Senior Director, Clinical Research, Cardiovascular and Respiratory

MSD•North Wales, PA

5d•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 [insert name of TA] therapeutic area. Our company's [insert name of TA] 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. Role Responsibilities: Specifically, the Senior Clinical Director may be responsible for: 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 [insert indication] 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 The Senior Director May: 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. 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
Outstanding verbal and written communication and presentation skills
Clinical Development
Clinical Judgment
Clinical Medicine
Clinical Research Management
Clinical Sciences
Clinical Trial Development
Clinical Trials
Collaborating
Drug Development
Leadership
Medical Research
Pharmaceuticals Marketing
Pulmonology
Regulatory Reporting
Scientific Publications

Nice To Haves

Board Certified or Eligible in [insert specialty] or related discipline
Prior specific experience in clinical research and prior publication
Current Employees apply HERE
Current Contingent Workers apply HERE

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 [insert indication] 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
Travel on company business about twenty (20) percent of the time to manage future or ongoing clinical research projects.