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Executive Director / Vice President Clinical Operations

Role Overview

Chimeric Therapeutics is looking for a Clinical Operations Lead. A senior-level clinical ops leader who drives and leads the successful execution of all operational components of clinical programs using strong leadership, organizational, operational, and management skills. Excellent oral & written communication skills are required with internal & external stake holders to ensure alignment with company goals, study timelines & deliverables.

The Executive Director / Vice President Clinical Operations will report to the CMO.

Key Responsibilities
  • Managing the CROs from the initial selection process to conduct & completion of trials.
  • Participate in the feasibility and evaluation of investigative sites; working closely with the CROs.
  • Oversight of the monitor activities at investigational sites; review monitoring trip reports and monitoring activities.
  • Assist in the review, development and writing of clinical trial documents and manuals, including but not limited to study manuals, laboratory or biomarker plans, and other supporting documents.
  • Create Master ICF template and review/approve site changes (in consultation with study medical director, legal, safety when warranted). Update template for new risks and new amendments information.
  • Assist in the development and management of study timelines and priorities, including recruitment tools/strategy and patient retentions plan.
  • Plan and organized meetings with team support (e.g. investigator/coordinator meetings, DMC, SMC, safety call, etc.).
  • Oversight of drug supply & associated logistics.
  • Participate in data review and discrepancy/query resolution.
  • Participate in coordinating efforts with internal Pharmacovigilance, and safety group.
  • Monitor study-specific timelines and key deliverables; focus on management of all external vendors (e.g. Monitoring, Drug supply vendor, IVRS, Laboratory, etc.).
  • Develop relationships with investigational sites and institutions to enhance conduct of the trial.
  • Acts as preliminary liaison for study sites to convey trial information, and answer questions
  • Builds effective partnerships across functional area leadership.
  • Drives issues to resolution and communicates to ensure that issues have been worked through to completion.
  • Applies change management principles to support communication and implementation of integrated change.
  • Frequently communicates program status to different levels of stakeholders, including Sr. Leadership.
  • Define project timelines and deliverables working closely with cross-functional teams and assuring that they are consistent with the company strategy, and are completed on time, on budget and according to the highest quality and ethical standards. Able to anticipate potential delays and challenges and establish mitigation and correction plans to allow full transparency to the senior leadership.
  • Support the development of budget and effectively manage resources, funding and expenses.
  • Prepare or oversee monthly progress reports and ad-hoc reports, as required.
  • Work closely with external key strategic alliance partners for projects that are being jointly developed.
  • Support process improvement and functional trainings at departmental and company level as needed.
  • Ensure compliance with corporate policies and procedures, and all related healthcare laws and regulations.
Professional Experience/Qualifications
  • BS/BA degree or a relevant degree with strong emphasis on science.
  • Minimum of 8 years of experience in the biopharmaceutical industry or other relevant clinical research experience; with at least 5 years in clinical operations.
  • Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health authority experience.
  • Ability to effectively manage multiple priorities across several studies simultaneously.
  • Prior experience in assisting the conduct and management of multinational clinical trials is preferred.
  • Prior experience in Hematology/oncology required; prior experience in CART is desired
  • Therapeutic Area knowledge.
  • Proficient project management skills.
  • Strong presentation skills.
  • Financial acumen.
  • Demonstrated ability to build effective working relationships, influence, negotiate, and drive cross-functional alignment and organizational engagement. Ability to be flexible, incorporate insights from multiple stakeholders and adapt quickly to changing needs of the organization.
  • Demonstrated ability in functioning with cross functional team and delivering results in a matrix and collaborative environment, and operating across multiple geographies.