Senior Clinical Director, Clinical Research, Hematology

MSD•Boston, MA

1d•Hybrid

About The Position

The Senior Clinical Director (Senior Principal Scientist) has primary responsibility for planning and directing clinical research activities involving new or marketed medicines in the Oncology therapeutic area, specifically in our Hematology Section. Our company's Oncology medicines span all phases of clinical development (pre-clinical to post-licensure). 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.
Outstanding verbal and written communication and presentation skills.
Clinical Development
Clinical Development
Clinical Documentation
Clinical Judgment
Clinical Medicine
Clinical Reporting
Clinical Research Management
Clinical Trial Development
Clinical Trials
Data Analysis
Decision Making
Drug Development
Early Clinical Development
Ethical Standards
Hematology
Hemodialysis
Hemodynamic
Intellectual Curiosity
Interdisciplinary Problem Solving
Mentorship
Nephrology
Regulatory Affairs Compliance
Regulatory Compliance
Scientific Consulting
Scientific Publications

Nice To Haves

Board Certified or Eligible in Oncology, Hematology 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 or marketed Hematology 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 or marketed 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.
Participating in internal and joint internal/external research project teams relevant to the development of new compounds, and the further study of marketed compounds.
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.