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Merck

Makes medicines, vaccines and animal treatments

Distinguished Scientist - Multiple Teams

Clinical Research OperationsUpdated on Nov 11
Full-time

About the Job

Requirements

  • M.D. or M.D./Ph.D. required.
  • Industry experience in Thoracic Oncology is required.
  • At least 3 years of clinical medicine experience are required.
  • At least 5 years of industry experience in drug development are required.
  • A demonstrated record of scientific scholarship and achievement is required.
  • A proven track record in clinical medicine and a background in biomedical research are required.
  • Strong interpersonal skills and the ability to function in a team environment are required.
  • Required skills include clinical development, clinical judgment, clinical medicine, clinical research, clinical trial planning, clinical trials, cross-cultural awareness, cross-functional teamwork, drug development, ethical standards, medical research, oncology, pulmonology, regulatory requirements, research methodologies, scientific consulting, scientific leadership, scientific research, and strategic leadership.

Responsibilities

  • Plan and direct clinical research activities involving new or marketed drugs in Oncology Clinical Research and Thoracic Oncology.
  • Manage the full clinical development cycle, including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international meetings.
  • Provide internal scientific leadership for cross-functional areas supporting clinical trials and interact externally with key opinion leaders.
  • Evaluate pre-clinical and translational work to develop early clinical development plans and Investigational New Drug applications.
  • Develop clinical development strategies for investigational or marketed agents, incorporating scientific developments, regulatory requirements, the competitive landscape, and commercial considerations.
  • Plan clinical trials, including their design, operational plans, and settings, based on clinical development strategies.
  • Monitor and manage the conduct of ongoing or new clinical trials for investigational or marketed agents.
  • Analyze and summarize clinical study findings to support safety and efficacy decisions, new drug applications, clinical study reports, and publications.
  • Participate in internal and joint internal/external research project teams for developing new compounds and further studying marketed compounds, and support business development assessments of external opportunities.
  • Provide support to other therapeutic areas on clinical issues related to oncology compounds.
  • Manage Directors and/or Senior Directors responsible for Oncology Global Clinical Development projects, as applicable.
  • Supervise clinical teams in executing clinical studies, as applicable.
  • Collaborate with the Section Head to promote the company's development strategy for the indication of interest.
  • Work with experts in commercialization, regulatory affairs, statistics, medical affairs, and manufacturing to manage clinical development projects.
  • Assist the Section Head in informing appropriate corporate personnel about study progress, competitors' drugs, and internal and external expert opinion on relevant scientific questions.
  • Maintain awareness of scientific developments, research methodologies, and new findings within the area of expertise.
  • Identify scientifically and operationally strong investigators to assist in developing investigational and marketed drugs.
  • Establish communication with prominent clinical investigators who can assist in evaluating the company's drugs.
  • Attend scientific meetings to maintain competency and awareness of research activities in the area of responsibility.
  • Author detailed development documents, presentations, budgets, and position papers for internal and external audiences, as applicable.
  • Facilitate collaborations with external researchers around the world, as applicable.
  • Travel on company business approximately 20% of the time to manage future or ongoing clinical research projects; the posting separately lists travel requirements of 25%.

Desired Qualifications

  • Board certification or eligibility in Oncology and/or Hematology is preferred.
  • Prior specific experience in clinical research and prior publication are preferred.

About the Company

Merck

Makes medicines, vaccines and animal treatments

Merck develops prescription medicines, vaccines and veterinary treatments for patients, health systems and animal owners worldwide. Its vaccine portfolio includes Gardasil 9, which helps prevent cancers and other diseases caused by several types of human papillomavirus. The company takes potential treatments through laboratory research and clinical trials, then manufactures and sells approved products to drug distributors, hospitals, physicians and governments. Its animal health division sells medicines and vaccines to veterinarians, farmers and pet owners, while selected drug partnerships also earn shared profits or royalties. Founded in 1891, Merck is headquartered in Rahway, New Jersey.

Company size
10,001+
Company stage
IPO
Headquarters
Rahway, NJ
Founded
1891

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