Senior Clinical Director, Oncology Early Development

MSD•Rahway, NJ

18d•Hybrid

About The Position

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Our Company has codified its legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Our Company is on a quest for cures and is committed to being the world's premier, most research-intensive biopharmaceutical company. Today, we're doubling down on this goal. Our R&D Laboratories are a true scientific research facility of tomorrow and will take our leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases. The Senior Director will report to an Associate Vice President in the Oncology Clinical Research Group. Under the guidance of a supervisor, the Senior Director has primary responsibility for the planning and directing of clinical research activities involving new or marketed Oncology medicines. Our Oncology medicines span all phases of clinical development (pre-clinical to post-licensure). The Senior Director will manage the entire cycle of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.

Requirements

M.D or M.D./Ph.D Required
Minimum of 3 years of clinical medicine experience
Minimum of 3 year of industry experience in drug development or biomedical research experience in academia
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.
Animal Vaccination
Animal Vaccination
Biological Field Work
Clinical Development
Clinical Documentation
Clinical Judgment
Clinical Medicine
Clinical Reporting
Clinical Research Management
Clinical Trial Development
Communication
Data Analysis
Decision Making
Drug Development
Ethical Standards
Evidence-Based Medicine
Global Health
Intellectual Curiosity
Interdisciplinary Problem Solving
Management Process
Medical Research
Mentorship
Plan of Action and Milestones (POA&M)
Regulatory Affairs Compliance
Regulatory Compliance

Responsibilities

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 participating in internal and joint internal/external research project teams relevant to the development of new compounds and the further study of marketed compounds.
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
Assist the Executive Director/AVP in ensuring that appropriate corporate personnel are informed of the progress of studies of our company's 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
Identifying scientifically and operationally strong investigators who can assist in the development of our 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 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
Travel on company business about twenty (20) percent of the time to manage future or ongoing clinical research projects.
Provide scientific and medical leadership for strategic alliances and Co-partnership opportunities
Support the team in prioritizing external collaborations.
Recognize and capitalize on opportunities to adapt direction in light of project successes and failures and market changes.
Manage selected opportunities, developing strategy and detailed milestones, measures, timelines and budgets to achieve designated value inflection points.
Identify, negotiate and maintain critical external partnerships.