Distinguished Scientist (Executive Director), Asset Development Team Leader

Job Description

The Executive Director has primary responsibility for the planning and directing clinical research activities involving new or marketed drugs for oncology indications. The Executive Director will manage and oversee the entire cycle of clinical development, including study design, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international meeting. They will provide internal scientific leadership for cross-functional areas supporting clinical trials and will interact externally with key opinion leaders.

Specifically, the Executive Director may be responsible for:

• Evaluating pre-clinical and translational work for the purpose of generating early clinical development plan and Investigational New Drug applications

• Developing clinical development strategies for investigational or marketed vaccines that incorporate the latest scientific developments, regulatory requirements, the competitive landscape, and commercial considerations

• Planning clinical trials (design, operational plans, settings) based on these clinical development strategies

• Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed vaccines

• 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

• Participation in internal and joint internal/ external research project teams relevant to the development of new compounds, and the further study of marketed compounds and support of business development assessments of external opportunities.

• The Executive Director may manage other Directors and/or Senior Directors responsible for oncology clinical development programs or projects. Mentoring and career development for direct reports (when applicable) will be a key function of the role.

• Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; and assist the Vice President in ensuring that appropriate corporate personnel is informed of the progress of studies of our company and competitors' drugs and internal and external expert opinion on scientific questions relevant to their areas of responsibility.

The Executive Director is responsible for maintaining a strong scientific fund of knowledge by: 

• Maintaining awareness of scientific developments within their area of expertise, in terms of new scientific findings, research methodologies 

• Identification of 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 their 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 their competency and to maintain awareness of research activities in their area of responsibility. 

To accomplish these goals, the Executive Director may: 

• Oversee authoring of detailed development documents, presentations, budgets, and position papers for internal and external audiences

• Manage a complex matrix of internal stakeholders within clinical development (i.e. across existing PDTs and TAs) and across functions 

• Facilitating 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. 

Education:

• Pharm.D.

• Clinical research training and experience required.

Required Experience and Skills:

• Minimum of 5 years of industry experience in drug development or biomedical research experience in academia or an equivalent combination of academic and industry experience.

• Minimum of 3 years of clinical and/or safety medicine experience

• Demonstrated record of scientific scholarship and achievement

• Understanding of full E2E drug development process and ideally candidate would have in-depth experience in early and/or late development.

• Has demonstrated success in being a critical team member for multiple studies and protocols

• Knowledge and ability to originate new program ideas and recommends expansion or curtailment of clinical trials on the basis of results and/or scientific information, including business development and in-licensing opportunities.