Merck Sharp & Dohme
AVP/Section Head, Metabolism - Global Clinical Development
Merck Sharp & Dohme, Rahway, New Jersey, us, 07065
Job Description
The Associate Vice President (AVP)/ Metabolism Section Head in the Atherosclerosis & Metabolism Therapeutic Area within Global Clinical Development will focus on driving strategy, development, and life-cycle management activities for assets and products for the treatment of metabolic disorders, with emphasis on obesity and obesity-related metabolic disorders including Metabolic Dysfunction-Associated Steatohepatitis (MASH).
The individual will be responsible for overseeing Product Development Team Leaders and Clinical Directors within their group to ensure successful execution of programs according to approved strategies and development plans, and to ensure optimal trial design and monitoring of studies, producing high-quality clinical documents and presentations. The position requires a solid understanding of the disease area, the functions and processes relevant to drug development, and project management principles applicable to the pharmaceutical industry.
Primary Responsibilities:
Leads late-stage development for multiple Metabolism projects, including pipeline candidates and licensed products
Supervises development of clinical documents including protocols, clinical study reports, and background documents for internal use or for submission to regulatory agencies
Interfaces with functional experts across the enterprise to ensure operational excellence in the late development of assets within the Metabolism Section of Global Clinical Development
May serve as a senior therapeutic area content expert within the company, providing input into research and business development priorities and prioritization of clinical assets
May serve as the senior liaison for relevant stakeholders in the external community (Scientific Leaders, Patient Community, Payers, Regulatory Agencies)
Responsible for managing, coaching, and mentoring Clinical Directors and developing the future talent pool
Education:
M.D or M.D./Ph.D.
Board Certified in Endocrinology, Diabetes & Metabolism; Obesity Medicine; or Gastroenterology preferred.
Required Experience and Skills:
Relevant industry experience bringing drugs and leading teams through various stages of clinical development, with emphasis on late-stage development
Experience with planning and execution of strategies for product registration, commercialization and life-cycle management
Strong leadership skills with a proven track record of hiring, mentoring, and retaining top talent
Demonstrated ability to collaborate and network well within the organization; widely recognized within the organization as an expert in metabolic disorders and drug development
Demonstrated ability to understand and manage, with appropriate support, the resources, time, and budgets for assigned projects; is business-savvy and results-oriented
Proven ability to analyze, recommend, and communicate scientific information and influence cross-functional team initiatives
Excellent written and oral communication skills
Strong interpersonal skills and executive presence to successfully engage with internal senior leaders and the external scientific community.
This is a US site-based role, which includes Rahway, NJ, Upper Gwynedd, PA and Boston, MA.
Employee Status:
Regular
Job Posting End Date:
11/16/2024
Requisition ID:
R319711
#J-18808-Ljbffr
The Associate Vice President (AVP)/ Metabolism Section Head in the Atherosclerosis & Metabolism Therapeutic Area within Global Clinical Development will focus on driving strategy, development, and life-cycle management activities for assets and products for the treatment of metabolic disorders, with emphasis on obesity and obesity-related metabolic disorders including Metabolic Dysfunction-Associated Steatohepatitis (MASH).
The individual will be responsible for overseeing Product Development Team Leaders and Clinical Directors within their group to ensure successful execution of programs according to approved strategies and development plans, and to ensure optimal trial design and monitoring of studies, producing high-quality clinical documents and presentations. The position requires a solid understanding of the disease area, the functions and processes relevant to drug development, and project management principles applicable to the pharmaceutical industry.
Primary Responsibilities:
Leads late-stage development for multiple Metabolism projects, including pipeline candidates and licensed products
Supervises development of clinical documents including protocols, clinical study reports, and background documents for internal use or for submission to regulatory agencies
Interfaces with functional experts across the enterprise to ensure operational excellence in the late development of assets within the Metabolism Section of Global Clinical Development
May serve as a senior therapeutic area content expert within the company, providing input into research and business development priorities and prioritization of clinical assets
May serve as the senior liaison for relevant stakeholders in the external community (Scientific Leaders, Patient Community, Payers, Regulatory Agencies)
Responsible for managing, coaching, and mentoring Clinical Directors and developing the future talent pool
Education:
M.D or M.D./Ph.D.
Board Certified in Endocrinology, Diabetes & Metabolism; Obesity Medicine; or Gastroenterology preferred.
Required Experience and Skills:
Relevant industry experience bringing drugs and leading teams through various stages of clinical development, with emphasis on late-stage development
Experience with planning and execution of strategies for product registration, commercialization and life-cycle management
Strong leadership skills with a proven track record of hiring, mentoring, and retaining top talent
Demonstrated ability to collaborate and network well within the organization; widely recognized within the organization as an expert in metabolic disorders and drug development
Demonstrated ability to understand and manage, with appropriate support, the resources, time, and budgets for assigned projects; is business-savvy and results-oriented
Proven ability to analyze, recommend, and communicate scientific information and influence cross-functional team initiatives
Excellent written and oral communication skills
Strong interpersonal skills and executive presence to successfully engage with internal senior leaders and the external scientific community.
This is a US site-based role, which includes Rahway, NJ, Upper Gwynedd, PA and Boston, MA.
Employee Status:
Regular
Job Posting End Date:
11/16/2024
Requisition ID:
R319711
#J-18808-Ljbffr