Sr Clinical Scientist

POSITION SUMMARY:

We are seeking a highly motivated and skilled Senior Clinical Scientist/Clinical Development Manager to support our innovative molecular therapeutics efforts. This role combines scientific expertise in clinical trials with robust program management skills to drive the development and execution of our clinical studies.

KEY RESPONSIBILITIES:

• Clinical Trial Design and Oversight:

  • Design clinical trial protocols.
  • Oversee the implementation of clinical trials, ensuring they adhere to scientific standards, regulatory requirements, and ethical guidelines.
  • Collaborate with biostatisticians to ensure appropriate data analysis methodologies are employed.
  • Monitor trial progress, analyze interim results, and prepare reports for regulatory submissions.
  • Contribute to core clinical documents: clinical development plan, target patient profile, site training materials.

• Program Management:

  • Develop and maintain a comprehensive program plan that encompasses all aspects of the clinical trial lifecycle from inception through completion.
  • Coordinate cross-functional teams across clinical operations, regulatory affairs, and other departments to ensure alignment and effective execution of the program.
  • Manage timelines, resources, and budgets to ensure project milestones are met on schedule and within budget.
  • Identify risks and implement risk management strategies to mitigate potential impacts on the program.
  • Develop content and reports for advisory boards, steering committees, internal and external training decks

• Stakeholder Engagement:

  • Serve as the primary point of contact for all program-related communications, including updates to senior management and external partners.
  • Build and maintain relationships with clinical site teams, external CROs, and other stakeholders.
  • Ensure transparent communication across all levels of the project team and stakeholders.

• Regulatory Compliance:

  • Ensure all clinical trial activities comply with regulatory standards and ethical practices.
  • Prepare documentation and support regulatory submissions and interactions.
  • Stay updated with changes in regulatory requirements and industry standards.

QUALIFICATIONS:

• Advanced degree in a life sciences or related field (Ph.D. preferred).
• Proven experience in clinical trial design and management, particularly in oncology or personalized medicine.
• Strong understanding of regulatory requirements and clinical development stages.
• Excellent project management skills with a proven track record of leading cross-functional teams.
• Ability to communicate effectively with a variety of stakeholders including scientific and non-scientific audiences.
• Detail-oriented with strong analytical and problem-solving skills.