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

MSD • Rahway, NJ

1d • 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.

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

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.
• 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.
• Author detailed development documents, presentations, budgets, and position papers for internal and external audiences
• Facilitate 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
• Number of Employees: 5,001-10,000 employees