Senior Principal Scientist, Clinical Research, Antibacterials, Antifungals, CMV and Covid 19

About the role

The Senior Director has primary responsibility for protocol development and medical/scientific oversight of clinical research studies involving investigational or marketed drugs in the infectious diseases therapeutic area. The individual will participate in all phases of the clinical trial process (mainly Phase 2-3) including study design, medical monitoring, and medical/scientific interpretation of study analyses, regulatory reporting, and publication. The role involves applying an in-depth understanding of the disease under study and drug pharmacology to the infectious disease therapeutic area’s clinical development strategy and the implementation of short- and long-term research objectives. The Senior Director will provide internal scientific leadership for cross-functional areas supporting clinical development and external leadership through interaction with key scientific leaders.

Responsibilities

• Planning clinical trials (design, operational plans) based on the clinical development strategies for investigational or marketed infectious disease drugs.
• Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed infectious disease drugs.
• Analyzing and summarizing clinical findings from studies to support decisions regarding safety and efficacy, as well as new drug applications, clinical study reports, or publications.
• Participation in internal and joint internal/external research project teams relevant to the development of investigational drugs and the further study of marketed drugs.
• Developing clinical development strategies for investigational or marketed infectious disease drugs.
• Presenting study data and program strategic plans to internal governance committees for endorsement and key program milestones.
• Maintaining a strong scientific fund of knowledge by staying aware of scientific developments within the area of expertise, including new scientific findings and research methodologies.
• Establishing communications with prominent clinical investigators in the field of interest, particularly those who can assist in the development of the company's investigational and marketed drugs.
• Attending appropriate scientific meetings to maintain competency and awareness of research activities in the area of responsibility.
• Authoring detailed development documents and presentations for internal and external audiences.
• Authoring scientific publications.
• Facilitating collaborations with external researchers around the world.
• Travel on company business up to about 10% of the time to manage future or ongoing clinical research projects.

Requirements

• Industry experience in clinical research and drug development (at least 5 years).
• Demonstrated success in overseeing clinical studies and protocols.
• Demonstrated record of scientific scholarship and achievement.
• Experience in clinical medicine.
• Excellent communication skills, both verbal and written.
• Strong interpersonal skills, as well as the ability to function in a team environment and leadership experience.

Qualifications

• Education: M.D. or M.D./Ph.D., preferably with demonstrated expertise in infectious diseases.
• Eligibility for medical licensure and board certification desirable.

Preferred Background

• Background in infectious diseases clinical research and drug development.
• Prior experience with registrational trials and filing with major health authorities.

Skills

• Required: Clinical Development, Clinical Judgment, Clinical Research, Clinical Trial Development, Clinical Trials, Drug Development, Infectious Disease, Interdisciplinary Problem Solving, Scientific Leadership.
• Preferred: Prior experience in a similar leadership role.

Pay

The salary range for this role is $282,200.00 - $444,200.00. An employee’s position within the salary range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational 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, and compassionate and sick days.

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

Schedule

• Travel requirements: up to 10% of the time.
• Flexible work arrangements: Remote.

Employee Status: Regular