JOB SUMMARY

The Chief Scientific Officer provides scientific leadership within the Company. In conjunction with the commercial team, the CSO will initiate and enhance relationships with customers, participating in professional conferences, networking events, discovery calls, pre-award meetings, project team meetings, and bid defense meetings. In conjunction with clinical operations, the CSO is involved in establishing and maintaining relationships with investigator sites, engaging them to ensure they provide exceptional service in a compliant manner, and oversees the Company’s relationships with scientific advisors, key opinion leaders, and subject matter experts. The CSO is responsible for evaluation and refinement of written clinical trial protocols, clinical development program plans, clinical study reports, SOPs, work instructions, and business proposals. The CSO also takes on special project assignments, including but not limited to the Company’s placebo response program, rater training, and accelerator site program, and may also serve as an investigator or sub-investigator on clinical trial projects. The CSO provides educational support for the Company’s employees and sponsors, hosting in-service training sessions, courses, and webinars.

RESPONSIBILITIES

The essential functions of the CSO include:

• Lead the scientific activities of the Company, providing a scientific vision that aligns with the company's goals, represent the company in scientific forums, and serve as a thought leader.
• Support the development of the Company's strategic plan, identify new scientific opportunities, and help the executive team understand research timelines and feasibility.
• Provide scientific guidance, manage the scientific budget, and oversee daily scientific operations.
• Represent the Company and Company Interests with Senior Management and/or the commercial team during interactions with potential customers, investors, regulators and the scientific community.
• Develop and maintain effective science-related relationships with external partners, including sponsors, potential new customers, investigators, regulatory agencies, and other CROs.
• Monitors the status of Federal and State regulations focused on clinical trials and works with the Director of Quality Assurance and Compliance to ensure adherence.
• Ensure all research activities adhere to strict regulatory guidelines (e.g., FDA, GMP) and ethical standards.
• Works closely with the executive management committee in strategic planning, program development and problem identification/solving activities.
• Contributes to the production of written materials related to clinical trial protocols, clinical development program plans, clinical study reports, SOPs, work instructions, and business proposals.  
• Initiates and enhances relationships with customers, participating in professional conferences, networking events, discovery calls, pre-award meetings, project team meetings, and bid defense meetings
• Leads special project assignments, including but not limited to the Company’s placebo response program, rater training, and accelerator site program.
• Oversee and manage the Company’s relationships with scientific advisors, key opinion leaders, and subject matter experts
• Provide educational support for the Company’s employees and sponsors, hosting in-service training sessions, courses, and webinars. Lead and mentor scientific teams, evaluate staff qualifications, and contribute to the career development of researchers.
• Serves as an investigator or sub-investigator on clinical trial projects.
• Other duties as required or assigned.

TRAVELING

Between Corporate New Jersey and New York locations, as needed.

Salary Range: $175,000.00- $220,000.00 annually.  Final compensation is based on skills, experience, location and overall expertise. 
 

• The CSO must possess strong leadership, executive managerial and analytic skills, in parallel with excellent oral and written communication skills.
• CSO must have an MD or PhD degree, significant experience in CNS clinical research (at least 10 years, including significant experience as principal investigator) and (if MD) must be board eligible or board certified by a member board of the American Board of Medical Specialties.
• The CSO must have experience developing clinical trial protocols, clinical study reports, and other documents related to the conduct of CNS clinical trials.
• The CSO must possess knowledge of and experience in regulatory processes, including investigative and consultative, where the latter should include perspectives of both regulators and sponsors.
• The CSO must be a leader in the CNS clinical trial community, exemplified by roles in sponsor companies or CROs, and should have representative activity on professional, industry, academic, or government advisory committees, and professional organizations and/or peer-review journal editorial boards. CME/grand rounds presentations and an active publication record would also support this requirement.
• The CSO must have skills and experience for interacting both with the media and the financial industry.
• The CSO must have a track record of scientific, medical, investigative and leadership abilities and a career orientation that serves the missions of Clinilabs.