Clinical Director, Oncology Early Development

About the role

The Clinical Director (Principal Scientist) has primary responsibility for planning and directing clinical research activities involving new or marketed medicines in the Early Oncology therapeutic area. Our company's Oncology medicines span all phases of clinical development (pre-clinical to post-licensure). The Clinical Director may manage the entire cycle of clinical development for their signed studies including study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.

Responsibilities

• Plan clinical trials (designing, collaborating on operational plans, etc.) based on the clinical development strategy.
• Provide medical oversight and overall conduct of ongoing or new clinical trials for investigational or marketed drugs.
• Analyze and summarize clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication.
• Participate in internal and joint internal/external research project teams relevant to the development of new compounds and the further study of marketed compounds.
• Support 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 team in ensuring that colleagues 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.
• Maintain a strong scientific fund of knowledge by:
  • Maintaining awareness of scientific developments within their area of expertise, including new scientific findings and research methodologies.
  • Identifying scientifically and operationally strong investigators who can assist in the development of investigational and marketed drugs.
  • Establishing communications with prominent clinical investigators in their field of interest.
  • Attending appropriate scientific meetings to maintain competency and awareness of research activities.
• 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 of clinical medicine experience.
• Minimum of 1 year of industry experience in drug development or biomedical research experience in academia.
• 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.
• Strong verbal and written communication and presentation skills.

Preferred Qualifications

• Board Certified or Eligible in Oncology or related discipline.
• Prior specific experience in clinical research and prior publications.

Skills

• Required: Clinical Development, Clinical Judgment, Clinical Research, Clinical Trials, Clinical Trial Support, Drug Discovery Research, Early Clinical Development, Oncology.
• Preferred: Current Employees.

Pay

The salary range for this role is $255,800.00 - $402,700.00. 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

• Travel on company business about 20% of the time.
• Flexible work arrangements: Hybrid.