Executive Director, Clinical Research, Neuroscience

Job Description

Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.

The Director or Senior/Executive Director has primary responsibility for the planning and directing clinical research activities involving new or marketed Neuroscience Medicines. Our company's Neuroscience Medicines span all phases of clinical development (pre-clinical to post-licensure). With a focus on late-stage development, the Director or Senior/Executive Director will manage the entire cycle of clinical development, including study design, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international meeting. He/she will provide internal scientific leadership for cross-functional areas supporting clinical trials and will interact externally with key opinion leaders.

Specifically, the Director or Senior/Executive Director May Be Responsible For:

• 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 Neuroscience drugs that incorporate the latest scientific developments, regulatory requirements, the competitive landscape, and commercial considerations;
• 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 Neuroscience 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; and
• Support of business development assessments of external opportunities.
• Provide support for other therapeutic areas regarding clinical issues related to Neuroscience.

The Director or Senior/Executive Director may:

• Supervise the activities of Clinical Scientists in the execution of clinical studies. Work closely with a cross-functional Senior/Executive Director group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; and assist the Vice President in ensuring that appropriate Corporate personnel is informed of the progress of studies of our company and competitors' drugs and internal and external expert opinion on scientific questions relevant to his/her areas of responsibility.

The Director or Senior/Executive 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, research methodologies
• Identification of 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 Director or Senior/Executive Director may:

• Author detailed development documents, presentations, budgets, and position papers for internal and external audiences
• Facilitating 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 senior faculty in academia
• Minimum of 3 years of clinical medicine experience
• Minimum of 3 (Director) or 5 (Senior/Executive Director) years of industry experience in drug development or biomedical research experience in academia
• Demonstrated record of scientific scholarship and achievement
• A proven track record in clinical medicine and background in biomedical research is essential
• Strong interpersonal skills, as well as the ability to function in a team environment, are essential.

Preferred

• Board Certified or Eligible in Neurology or Psychiatry
• 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.

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Who we are …

We are known as Merck & Co., Inc., Kenilworth, 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 …

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

Invent. Impact. Inspire.

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.

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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.

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Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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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Requisition ID:R125447