Senior Principal Scientist, Clinical Research, Immunology

Merck • North Wales, PA

15h • $282,200 - $444,200 • Hybrid

About The Position

The Senior Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research activities involving investigational compounds in Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle of clinical development, including determination of appropriate disease indications to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. The Senior Director may be responsible for evaluating pre-clinical and translational work for the purpose of generating the early clinical development plan and Investigational New Drug applications, providing clinical development support of business development assessments of external opportunities to grow the Immunology Pipeline, developing clinical development strategies for investigational drugs and 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 drugs, 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; and participation in internal and joint internal/external research project teams relevant to the development of new compounds. The Senior 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 Executive Director in ensuring that appropriate corporate personnel are informed of the progress of studies of our company and competitors' drugs and internal and external expert opinion on scientific questions relevant to his/her areas of responsibility. The Senior 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, Dermatology, and pulmonary disease, particularly those whose research focus and expertise can inform and assist the evaluation of the company's investigational drugs, and 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 Senior Director may author detailed development documents, presentations, budgets, and position papers for internal and external audiences, facilitate collaborations with external researchers around the world, and travel on company business about twenty (20) percent of the time to manage future or ongoing clinical research projects.

Requirements

• M.D., D.O., M.D./PhD, or D.O./PhD.
• Experience in the design and/or execution of phase 2 or 3 clinical trials specifically in Immunology (Rheumatology, Gastroenterology or Dermatology)
• 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
• Strong interpersonal skills, as well as the ability to work collaboratively in a cross-functional team environment.
• Clinical Development
• Clinical Medicine
• Clinical Research Management
• Clinical Studies
• Clinical Trial Development
• Clinical Trials
• Dermatology
• Drug Development
• Gastroenterology
• Inflammatory Bowel Diseases
• Pharmaceutical Industry
• Regulatory Compliance
• Rheumatology

Nice To Haves

• Preferred Skills: 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

• Strategic planning and directing clinical research activities involving investigational compounds in Immunology.
• Managing the entire cycle of clinical development, including determination of appropriate disease indications to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.
• Evaluating pre-clinical and translational work for the purpose of generating the early clinical development plan and Investigational New Drug applications.
• Providing clinical development support of business development assessments of external opportunities to grow the Immunology Pipeline.
• Developing clinical development strategies for investigational drugs and 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 drugs.
• 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.
• Participation in internal and joint internal/external research project teams relevant to the development of new compounds.
• Supervising the activities of Clinical Scientists in the execution of clinical studies.
• Working closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects.
• Assisting the Executive Director in ensuring that appropriate corporate personnel are informed of the progress of studies of our company and competitors' drugs and internal and external expert opinion on scientific questions relevant to his/her areas of responsibility.
• 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, Dermatology, and pulmonary disease.
• Attending appropriate scientific meetings to maintain his or her competency and to maintain awareness of research activities in his/her area of responsibility.
• Authoring 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: Senior
• Education Level: Ph.D. or professional degree