Senior Director, Clinical Development Metabolism (MASH)

Job Description

The Senior Director (Sr. Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed medicines in the Metabolism section of the Atherosclerosis & Metabolism therapeutic area, with a particular focus on MASH (Metabolic Dysfunction-Associated Steatohepatitis) and other obesity-related disorders. Our company's Atherosclerosis & Metabolism medicines span all phases of clinical development (pre-clinical to post-licensure). The Senior Director will manage the entire cycle of late-stage clinical development and studies, including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.

Specifically, the Senior Director May Be Responsible For:

• 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 the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication
• Participation in internal and joint internal/external research project teams relevant to the development of new compounds, and the further study of marketed compounds.
• Evaluating pre-clinical and translational work for the purpose of generating early clinical development plans and Investigational New Drug applications;
• Developing clinical development strategies for investigational or marketed drugs
• Support of business development assessments of external opportunities

The Senior Director May:

• Work closely with the 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; and assist the Executive Director and/or Associate Vice President in ensuring that appropriate Corporate personnel are informed of the progress of studies of our company and competitors' drugs, and of internal and external expert opinion on scientific questions relevant to his/her areas of responsibility.

The Senior Director is responsible for maintaining a strong scientific fund of knowledge by:

• Maintaining awareness of scientific developments within his/her 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 his/her particular field of interest, particularly those who will be willing and able to assist in the evaluation of our company's drugs
• Attending appropriate scientific meetings to maintain his or her competency and to maintain awareness of research activities in his/her area of responsibility.

To accomplish these goals, the Senior Director may:

• 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 twenty (20) percent of the time to manage future or ongoing clinical research projects.

Qualifications

Education

M.D or M.D./Ph.D.

Required

• Must have 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 experience in academia
• Demonstrated success in overseeing clinical studies and protocols
• Demonstrated record of scientific scholarship and achievement
• Proven track record in clinical medicine and background in biomedical research
• Strong interpersonal skills, as well as the ability to function in a team environment
• Outstanding verbal and written communication and presentation skills

Preferred

• Board Certified or Eligible in Endocrinology, Gastroenterology, Hepatology or related discipline

• Direct clinical research experience in MASH, with a preference for candidates who have designed, executed, or medically monitored Phase 2 or Phase 3 trials in metabolic liver diseases

Required Skills:

Preferred Skills:

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As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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The salary range for this role is

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.

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 https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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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. 

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Relocation:

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