Senior Director, Clinical Data Management

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 visit www.c4therapeutics.com

Our Opportunity:

The Senior Director, Clinical Data Management is responsible for leading the C4 Therapeutics, Inc. (C4T) Clinical Data Management (CDM) department. The Senior Director is expected to be a leader in the CDM space, leveraging experience and expertise to drive data management activities. The Senior Director will manage a team of internal and external resources (CRO and consultants). This leader will also support department and cross functional initiatives, process improvements, and development of and/or revisions to SOPs.

The Role:

• Using industry knowledge, experience, and forward-thinking principles to drive C4T Data Management activities.
• Provide leadership, development and mentoring of the CDM team to meet business goals.
• Effectively interact with senior members in Biometrics and Clinical Development for strategic planning to ensure internal standards in accordance with corporate objectives.
• Work collaboratively with internal and external members to coordinate the planning and execution of daily CDM activities.
• Oversee database status with respect to performance metrics, deliverables, and timelines.
• Accountable for overseeing performance of external vendors responsible for CDM deliverables to ensure quality completion of clinical data related deliverables.
• Define, forecast and manage CDM resources (personnel, technology, vendors).
• Lead clinical data strategy (including external laboratory data) across the C4T portfolio of studies, ensuring the CDM team delivers against time, quality and cost targets.
• Partner with the external vendors and internal operations and IT teams to develop CDM system workflows with technology products.
• Work closely with cross-functional teams from Clinical Operations, Medical, Biostatistics, Quality Assurance, Pharmacovigilance, and others as needed.
• Represent CDM capabilities and/or needs to stakeholders.
• Execute clinical trial or program level Clinical Data Management Plans (DMP) and related project level documentation in conjunction with functional area project leads in accordance with internal SOPs.
• Provide CDM operational leadership for the direction, planning, execution, collection and handling of all clinical data to the highest quality standard while ensuring compliance with industry established standards and C4 Therapeutics, Inc. reporting requirements.
• Participate in the development of policies, SOPs, work instructions, CDM standards and clinical development process improvements relating to clinical data management.
• Provide hands-on support for individual programs and studies as needed.
• Perform other duties as assigned.

Your Background:

• Minimum 15+ years of clinical data management and drug development experience in Biotechnology or Pharmaceuticals, oncology experience strongly preferred.
• Bachelor's degree (or higher) in Biology, Pharmacology, Computer Science, Mathematics, Statistics or related field or an equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities to perform these responsibilities.
• Expertise in CRF design, database setup, edit check specification, data review, data cleaning, database lock and archiving activities.
• Demonstrated ability to manage staff, contractor and vendors to deliver project goals for CDM. Experience in developing and implementing CDM standards and procedures.
• Expertise in GCDMP, CDISC data standards, 21 CFR Part 11, GDPR as well as other industry regulations and submissions requirements.
• Experience with various forms of CDM technology, especially Medidata Rave and Veeva CDMS, as well as the procurement and implementation of systems.
• Experience with external laboratory data management.
• Thorough knowledge and understanding of clinical research concepts, practices, and regulations.
• Expertise with inspection and submission readiness.
• Experience in mentoring, motivating and developing data managers.
• CCDM certification a plus

Capabilities:

• Critical thinker with ability to step back and rethink legacy assumptions in the clinical research space
• Excellent cross-functional partnership skills to work across an organization to achieve business objectives
• Collaborate and communicate in an open and clear manner, listening effectively and inviting response and discussion with internal partners and external service providers
• Effectively transitions between strategy and operational execution, with the adaptability to modify plans as required based on changes in priority
• Anticipate and proactively resolve issues when and where possible, applying logical methodology
• Comfortable in a fast paced, results-driven, highly accountable environment with minimal direction, and able to adjust workload based upon changing priorities, with initiative to take on unfamiliar tasks
• Ability to travel domestically and internationally