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Senior Director Clinical Research, Infectious Disease (Can be Remote) in Boston, Massachusetts

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.

Anti-infective drug development has been our core mission for over 80 years. Our Clinical Research group is at the forefront of global healthcare through research and innovation to combat established and emerging pathogens. Through clinical trials we ensure that our existing and pipeline products are developed to produce safe, effective, and innovative medicines, and we work with cross-functional colleagues in Global Medical and Scientific Affairs and Global Policy to ensure timely and equitable access to our medicines.

The Senior Director reports to an Executive Director in the Infectious Disease Clinical Research Group. Under the guidance of a supervisor, the Senior Director has primary responsibility for protocol development and medical/scientific oversight of clinical research studies involving new or marketed drugs in the infectious diseases therapeutic area. The individual would participate in all phases of clinical trial process (mainly Phase 2-5) including study design, medical monitoring, and medical/scientific interpretation of study analyses, regulatory reporting, and publication. The individual would apply an in-depth understanding of the disease under study and drug/vaccine pharmacology to the Infectious Disease therapeutic area’s clinical development strategy and the implementation of short and long-term research objectives. They would provide internal scientific leadership for cross-functional areas supporting clinical development and external leadership through interaction with key scientific leaders. In addition, a Senior Director may lead a Product Development Team, the cross-functional team responsible for end-to-end development and lifecycle management of new or marketed drugs, and will serve as the Clinical representative to this team.

Specifically, the Senior Director may be responsible for:

  • 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 infectious disease drugs

  • Planning clinical trials (design, operational plans) based on these clinical development strategies

  • Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed Infectious Disease 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.

  • Presenting study data and program strategic plans to internal governance committees for endorsement and key program milestones

In executing these duties, the Senior Director may:

  • Supervise the activities of Clinical Scientists or other Clinical Directors 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

  • Assist the Executive Director in ensuring that appropriate Corporate personnel are informed of the progress of studies of our company's and competitors' drugs and internal and external expert opinion on scientific questions relevant to their areas of responsibility

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

  • Maintaining awareness of scientific developments within their area of expertise, including new scientific findings and research methodologies

  • Establishing communications with prominent clinical investigators in their particular field of interest, particularly those scientifically and operationally strong investigators who can assist in the development of our company's investigational and marketed drugs

  • Attending appropriate scientific meetings to maintain their competency and to maintain awareness of research activities in their area of responsibility

To accomplish these goals, the Senior Director may:

  • Author detailed development documents and presentations for internal and external audiences

  • Author scientific publications

  • Facilitate 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

Education

  • M.D or M.D./Ph.D from a recognized school of medicine required, preferably with demonstrated expertise in Infectious Diseases subspecialty

  • Eligibility for medical licensure and board certification

  • Post graduate program yielding a PharmD degree with demonstrated expertise in clinical practice or clinical research may also be considered for the position

Required

  • At least three years industry experience in clinical research and drug development. Consideration will be given to candidates with relevant governmental/regulatory agency experience or faculty in academia with experience leading large-scale clinical research activities

  • Demonstrated record of scientific scholarship and achievement

  • Experience in clinical medicine and background in biomedical research

  • Excellent communication skills, both verbal and written

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

Preferred

  • Prior specific experience in clinical research

MDPhysicianjobs

#MDphysicianjobs

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 (https://survey.sogosurvey.com/Survey1.aspx?k=SsQYWYYQsQRsPsPsP&lang=0) to request this role’s pay range.

Under New York City 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:

$233,200.00 - $396,400.00

For positions located in the United States and Puerto Rico – Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) (“Customer-Facing Role”) who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/inst/1422$1533/rel-task/3001$14.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

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 (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

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

EEOC Poster (https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf)

EEOC GINA Supplement​

OFCCP EEO Supplement (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf)

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.

Under New York City 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:

$233,200.00 - $396,400.00

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:

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid, Remote Work

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID: R199348

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