Distinguished Scientist, Product Development Team Leader, Clinical Research - GI oncology

Merck • Rahway, NJ

8d • $310,900 - $489,400 • Hybrid

About The Position

Our Clinical Development teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs 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 Distinguished Scientist (Executive Director) and Product Development Team (PDT) lead, Oncology Global Clinical Development, has primary responsibility for the planning and directing clinical research activities involving new or marketed drugs in the Oncology Clinical Research group and in the field of GI cancers.
The Executive Director, PDT lead will manage the entire cycle of clinical development, including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international meeting. They will provide internal scientific leadership for cross-functional areas supporting clinical trials and will interact externally with key opinion leaders.

Requirements

• M.D or M.D./Ph.D.
• Must have experience in industry in the field of GI cancers
• Minimum of 3 years of clinical medicine experience
• Minimum of 5 years of industry experience in drug development
• 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.
• Clinical Development
• Clinical Trials
• Clinical Trials Monitoring
• Cross-Functional Teamwork
• Drug Development
• Gastrointestinal Cancer
• Leading Project Teams
• Oncology Trials
• Research Methodologies
• Results-Oriented
• Scientific Leadership
• Strategic Leadership

Nice To Haves

• Board Certified or Eligible in Oncology (and/or Hematology)
• Prior specific experience in clinical research and prior publication
• Current Employees apply HERE
• Current Contingent Workers apply HERE
• US and Puerto Rico Residents Only
• San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
• Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
• Search Firm Representatives Please Read Carefully
• Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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 place, introductions are position specific. Please, no phone calls or emails.

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 investigational or marketed agents 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 agents.
• 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 publications.
• 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 oncology compounds.
• Manage Directors and/or Senior Directors responsible for Oncology Global Clinical Development projects.
• Supervise the activities of entire Clinical Teams in the execution of clinical studies.
• Report and work collaboratively with the Associate Vice President to promote the development strategy of the company on the indication of interest.
• Work closely with a cross-functional Senior/ Executive Director group of experts in commercialization, regulatory affairs, statistics, medical affairs and manufacturing to manage clinical development projects; and assist the Associate 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.
• Maintaining awareness of scientific developments within their 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 their 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 their competency and to maintain awareness of research activities in their area of responsibility.
• Author detailed development documents, presentations, budgets, and position papers for internal and external audiences
• Facilitating collaborations with external researchers around the world

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: Ph.D. or professional degree