Senior Clinical Director, Hematology
About the role
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.
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 engaging with other functional areas in support of study execution
- Working closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects
- Assisting 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
- Providing 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
- Authoring detailed development documents, presentations, budgets, and position papers for internal and external audiences
- Facilitating collaborations with external researchers around the world
- Traveling on company business about twenty (20) percent of the time to manage future or ongoing clinical research projects
Education
M.D. or M.D./Ph.D.
Required Experience and Skills
- 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
Preferred Experience and Skills
- Board Certified or Eligible in Oncology, Hematology, or related discipline
- Prior specific experience in clinical research and prior publication
Required Skills
- Clinical Development
- Clinical Medicine
- Clinical Pathways
- Clinical Research Management
- Clinical Trial Development
- Data Analysis
- Ethical Standards
- Hematology
- Intellectual Curiosity
- Oncology
- Pathology
- Regulatory Affairs Compliance
- Regulatory Reporting
- Scientific Consulting
- Strategic Planning
Preferred Skills
- Current Employees apply HERE
- Current Contingent Workers apply HERE
Pay
The salary range for this role is $282,200.00 - $444,200.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
Benefits
We offer a comprehensive package of benefits. Available benefits include 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. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
Schedule
Remote, 1st - Day shift. Travel requirements: 25%.