Oversees the direction, planning, execution, and interpretation of clinical trials/research and the data collection activities. Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports. May recruit clinical investigators and negotiates study design and costs. Responsible for directing human clinical trials, phases I IV for company products under development. Responsibilities also include adverse event reporting and safety responsibilities monitoring. Coordinates and develops reporting information for reports submitted to the FDA. Monitors adherence to protocols and determines study completion. May act as consultant/liaison with other corporations when working under licensing agreements.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Establish and communicate clinical trial strategies for high-quality early clinical decision making directed at highest value labels.
- Design, prepare and initiate study protocols and other required documentation in compliance with project plans, federal regulations, GCP and good medical practice.
- Research and select investigators.
- Analyze and interpret clinical trial data and prepare reports for FDA and publication.
- Work within the project team structure to help evaluate development candidate molecules.
- Act independently to determine methods and procedures on new assignments.
- Provide guidance, where required, and oversee the activities of other lower level personnel.
- Develop, influence and maintain relationships in the medical community with significant key opinion leaders.
- Supervise employees, both directly and indirectly through a dotted line structure or via other subordinate supervisors.
- MD degree with at least seven years experience in oncology clinical development, or related experience
- Equivalent combination of education and experience.
- May require certification in assigned area.
- Hands-on experience in the design and execution of controlled clinical trials in oncology..
- Has developed and overseen the implementation of registrational strategies in oncology.
- Understanding of basic science relevant to clinical oncology (biochemistry, immunology, molecular biology and/or genetics is desirable).
- Typically requires a minimum of 12+ years of related experience and/or combination of experience and education/training.
- Experience in Biotech/Pharmaceutical industry preferred.
- Ability to develop, influence and maintain relationships in the oncology community with significant key opinion leaders.
- Has extensive experience in relevant industry/profession.
- Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.
- Develops technical and/or business solutions to complex problems.
- Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.
- Guides the successful completion of major programs, projects and/or functions.
- Leads or manages the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing.
- Interprets, executes and recommends modifications to companywide policies and/or divisional programs. May establish organizational policies in a major segment of the company.
- Has complete understanding and wide application of technical principles, theories, concepts and techniques.
- Has extensive knowledge of other related disciplines.
- Applies strong analytical and business communication skills.
- Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles.
- If in a leadership role, works on complex issues where analysis of situations or data requires an in-depth knowledge of the company.
- Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.
- If in a leadership role, participates in corporate development of methods, techniques and evaluation criteria for projects, programs and people.
- Ensures budgets and schedules meet corporate requirements.
- Creates formal networks involving coordination among groups. Regularly interacts with executives and/or major customers.
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.