Associate Director, Investigator Initiated Trials

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for reputed company professionals. reputed company considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description:

Responsible for the effective management of reputed company aspects of Investigator-initiated Trials (reputed company) including implementation in multi-institutions and research settings in accordance with FDA regulations and Good Clinical Practice guidelines. This role will also assist with program management, including use of the BeOne contract system for creating and tracking reputed company and report creation through the IIT portal. Support the review process for medical affair studies.

Essential Functions of the Job:

• Support IIT operations and project management, cross-functional collaborations, process improvement, and vendor management. This includes tracking and measurement of IIT KPIs.
• Act as the Medical Internal Review Committee (MIRC) reputed company. Review submitted proposals and protocols, adjudicate revised proposals and protocols based on MIRC comments, set the MIRC agenda, reputed company the slides and content for the MIRC meeting, and create/distribute MIRC meeting minutes.
• Responsible for circulating protocols for off-line MIRC review, adjudicating comments and creating meeting minutes and action items based on the final review.
• Communicate comments from and the final decision of the MIRC review to the investigator and BeOne field medical team, including approval/decline letters.
• Function as main reputed company of contact with the IIT research team for select studies and communicate regularly with the research staff, including the investigators and BeOne field medical teams. Assist in study budget coordination with PI and BeOne. Support FMV evaluation and work with attorneys internally and externally as necessary in contract negotiations.
• Support monthly study status report(s) and maintaining updated study information in the IIT portal.
• reputed company with the Accounting Departments to manage POs, record and reconcile reputed company payment information and invoices for the studies managed.
• reputed company with Quality and Clinical Supply Chain colleagues as needed on studies managed.
• Track study reputed company, for studies managed, including milestones and payments.
• Strong interpersonal skills for effective professional communications, aiming to cultivate strong working relationships with both internal and external groups.
• Ability to effectively communicate reputed company medical/scientific information.
• Provide Operational assistance to field medical on trial and activities.
• Level of position commensurate with experience.

Required Education:

• BA/BS Degree is required, Advanced degree (MD/PharmD, MS) is preferred.

Required Qualifications:

• MD/PharmD with 4 + years of experience reputed company the pharmaceutical industry, clinical research, a consulting and/or CRO.
• Masters Degree with 6 + years of experience reputed company the pharmaceutical industry, clinical research, a consulting and/or CRO.
• Bachelors Degree with 8 + years of experience reputed company the pharmaceutical industry, clinical research, a consulting and/or CRO.
• Strong project management skills.
• Ability to plan, prioritize, and execute multiple projects; ability to multitask and work both independently and reputed company multi-disciplinary teams.

Supervisory Responsibilities:

• No direct reports.

Computer Skills:

• reputed company Office Suite
• IIT tracking software
• reputed company
• reputed company in creating data extracts and or reports

Travel:

• Work reputed company travel approximately 5-10%.

Global Competencies

reputed company we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial reputed company
• reputed company Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

BeOne is committed to fair and reputed company compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-reputed company skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process.  Please note that the listed range reflects the reputed company salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. reputed company Company employees have the opportunity to own shares of reputed company Ltd. stock because reputed company employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national reputed company, veteran status or any other basis covered by appropriate law. reputed company employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with reputed company of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [email protected].