Principal Scientist, Early Clinical Development, Respiratory Therapeutic Area

We have an exciting opportunity for a physician-scientist to join our group as a Principal Scientist (Clinical Director) in Translational Medicine/Early Clinical Development in the Respiratory Therapeutic Area, based in Boston, MA.

Translational Medicine at our Research Division is responsible for early clinical development of novel therapeutics, working in close collaboration with our discovery scientists and late-stage clinical researchers. The Respiratory Therapeutic Area specifically focuses on development in the respiratory system, including diseases of the airways, parenchyma, and pulmonary vasculature.

We are seeking a highly qualified physician-scientist with training in pulmonology and an established track record of scientific achievement, who desires a career in developing therapies for respiratory disease. Success depends on the integrity, knowledge, imagination, creativity, skill, diversity, and teamwork of the people in the group. To this end, we strive to create an environment of mutual respect, encouragement, and teamwork.

About the role

Candidates should have a strong background in basic, translational, and/or clinical research and a desire to work collaboratively across the organization between departments and therapeutic areas as part of a global team.

Responsibilities

• Work with basic science teams on specific diseases and therapeutic areas, providing clinical expertise for identification and validation of novel targets, including the design of preclinical and clinical experiments to validate targets and/or pathways, and leveraging this work for development of novel therapeutics.
• Work with cross-functional teams including discovery scientists, pharmacologists, toxicologists, and other specialists to advance novel therapeutics from preclinical development into clinical development.
• As a key member/leader of an early development team, collaborate with internal and external staff and scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations) for the design and execution of early clinical development strategy.
• Take a lead role in developing and executing clinical pharmacology studies for programs in all phases (I – IV) of development, including formulation or device changes, drug-drug interaction studies, and studies in special populations.
• Provide early phase/clinical pharmacology support for programs through the regulatory filing process including preparation of supportive documents and presentations.
• Develop and execute studies to validate established and novel clinical biomarkers, including blood/tissue sampling, imaging, electrophysiological, wearable devices, and behavioral responses to study biological activity in humans.
• Provide clinical and scientific expertise to assess internal and external opportunities for partnership.
• Engage with the broader internal and external scientific community in disease or therapeutic areas of interest, including via consultations with scientific/academic thought leaders, preparation of posters and publications, and attendance/presentation at conferences.
• Work broadly with key functions across the company at research sites around the world.

Translational Medicine is specifically responsible for:

• Contributing to the identification of novel targets by partnering with Discovery Sciences to bring a clinical perspective into the earliest stages of target identification and validation, and to execute clinical studies to evaluate the relevance of potential targets to human disease in order to justify full development.
• Leadership of the early clinical development strategy for novel therapeutic programs from the preclinical stage through Phase 1 studies of safety, tolerability, pharmacokinetics and pharmacodynamics, to Phase 2 studies demonstrating Proof-of-Concept and enabling Phase 3 clinical trials.
• Development of biomarker strategies through cross-functional teams that advance therapeutics from First-in-Human studies through clinical Proof-of-Concept, including experimental medicine studies to establish and/or validate biomarker platforms.
• Development and execution of clinical pharmacology strategies to support later stages of development through to worldwide regulatory applications.

Requirements

• Doctoral degree: MD or MD/PhD (or international equivalent) required.
• Experience in biomedical research, with a demonstrated record of scientific scholarship and achievement including scientific publications.
• Experience in clinical medicine including completion or anticipated completion of residency and fellowship training is required.
• Fellowship training and clinical board certification in Pulmonology or related discipline involving care of respiratory diseases (such as Allergy) is required.
• Strong interpersonal, writing, and presentation skills, as well as the ability to function in a team environment, are essential.
• Experience as an academic faculty member is preferred.
• Prior experience in the pharmaceutical industry is helpful but not required.

Skills

• Allergy and Immunology
• Asthma
• Biomedical Research
• Chronic Obstructive Pulmonary Disease (COPD)
• Clinical Development
• Clinical Medicine
• Clinical Research
• Clinical Trial Planning
• Cross-Functional Teamwork
• Pulmonary Disease Research
• Pulmonary Disorders
• Pulmonology
• Translational Research

Pay

The salary range for this role is $260,300.00 - $409,700.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. 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. Available benefits include 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: 25%
• Relocation: Domestic
• VISA Sponsorship: Yes