About C4 Therapeutics®

C4 Therapeutics (C4T) (Nasdaq: CCCC) is a clinical-stage biopharmaceutical company dedicated to delivering on the promise of targeted protein degradation science to create a new generation of medicines that transforms patients’ lives. C4T is leveraging its TORPEDO® platform to efficiently design and optimize small-molecule medicines that harness the body’s natural protein recycling system to rapidly degrade disease-causing proteins, offering the potential to overcome drug resistance, drug undruggable targets and improve patient outcomes. C4T is advancing multiple targeted oncology programs to the clinic and expanding its research platform to deliver the next wave of medicines for difficult-to-treat diseases. For more information, please visitwww.c4therapeutics.com.

Our Opportunity:

C4 Therapeutics is seeking a highly motivated experienced Clinical Operations professional with hands-on expertise to lead the successful planning and execution of assigned clinical trial(s) in oncology from First in Human through Phase III. Reporting to the Associate Director, Clinical Operations, the Sr Clinical Trial Manager will be responsible and accountable for the development of clinical trial operational strategy and leading planning execution of day-to-day study operations, leading the cross-functional Study Management Team (SMT), managing outsourced CRO and third party vendor activities, and being accountable for adherence with overall clinical trial timelines, budget, quality, and regulatory standards (ICH/GCP, internal SOPs). A genuine interest and understanding of the science supporting the C4 therapeutics pipeline, an ability to work in a multidisciplinary team setting, and a commitment to developing new treatments for patients with cancer are critical for success.

The Role:

• Accountable for delivery of assigned clinical trial(s), budgets, timelines, and resource management with a focus on quality, including making recommendations and decisions regarding operational strategies to support study and/or program objectives.
• Collaborate with the Medical Director and cross-functional teams on the development, planning, and execution of the clinical trial operations strategy for assigned clinical trial(s).
• Lead and manage day-to-day execution of assigned clinical trials to ensure all trial deliverables are met according to established timelines, goals, budget, and quality standards.
• Manage the cross-functional study management team and CRO/vendor(s) related to all aspects of clinical trial operations and continuously assess operational performance through carefully designed performance and quality indicators.
• Effective management of issues and risks, and concise escalation and reporting to senior management, appropriate teams, and collaborating functions.
• Establish study timelines and ensure accurate tracking and reporting of study metrics.
• Develop and execute Study Operational and Vendor Management/Oversight plans.
• Lead identification, RFP/bid defense, and selection of CRO/third party vendors
• Accountable for the development, management, and tracking of clinical trial budget as well as accuracy of trial information; provide ongoing reporting and forecasting to finance.
• Manage and provide documented oversight of CRO and third-party vendors to ensure quality and adherence to ICH/GCP standards as well as established study timelines.
• Contribute to the development of documents including the clinical trial protocol, Investigator’s Brochures, Informed Consent Forms, Case Report forms, responses to questions from IRBs and Ethics Committees. Contribute to clinical sections of IND summary documents, CTAs for initiation of studies ex-US, and responses to questions from regulatory authorities.
• Partner with Data Management and Medical Director to develop Data Review Plan and co-lead execution of routine cross-functional data review for defined study/program milestones (Dose Escalation Meetings, Interim Analysis, Annual Safety reports, IB Updates, Database Lock, CSR, Publications, etc.) including performing clinical data review to ensure the highest standard of data quality.
• Develop strong relationships with Investigators, site staff, and CRO partners.
• Contribute to Clinical Operations/Organizational initiatives to build and optimize business procedures, tools, and guidance.
• Ensure consistent practices with the highest ethical standards in compliance with internal SOPs, ICH/GCP, and local regulations.
• Represent clinical operations to internal and external stakeholders including key opinion/thought leaders.

Your Background:

• BA/BS degree (advanced degree preferred) in health/life sciences or related field.
• Minimum of 5-10 years of drug development experience, particularly in clinical trial management with at least 3 years of independent oncology clinical operations in all phases of clinical trial execution (Start-up, maintenance, closeout) at a pharmaceutical company, biotech company, and/or CRO.
• Robust experience in oncology required.
• Demonstrates extensive knowledge of clinical operations methodologies, organizational, project management, and leadership capabilities as well as strategic insight, decisiveness, and strong judgment.
• Ensures a consistent, standardized approach to operational activities and clinical project management. Champions continuous quality improvement by evaluating methods and approaches and recommending efficient and/or novel approaches.
• Demonstrated experience with developing clinical operations strategy and plans including site monitoring, risk mitigation plans, recruitment plans, and CRO/vendor oversight plans.
• Experience with managing and demonstrating oversight of CROs, vendors, and consultants.
• Extensive knowledge and application of current FDA Regulations, ICH/GCP guidelines in clinical trials.
• Strong computer skills including knowledge of Excel, Word, PowerPoint, Outlook, and MS Project and/or Smartsheet (preferred).
• Outstanding ability to communicate in an open and clear manner, listening effectively and inviting response and discussion with internal partners and external service providers.
• Ability to collaborate effectively with the study team, cross-functional team members and external partners (including investigator and site staff) using collaborative negotiation skills.
• Proficient in risk management to prevent and overcome complex safety and compliance related issues during clinical program implementation.
• Effectively transitions between strategy and operational execution, with the adaptability to modify plans as required based on changes in priority.
• Comfortable in a fast-paced, results-driven, highly accountable environment with large potential impact.
• Some travel post-COVID pandemic required when restrictions are lifted (specifically to Site Initiation Visits, applicable congresses)

C4 Therapeutics is an Equal Opportunity Employer.

C4 Therapeutics is committed to creating a safe and healthy workplace. In order to ensure the safety and health of our employees, C4 Therapeutics requires all new employees to be fully vaccinated against COVID-19 upon the start of their employment, unless they obtain prior approval for an accommodation for medical reasons or due to a sincerely held religious belief or are exempt from this requirement under applicable state or local law. Qualified candidates who are offered the opportunity to join C4 Therapeutics will be required to provide proof of vaccination during the onboarding process.

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