Head of Clinical Operations

Lexington, MA
Clinical Development
Full-time
Curis is seeking a dynamic leader to head our clinical operations group. The successful candidate will demonstrate a high level of knowledge of operational methodologies as well as organizational and leadership capabilities, in the field of cancer drug development. The individual must be well-versed in the principles of clinical cancer research, including ICH guidelines and Title 21 CFR applicable sections. This person will be expected to develop and maintain a world-class clinical operations team through leadership and collaboration, as well as delegation of clinical trial execution to Clinical Trial Managers.

Responsibilities

    • Leads the clinical operations team with responsibility for line management, strategic planning and alignment with broader organizational goals.  The team is currently made up of individuals involved in diverse disciplines including, clinical trial managers and associates, data management and programing, and contracts management.
    • Sets overall direction, strategy and performance standards for clinical operations staff to assure that project objectives are achieved.
    • Assists with development and implementation of training plans, annual performance and goals assessments and metrics by which to measure clinical staff performance.
    • Directly participates in and has accountability for overall clinical operations strategy and performance against key trial metrics.
    • Creates a resourcing strategy to support needs for all clinical programs and activities.
    • Maintains a quality-focused clinical infrastructure by developing and implementing SOPs consistent with the resourcing strategy; ensures operational processes, systems and standards are consistent with GxP and are adopted, implemented and documented consistently across trials.
    • Identifies areas of the clinical infrastructure which are in need of improvement and with consultation with senior management; implements corrective action.
    • Identifies and selects high-quality clinical vendors in conjunction with appropriate team members by interviewing and assessing a vendor’s skill set.
    • Establishes robust vendor oversight program and establishes regular metrics and budget review.
    • Ensures inspection readiness of both active and completed studies and programs.
    • Involves in relationships with potential U.S. and ex-U.S. KOLs and trial sites in order to engage and maximize scientific expertise, patient recruitment and data contribution.
    • Prepares and presents trial parameters and clinical information to senior management, vendors, and other key stakeholders.
    • Champions a mindset and approach that fosters collaboration and consistency across Curis.
    • Ensures alignment with broader Curis strategic initiatives and business needs.
    • Ensures advocacy / voice of the patient represented in the planning, design and conduct of clinical trials.
    • Other duties as assigned.

Requirements

    • Bachelor’s Degree in related field with at least 10 years of experience in industry and/or a contract research organization and 8-10 years of experience within a clinical operations function.  Extensive operations experience in oncology clinical trials is a must.
    • Global clinical trials/program management experience in oncology. 
    • Track record of excellence in effective management of multiple projects/priorities and budgets, ranging from early to late stage development programs.
    • Understanding of comprehensive global pharmaceutical regulatory requirements and strategic implications for clinical development operations.
    • Extensive experience with vendor oversight and managing external partnerships and relations. 
    • Demonstration of strong leadership and management abilities.
    • Extensive experience managing clinical operations staff.
    • Proven ability to lead multifunctional teams and mentor junior staff.
    • Ability to remain calm and navigate in a fast-paced and ever-changing small company environment.
    • Commitment to the highest standards of patient management and clinical research.
    • Excellent verbal, written, interpersonal and presentation skills.
For more information, please visit our website at: www.curis.com.

No phone calls please.
**NO RECRUITERS PLEASE**

Please send CV with job code (DCO500) to:
Human Resources, Curis, Inc.


Curis is an Equal Opportunity Employer committed to a diverse, inclusive workplace. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law.