Executive Director, Clinical Research, Immunology
Job Description New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.This role can based from Boston, Rahway, or Upper Gwynedd.Our Clinical Research team pushes the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.Our Clinical 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 Executive Director, Immunology Global Clinical Development has primary responsibility for strategic planning and directing clinical research activities for an investigational compound in multiple indications across Rheumatology, Gastroenterology and Dermatology. The Executive Director will manage a team of MDs and PhDs who will oversee and execute the entire cycle of clinical development, including study design, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international meeting. As the Product Development Team Chair, the Executive Director is expected to have an enterprise mindset and be able to lead the cross-functional team through multiple stages of decision-making and generation of overall asset strategy. Primary
Responsibilities:
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 the investigational compound that incorporate the latest scientific developments, regulatory requirements, competitive landscape, and commercial/market access considerations
Planning clinical trials (design, operational plans, settings) based on these clinical development strategies
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
Leading a cross-functional 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 their areas of responsibility.
Support of business development assessments of external opportunities.The 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 drugs in immunology
Establishing collaborative relationships with external experts in Rheumatology, Gastroenterology and Dermatology particularly those whose research focus and expertise can inform and assist the evaluation of the company's investigational 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 Executive Director may:
Oversee authoring of 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. Education:
M.D or M.D./Ph.D. with prior experience in designing and/or executing phase 2 or 3 clinical trials specifically in Immunology (Rheumatology, Gastroenterology or Dermatology) Required Experience and Skills:
Minimum of 3 years of clinical medicine experience
Minimum of 10 years of industry experience in drug development
Demonstrated record of scientific scholarship/achievement and ability to prioritize across and manage several complex clinical programs
Prior experience in managing/mentoring other MDs or PhDs
Strong interpersonal and leadership skills to successfully manage a cross functional team
Extensive knowledge of clinical trial methodology and regulatory and compliance requirements for clinical trial execution
Experience with global regulatory interactions (FDA/EMA) for immunology programsMDPHYSICIANJOBS#MDPhysicianjobsWe 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., 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 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 usand 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.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 NondiscriminationWe 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 anothers thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. Search Firm Representatives Please Read Carefully 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. Employee Status:
Regular Relocation:
Domestic VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1 Requisition ID:
R174575
Salary Range:
$200K -- $250K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Responsibilities:
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 the investigational compound that incorporate the latest scientific developments, regulatory requirements, competitive landscape, and commercial/market access considerations
Planning clinical trials (design, operational plans, settings) based on these clinical development strategies
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
Leading a cross-functional 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 their areas of responsibility.
Support of business development assessments of external opportunities.The 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 drugs in immunology
Establishing collaborative relationships with external experts in Rheumatology, Gastroenterology and Dermatology particularly those whose research focus and expertise can inform and assist the evaluation of the company's investigational 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 Executive Director may:
Oversee authoring of 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. Education:
M.D or M.D./Ph.D. with prior experience in designing and/or executing phase 2 or 3 clinical trials specifically in Immunology (Rheumatology, Gastroenterology or Dermatology) Required Experience and Skills:
Minimum of 3 years of clinical medicine experience
Minimum of 10 years of industry experience in drug development
Demonstrated record of scientific scholarship/achievement and ability to prioritize across and manage several complex clinical programs
Prior experience in managing/mentoring other MDs or PhDs
Strong interpersonal and leadership skills to successfully manage a cross functional team
Extensive knowledge of clinical trial methodology and regulatory and compliance requirements for clinical trial execution
Experience with global regulatory interactions (FDA/EMA) for immunology programsMDPHYSICIANJOBS#MDPhysicianjobsWe 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., 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 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 usand 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.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 NondiscriminationWe 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 anothers thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. Search Firm Representatives Please Read Carefully 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. Employee Status:
Regular Relocation:
Domestic VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1 Requisition ID:
R174575
Salary Range:
$200K -- $250K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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