Senior Director Clinical Research, NASH

Job Description

Our Company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity, and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement, and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

We are seeking a Growth and Improvement minded Senior Principal Scientist | Clinical Director that can help drive our Strategic Operating Priorities.

• Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs

• Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)

• Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape

• Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world

• Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success – They are a Competitive Advantage for Us

Summary, Focus and Purpose

The Director has primary responsibility for the planning and directing clinical research activities within the Diabetes, Endocrinology and Metabolism therapeutic area, with a particular focus on metabolic liver disease and non-alcoholic steatohepatitis (NASH). Our Company's research interest in NASH spans all phases of clinical development (pre-clinical to post-licensure). The Director will manage the entire cycle of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.

Key Responsibilities

• Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion

• Evaluating pre-clinical and translational work for the purpose of generating early clinical development plan and Investigational new drug applications

• Developing clinical development strategies for investigational or marketed drugs

• 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 or marketed 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 publication; and

• Participating in internal and joint internal/external research project teams relevant to the development of new compounds, and the further study of marketed compounds.

Duty Implementation

• Supervise the activities of Clinical Scientists in the execution of clinical studies

• Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects

• Obtain internal and external expert opinion on scientific questions relevant to areas of responsibility

Maintains Strong Scientific Fund of Knowledge

• Maintaining awareness of scientific developments within one’s area of expertise, in terms of new scientific findings and research methodologies

• Identifying scientifically and operationally strong investigators who can assist in the development of our company's investigational and marketed drugs

• Establishing communications with prominent clinical investigators in their particular fields of interest, particularly those who would be willing and able to assist in the evaluation of our company's drugs; and

• Attending appropriate scientific meetings to maintain one’s competency and awareness of research activities in areas of responsibility

Goal Accomplishment

• Author detailed development documents, presentations, budgets, and position papers for internal and external audiences

• Facilitate collaborations with external researchers around the world

• Travel on company business about 20% of the time to manage future or ongoing clinical research projects

Education

• M.D or M.D./Ph.D.

Required

• Demonstrated record of scientific scholarship and achievement

• Experience in clinical medicine and background in biomedical research

• Strong interpersonal skills, as well as the ability to function in a team environment

Preferred

• Five years clinical medicine experience

• Two years industry experience in drug development or biomedical research experience in academia

• Board Certified or Eligible Endocrinologist or Gastroenterologist (with expertise in Hepatology)

• Prior specific experience in clinical research and prior publication

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Who we are …

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Residents of Colorado

Click here to request this role’s pay range.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

U.S. Hybrid Work Model

Effective September 5,2023 our U.S. Hybrid work model will be as follows: 1. Three total days on site per week: Tuesday and Wednesday – plus one additional day of choice based on what works best for organizations and/or teams. 2. Fridays will formally be a remote-working day unless business critical tasks require onsite presence.

Under New York City, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected salary range:

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.

Learn more about your rights, including under California, Colorado and other US State Acts

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R210273