Head of Clinical Science

Cullinan Oncology

Cullinan Oncology

Administration
United States
Posted on Thursday, June 27, 2024
Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients.
We have strategically built a diversified portfolio of clinical-stage assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in both oncology and autoimmune disease. Our portfolio encompasses a wide range of modalities, each with the potential to be best and/or first in class.
Anchored in a deep understanding of oncology, immunology, and translational medicine, we create differentiated ideas, identify the most appropriate targets, and select the optimal modality to develop transformative therapeutics across a wide variety of cancer and autoimmune indications.
We push conventional boundaries from candidate selection to differentiated therapeutic, applying rigorous go/no go criteria at each stage of development to fast-track only the most promising molecules to the clinic and, ultimately, commercialization.
With deep scientific expertise, our teams exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients.
We are seeking an accomplished, dedicated professional to lead our clinical research scientist (CRS) team and manage/coordinate clinical department operations. The incumbent will be critical in leading and overseeing all aspects of the clinical science implemented in clinical trials. As the Head of Clinical Science, you will collaborate with cross-functional teams to ensure the successful execution of clinical trials, provide scientific leadership, and ensure compliance with regulatory standards and best practices.

Position Responsibilities:

  • Team Management: Lead and supervise the CRS and provide guidance and support to achieve trial objectives. Foster a collaborative and supportive work environment that encourages team excellence and professional growth.
  • Strategic Planning: Develop and implement strategic plans for the clinical department that align with the organization's mission and objectives. Identify opportunities for growth, improvement, and expansion of clinical services.
  • Oversee Medical Document Development: Supervise CRS in creating robust clinical trial documents, including but not limited to the study protocol, investigational brochure, and informed consent form, ensuring scientific validity, ethical considerations, and regulatory compliance.
  • Study Oversight and Program Support: Oversee ongoing clinical studies and CROs, providing guidance, support, and mentorship throughout the lifecycle of clinical trials. Support CRS activities for one or more programs as needed.
  • Regulatory Compliance: Ensure all clinical trials follow relevant laws, regulations, and guidelines, such as Good Clinical Practice (GCP) and International Council for Harmonization (ICH) guidelines.
  • Data Management: Collaborate with the data management team to establish SOPs in data capture systems and ensure the accuracy, integrity, and completeness of clinical trial data.
  • Budget and Resource Management: Collaborate with the clinical operation team to effectively manage clinical research budgets and resources, optimizing efficiency while maintaining high-quality standards.
  • Performance Evaluation: Establish performance metrics and benchmarks for clinical staff. Support department leadership in conducting regular evaluations and providing constructive feedback to enhance individual and team performance.
  • Cross-function Collaboration and Communication: Foster effective communication and collaboration between the clinical science team, safety, biometrics, regulatory affairs, and other relevant functions.
  • Risk Management: Identify potential risks and challenges in clinical trials and develop risk mitigation strategies to ensure successful trial outcomes.
  • Quality Assurance: Implement quality control measures to monitor trial conduct and data integrity and ensure compliance with internal policies and external regulations.
  • Documentation and Reporting: Oversee the preparation of trial-related documents, including clinical study reports, publications, and presentations for internal and external stakeholders.

Candidate Requirements:

  • A doctoral degree or equivalent in a relevant life sciences discipline.
  • Strong leadership and management skills with the ability to effectively motivate and develop teams.
  • Extensive experience conducting clinical trials, with a proven track record of successful clinical trial management and delivering results within timelines and budgets.
  • Thorough understanding of clinical trial regulations, guidelines, and industry best practices (e.g., ICH-GCP, FDA, EMA).
  • Excellent communication, presentation, and interpersonal skills to collaborate with cross-functional teams, investigators, and external partners.
  • Analytical and problem-solving capabilities and the ability to make informed decisions based on scientific evidence and data.
  • Knowledge of various therapeutic areas (e.g., oncology and immunology), and an ability to adapt scientific knowledge to clinical trial scenarios.
  • A strategic mindset and the ability to drive innovation and continuous improvement in clinical trial processes.
  • Demonstrated strategic thinking and problem-solving abilities to drive the success of the clinical department.
Cullinan Therapeutics is proud to be an Equal Opportunity Employer. We are committed to creating an inclusive and diverse environment for all employees and applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.