This is an exciting opportunity for a highly motivated individual to lead clinical study operations for novel small molecule cancer therapeutics while playing an instrumental role in the growth of an emerging and well-positioned biotechnology company.

This position is responsible for a broad range of duties, including supervision of clinical research organizations (CROs), central laboratories, and pharmacokinetic analytical laboratory vendors; ensuring adherence to clinical and laboratory budgets; coordinating communication with CROs, clinical sites and Principal Investigators; coordinating activities between clinical sites/CROs, drug supply vendors, laboratory vendors and quality assurance activities; planning and coordination of data monitoring to ensure high-quality clinical trials; and advancing company goals through actively contributing to clinical development strategy.

Responsibilities:

• Lead the internal study team meeting, including setting an agenda to cover key topics and documenting actions and decisions
• Represent Clinical Operations on the program team and contribute to the operational strategy for clinical trial activities on the program
• Lead site and vendor selection processes, including, the selection of Contract Research Organizations (CROs)
• Act as the primary contact with CROs and other vendors for study related matters including, but not limited to, clinical planning, patient recruitment, compliance with protocols, and monitoring of progress from start-up through final study report writing
• Drive execution of clinical trial plans to deliver data supportive of regulatory directives
• Establish critical timelines and direct the activities of employees, CROs, vendors, other collaborators, clinical sites, and clinical investigators to meet required deadlines and target goals
• Devise and implement budget, cost controls, and resource planning to meet corporate objectives
• Work with data management team on eCRFs for appropriate content, clarity, completeness, and performance in accordance with protocols and data requirements
• Work with contracted IVRS/IP management vendor to incorporate randomization strategy into clinical operational activities as applicable
• Ensure timely and accurate data-capture by sites, and promptly address anomalies or delayed entries through communications with CRO, CRAs and sites as applicable
• Contribute to the recruitment, retention and nurturing of key scientific, regulatory, and clinical personnel
• Craft, review, and approve clinical documents and presentations for internal and/or external purposes
• Maintain clinical records in clear and required formats
• Aid in the preparation of clinical sections for all regulatory filings (IND, Annual Reports, AE/SAE reporting, study reports, etc.)
• Exercise independent judgment and discretion
• Support cross-functional development of departmental policies
• Demonstrate leadership and professionalism to build external relationships critical to the success of the organization
• Update job knowledge by participating in educational opportunities; reading professional publications; maintaining professional networks; and participating in professional organizations
• Read, understand, and comply with all workplace health and safety policies; safe work practices; and company policies and procedures
• Follow and apply appropriate laws, regulations, policies, and procedures
• Perform other duties as assigned by supervisor

Supervisory Responsibilities:

This position requires technical and strategic leadership skills; interaction with all levels of employees; and the ability to direct, coach, and evaluate the operational activities of lower-level employees. Directs and controls the activities of a broad functional area through several department managers. Has overall control of planning, staffing, budgeting, managing expense priorities, and recommending and implementing changes to methods.

Required Education and Experience:

• Undergraduate degree in Biological Sciences or professions (pharmacy, medicine, nursing, or other allied health sciences) with a minimum of 10 years of experience.
• At least 5 years of relevant oncology experience in clinical operations in pharmaceutical company or CRO including trial set-up, monitoring, and close-out of US and non-US trials at all phases of pre-NDA clinical research (Phases 1-3) preferred.
• Demonstrated track record of successfully supporting multiple projects, trials, and priorities.
• Experience with managing study vendors (e.g., CRO, IRT/IXRS, central imaging and laboratories) preferred.
• Practical knowledge and implementation of ICH-GCP guidelines and US and ex-US regulations.
• Experience with electronic systems (e.g., eTMF, EDC, and other data management software).
• Ability to work well with global, multi-disciplinary teams.
• Must be able to thrive in an entrepreneurial, fast paced, and dynamic work environment.
• Must be organized with excellent oral and written communication skills.
• Strong learning orientation, curiosity, and passion for science and patients.
• Previous supervisory experience preferred.

Other Information:

NiKang currently anticipates the annual base salary range for this Director- or Senior Director-level role is estimated to be from $210,000 to $255,000. Our job titles span more than one career level. The actual title for this role and final salary amount offered to a successful candidate may be higher or lower than the estimated range and will depend on several factors that include, but are not limited to, the geographic location of the candidate, the type and length of applicable experience, education, and other relevant factors. In addition to base salary, the hired applicant for this position will be eligible to receive an annual discretionary bonus and potential equity awards based on factors such as individual and organizational performance. NiKang offers a comprehensive benefit plan to eligible employees, including eligibility to participate in a company-sponsored 401(k) program, Paid Time Off benefits, eligibility for medical, dental, vision benefits, flexible benefits, short-term disability and life insurance benefits. NiKang reserves the right to amend, modify, or terminate its compensation and benefit programs at its sole discretion.

The statements contained herein are intended to describe the general nature and level of work to be performed. The statements are not to be construed as a complete and/or definitive list of the responsibilities, duties, and skills required of the employee. Furthermore, they do not imply a contract for employment and are subject to change with or without notice at the discretion of the employer.