the Executive Director and/or Associate Vice President in keeping Corporate personnel informed about study progress and expert opinions on scientific questions.
• Maintain a strong scientific knowledge base by staying updated on new scientific findings and research methodologies.
• Identify and establish communications with prominent clinical investigators to assist in drug development.
• Attend scientific meetings to maintain competency and awareness of research activities.
• Author detailed development documents, presentations, budgets, and position papers for internal and external audiences.
• Facilitate collaborations with external researchers globally.
• Travel approximately 20% of the time to manage clinical research projects.

Qualifications

• M.D. or M.D./Ph.D. required.
• Experience in industry or as senior faculty in academia.
• Minimum of 3 years of experience in clinical medicine.
• Minimum of 3-5 years of industry experience in drug development or biomedical research in academia.
• Demonstrated success in overseeing Phase 2 and 3 clinical studies and protocols.
• Proven track record in clinical medicine and background in biomedical research.
• Strong interpersonal skills and ability to function in a team environment.
• Outstanding verbal and written communication and presentation skills.

Preferred qualifications:

• Board Certified or Eligible in Cardiology (adult or pediatric), Endocrinology, Nephrology, or related discipline.
• Prior specific experience in clinical research and publication.

Skills

Required skills:

• Atherosclerosis
• Cardiovascular Diseases
• Clinical Development
• Clinical Research
• Clinical Sciences
• Clinical Trials
• Cross-Functional Teamwork
• Drug Development
• Medical Monitoring
• Scientific Writing

Preferred skills:

• Current Employees apply through internal portal.

Pay

The salary range for this role is $173,200.00 - $272,600.00. An employee’s position within the salary range will be based on factors including relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Benefits

We offer a comprehensive package of benefits including:

• Medical, dental, vision healthcare, and other insurance benefits for employee and family.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, compassionate, and sick days.

More information about benefits is available at Merck Compensation and Benefits.

Schedule

• Travel requirements: 25%.
• Flexible work arrangements: Hybrid.