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Clinical Scientist Director

2 months ago

Reston, Virginia, United States Skills Alliance Full time

Transformative Cancer Therapies

Skills Alliance is seeking a highly experienced Clinical Scientist Director to join our team dedicated to developing first-in-class and best-in-class targeted cancer therapies. Our portfolio pursues each target with a modality appropriate to its biology, including small molecules, ADCs, and RLTs.

Position Overview

We are looking for a seasoned professional to play a critical role in the design, execution, and interpretation of multiple clinical trials for our oncology drug candidates. The successful candidate will work closely with cross-functional teams to ensure the successful progression of multiple clinical programs.

Key Responsibilities

  • Design and develop multiple clinical trial protocols, informed consent forms, and other study-related documents.
  • Collaborate with principal investigators, key opinion leaders, and clinical trial sites to ensure robust study design and execution.
  • Conduct activities related to data generation and validation, including CRF design and clinical data review/query resolution.
  • Ensure clinical trial data integrity and adherence to regulatory requirements.
  • Contribute to the preparation of clinical study reports, regulatory submissions, and publications.
  • Review development of site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g., DMC) activities.
  • Perform site-facing activities such as training and responding to clinical questions.
  • Participate in the development of clinical development plans and timelines.
  • Present clinical trial data and findings to internal and external stakeholders, including scientific advisory boards and regulatory agencies.
  • May provide mentorship to other team members.
  • Travel may be required.

Requirements

  • PhD, MD, PharmD, MS, or equivalent degree in life sciences.
  • Minimum of 5 years of experience in clinical science, clinical research, or equivalent; preferably in oncology.

Desirable Skills

  • Extensive experience in drug development process, study design, clinical operations.
  • Extensive experience in clinical trial data analysis software and tools.
  • Strong knowledge and skills to support program specific data review, trend identification, and data interpretation.
  • Strong understanding of regulatory requirements and guidelines for clinical trials (e.g., GCP, ICH, FDA).
  • Excellent analytical, organizational, and communication skills.
  • Ability to work effectively in a fast-paced, collaborative environment.
  • Strong problem-solving skills and attention to detail.