Senior Principal Scientist (Senior Director), Clinical Research, ADC

Merck • Rahway, NJ

14h • Hybrid

About The Position

The Senior Clinical Director (Senior Principal Scientist) has primary responsibility for planning and directing clinical research activities involving new medicines in the Oncology Asset therapeutic area. Our company's Oncology Asset TA medicines are generally in transition from early to late clinical development. The Senior Clinical Director may manage the entire cycle of clinical development for their assigned studies including study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.
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
Identifying 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 his/her particular 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 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
Travel on company business about twenty (20) percent of the time to manage future or ongoing clinical research projects.

Requirements

• M.D or M.D./Ph.D.
• Must have experience in industry or as senior faculty in academia
• Minimum of 3 years clinical medicine experience
• Minimum of 3 years of industry experience in drug development or biomedical research experience in academia
• Demonstrated success in overseeing clinical studies and protocols
• Demonstrated record of scientific scholarship and achievement
• Proven track record in clinical medicine and background in biomedical research
• Strong interpersonal skills, as well as the ability to function in a team environment
• Provide expert opinion, internally and externally, on relevant scientific questions within their responsibility.
• Antibody Drug Conjugates (ADC)
• Clinical Development
• Clinical Documentation
• Clinical Medicine
• Clinical Reporting
• Clinical Trial Development
• Clinical Trials
• Drug Development
• Ethical Standards
• Oncology
• Pharmaceutical Development
• Regulatory Compliance
• Regulatory Reporting
• Strategic Planning

Nice To Haves

• Board Certified or Eligible in Oncology or related discipline
• 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 plans and Investigational New Drug applications
• Developing clinical development strategies for investigational drugs
• Planning clinical trials (designing, collaborating on operational plans, etc.) based on the clinical development strategy
• Medical oversight and overall conduct of ongoing or new clinical trials for investigational drugs, including dose optimization studies
• 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
• Participating in internal and joint internal/external research project teams relevant to the development of new compounds
• Working with the tumor teams (PDTs) for the transition of new investigational drugs to registrational studies
• Supporting business development assessments of external opportunities
• Actively engage with other functional areas in support of study execution
• Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects
• Assist the Executive Director and/or Associate Vice President in ensuring that appropriate personnel are informed of the progress of studies of our company and competitors' drugs
• Provide expert opinion, internally and externally, on relevant scientific questions within their responsibility.

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees