Skip to main content

Clinical Director (CAR-T therapy)

Full-time @Northreach in Advanced Therapies , in Research and Development Email Job

Job Detail

  • Job ID 10737
  • 3

Job Description

Northreach is a dynamic recruitment agency that connects businesses with top talent in the Advanced therapy, fintech, and digital sectors. Our mission is to provide a seamless and personalised recruitment experience for clients and candidates, and to create a positive work environment that encourages equality, innovation, and professional growth.

Position Overview:

We are seeking a highly qualified and experienced Director of Research and Development (R&D) specializing in Chimeric Antigen Receptor T-cell (CAR-T) therapy. The Director will lead and oversee all aspects of R&D activities related to CAR-T therapy, from conceptualization to clinical translation and beyond. This individual will play a pivotal role in driving innovation, guiding scientific strategy, and advancing our organization’s efforts in the development of novel CAR-T therapies to address unmet medical needs.

Responsibilities:

  • Strategic Leadership: Provide strategic direction and leadership for the clinical stage development of CAR-T therapies, with a strong emphasis on biomarker strategy, ensuring alignment with organizational goals and objectives.
  • Biomarker Strategy Development: Lead the development and implementation of biomarker strategies to identify predictive, prognostic, and pharmacodynamic biomarkers for patient stratification, treatment response monitoring, and mechanistic understanding of CAR-T therapies.
  • Clinical Program Management: Oversee the planning, execution, and monitoring of multiple clinical trials, from Phase 1 through Phase 3, integrating biomarker endpoints into study designs to optimize patient selection and therapeutic efficacy.
  • Operational and Diagnostic Support: Provide operational and diagnostic support to ensure the seamless implementation of biomarker strategies into clinical trials, including coordinating diagnostic testing and interpretation, managing operational logistics, and troubleshooting any issues that may arise.
  • Cross-functional Collaboration: Collaborate closely with cross-functional teams, including Research and Development, Regulatory Affairs, Clinical Operations, and Medical Affairs, to drive integrated development plans that leverage biomarker insights to inform clinical decision-making.
  • Regulatory Compliance: Ensure compliance with regulatory requirements and guidelines, including FDA and EMA regulations, pertaining to biomarker qualification and utilization in clinical trials.

Qualifications:

  • Advanced degree in a relevant scientific discipline (e.g., MD, PhD, PharmD) required.
  • Minimum of [10-12] years of experience in clinical stage development within the biopharmaceutical industry, with a demonstrated expertise in biomarker strategy development and implementation.
  • Proven track record of successfully leading clinical development programs from Phase 1 through Phase 3, with integrated biomarker endpoints, resulting in regulatory approvals.
  • Deep understanding of CAR-T cell therapy development, including knowledge of preclinical and clinical research methodologies, regulatory requirements, and biomarker technologies.
  • Strong leadership and managerial skills, with experience leading and developing high-performing teams.
  • Excellent communication and interpersonal skills, with the ability to effectively collaborate with internal and external stakeholders.
  • Demonstrated ability to think strategically, make data-driven decisions, and solve complex problems in a fast-paced environment.
  • Prior experience in interacting with regulatory agencies (e.g., FDA, EMA) and preparing regulatory submissions related to biomarkers is highly desirable.
  • Ability to travel domestically and internationally as needed.

Northreach is an equal opportunity employer and we do not discriminate against any employee or applicant for employment based on race, colour, religion, sex, national origin, disability, or age. We are committed to promoting diversity, equity, and inclusion in the workplace and hiring practices, therefore only partner with business that promote DEI. We strive to create a welcoming and inclusive environment for all employees.

Required skills

Other jobs you may like