Senior Director, Clinical Development Metabolism (MASH)

Merck

Boston (MA)

On-site

USD 282,000 - 444,000

Full time

14 days+

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Job summary

Merck seeks a Senior Director (Sr. Principal Scientist) to plan and direct clinical research in Metabolism, with focus on MASH and obesity-related disorders across all development phases.

The Senior Director will drive strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting and publication. The role requires leading cross-functional teams, collaborating with Clinical Scientists, regulatory, statistics and manufacturing to advance our medicines and deliver

Qualifications

MD or MD/PhD required.
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.

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 drugs.
Analyze and summarize clinical findings to support safety/efficacy decisions and regulatory documents.
Participate in internal and joint research project teams for development of new compounds and marketed drugs.
Evaluate pre-clinical/translational work for early development plans and INDs; develop development strategies.

Skills

Cardiology

Clinical Development

Clinical Trials

Drug Development

Endocrinology

Hepatology

Liver Diseases

Nephrology

Obesity

Pharmaceutical Industry

Education

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

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

Cardiology, Clinical Development, Clinical Trials, Drug Development, Endocrinology, Hepatology, Liver Diseases, Nephrology, Obesity, Pharmaceutical Industry

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.

Requirements

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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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds.

The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

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The salary range for this role is

$282,200.00 - $444,200.00

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.

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.

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

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

Regular

Relocation

Domestic

VISA Sponsorship

Yes

Travel Requirements

25%

Flexible Work Arrangements

Not Applicable

Shift

Not Indicated