Senior Medical Director, Clinical Development

Essential Duties And Responsibilities

• Support the establishment of clinical trial strategies for oncology products in development.
• Design, prepare and initiate study protocols and other required documentation in compliance with project plans, federal regulations, GCP and good medical practice.
• Act as medical monitor for company sponsored trials (including but not limited to assessment of eligibility and safety events requiring study drug dose modification; data review; protocol writing; presentation at investigator meetings, steering committee meetings, DMC reviews; contributing to clinical study reports; publication review).
• Support project teams with therapeutic area specific information.
• Collaborate with internal safety group in analyzing and reporting of safety data from clinical trials.
• Analyze and interpret other clinical trial data and prepare reports for regulatory agencies and publication.
• Interact with key opinion leaders and investigators in relevant disease specific area.
• Ensure consistency of scientific and development strategies for oncology products in development.
• Maintain the highest level of scientific and clinical knowledge in relevant disease specific area.

Supervisory Responsibilities

• Directly supervise employees

Education/Experience

• MD (board certification or eligibility in Oncology or Hematology/Oncology desirable but not essential) and a minimum of 8 years post-residency relevant experience; or,
• Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job

• Minimum of eight years of drug development experience in biotechnology or pharmaceutical industry, or a combination of academia and industry. Note: Individuals with extensive academic clinical experience but without experience in the pharmaceutical industry may be considered.
• Hands-on experience in the design, execution, medical monitoring, and reporting of controlled clinical trials in oncology.
• Participation in clinical oncology studies with molecular targeted or immunological therapies.
• Understands basic science relevant to clinical oncology (biochemistry, immunology, molecular biology and/or genetics).

Knowledge/Skills

• Works effectively in a cross-functional/matrix environment
• Has broad expertise or unique knowledge and skills supporting contribution to development of company objectives and principles and effective achievement of goals.
• Develops technical and/or business solutions to complex problems.
• Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.
• Leads or manages the work of others by providing guidance to subordinates based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing.
• Ability to develop and maintain relationships with significant key opinion leaders.
• Communicates with strong interpersonal, influencing, and presentation (both written and verbal) communication skills
• Strong organizational and time management skills

Job Complexity

• Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors
• Works on abstract problems across functional areas of the business
• Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.
• May ensure budgets and schedules meet corporate requirements.
• Creates formal networks involving coordination among groups. Regularly interacts with executives and/or major customers.