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Director, Clinical Research, Early Development - Oncology. Job in Upper Gwynedd, Pennsylvania, United States in Merck & Co., Inc.. Nelest.com
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Director, Clinical Research, Early Development - Oncology

col-narrow-left   

Job ID:

22162

Location:

Upper Gwynedd, PA 

Job function:

Research & Development
col-narrow-right   

Posted:

03.05.2016

Employment Type:

Full time

Industry:

Healthcare / Pharma
col-wide   

Title:

Director, Clinical Research, Early Development - Oncology

Job Description:

Description Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, 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. The Director reports to an Executive Director in the Early Oncology Clinical Research Group.Under the guidance of a supervisor, the Director has primary responsibility for the planning and directing early phase clinical research activities involving oncology medicines, including translational, phase I, and phase II studies. The Director will manage the entire space of early clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.

Specifically, the Director may be responsible for:
  • Working with preclinical colleagues to evaluate promising new targets
  • Evaluating pre-clinical and translational work for the purpose of generating early clinical development plan and Investigational New Drug applications,
  • Developing of clinical development strategies for investigational oncology drugs,
  • 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 oncology drugs,
  • Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as regulatory interactions such as new drug applications, clinical study reports,
  • Analyzing and summarizing the clinical findings from studies to support meeting presentations and publications
  • Participation in internal and joint internal/external research project teams relevant to the development of new compounds
  • Assist in evaluation of licensing or acquisition efforts related to early oncology compounds.
In executing these duties, the Director may:
  • Supervise the activities of 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 Senior/Executive Director in ensuring that appropriate Corporate personnel are informed of the progress of studies of Merck's and competitors' drugs and internal and external expert opinion on scientific questions relevant to his/her areas of responsibility.

The 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 Merck'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 Merck 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 may:
  • Author detailed development documents, presentations, budgets, and position papers for internal and external audiences,
  • Facilitating collaborations with external researchers around the world, and
  • Travel on company business to manage future or ongoing clinical research projects
Travel: Yes, 25 % of the Time Description Director, Clinical Research, Early Development - Oncology-CLI004561 Description Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, 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. The Director reports to an Executive Director in the Early Oncology Clinical Research Group.Under the guidance of a supervisor, the Director has primary responsibility for the planning and directing early phase clinical research activities involving oncology medicines, including translational, phase I, and phase II studies. The Director will manage the entire space of early clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.
Specifically, the Director may be responsible for:
  • Working with preclinical colleagues to evaluate promising new targets
  • Evaluating pre-clinical and translational work for the purpose of generating early clinical development plan and Investigational New Drug applications,
  • Developing of clinical development strategies for investigational oncology drugs,
  • 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 oncology drugs,
  • Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as regulatory interactions such as new drug applications, clinical study reports,
  • Analyzing and summarizing the clinical findings from studies to support meeting presentations and publications
  • Participation in internal and joint internal/external research project teams relevant to the development of new compounds
  • Assist in evaluation of licensing or acquisition efforts related to early oncology compounds.

Job Requirements:

Qualifications Position Qualifications:

  • M.D or M.D./Ph.D who is Board Certified or Eligible in Oncology
  • Must have experience in clinical trial development and execution,
  • 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


Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at staffingaadar@merck.com. Search Firm Representatives Please Read Carefully: Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means. Visa sponsorship is not available for this position. For more information about personal rights under Equal Employment Opportunity, visit: EEOC Poster EEOC GINA Supplement? Merck is an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.

Zip Code:

19446

Company Info
Merck & Co., Inc.

Kenilworth, NJ, United States

Phone:
Web Site: merck.com

Company Profile

Company Info


Merck & Co., Inc.
Kenilworth, NJ, United States
Phone:
Web Site: merck.com

Director, Clinical Research, Early Development - Oncology

col-narrow-left   

Job ID:

22162

Location:

Upper Gwynedd, PA 

Job function:

Research & Development
col-narrow-right   

Posted:

03.05.2016

Employment Type:

Full time

Industry:

Healthcare / Pharma
col-wide   

Title:

Director, Clinical Research, Early Development - Oncology

Job Description:

Description Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, 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. The Director reports to an Executive Director in the Early Oncology Clinical Research Group.Under the guidance of a supervisor, the Director has primary responsibility for the planning and directing early phase clinical research activities involving oncology medicines, including translational, phase I, and phase II studies. The Director will manage the entire space of early clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.

Specifically, the Director may be responsible for:
  • Working with preclinical colleagues to evaluate promising new targets
  • Evaluating pre-clinical and translational work for the purpose of generating early clinical development plan and Investigational New Drug applications,
  • Developing of clinical development strategies for investigational oncology drugs,
  • 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 oncology drugs,
  • Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as regulatory interactions such as new drug applications, clinical study reports,
  • Analyzing and summarizing the clinical findings from studies to support meeting presentations and publications
  • Participation in internal and joint internal/external research project teams relevant to the development of new compounds
  • Assist in evaluation of licensing or acquisition efforts related to early oncology compounds.
In executing these duties, the Director may:
  • Supervise the activities of 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 Senior/Executive Director in ensuring that appropriate Corporate personnel are informed of the progress of studies of Merck's and competitors' drugs and internal and external expert opinion on scientific questions relevant to his/her areas of responsibility.

The 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 Merck'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 Merck 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 may:
  • Author detailed development documents, presentations, budgets, and position papers for internal and external audiences,
  • Facilitating collaborations with external researchers around the world, and
  • Travel on company business to manage future or ongoing clinical research projects
Travel: Yes, 25 % of the Time Description Director, Clinical Research, Early Development - Oncology-CLI004561 Description Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, 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. The Director reports to an Executive Director in the Early Oncology Clinical Research Group.Under the guidance of a supervisor, the Director has primary responsibility for the planning and directing early phase clinical research activities involving oncology medicines, including translational, phase I, and phase II studies. The Director will manage the entire space of early clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.
Specifically, the Director may be responsible for:
  • Working with preclinical colleagues to evaluate promising new targets
  • Evaluating pre-clinical and translational work for the purpose of generating early clinical development plan and Investigational New Drug applications,
  • Developing of clinical development strategies for investigational oncology drugs,
  • 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 oncology drugs,
  • Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as regulatory interactions such as new drug applications, clinical study reports,
  • Analyzing and summarizing the clinical findings from studies to support meeting presentations and publications
  • Participation in internal and joint internal/external research project teams relevant to the development of new compounds
  • Assist in evaluation of licensing or acquisition efforts related to early oncology compounds.

Job Requirements:

Qualifications Position Qualifications:

  • M.D or M.D./Ph.D who is Board Certified or Eligible in Oncology
  • Must have experience in clinical trial development and execution,
  • 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


Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at staffingaadar@merck.com. Search Firm Representatives Please Read Carefully: Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means. Visa sponsorship is not available for this position. For more information about personal rights under Equal Employment Opportunity, visit: EEOC Poster EEOC GINA Supplement? Merck is an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.

Zip Code:

19446
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