Entry Level Clinical Development Director

Job Title: Entry Level Clinical Development Director

Location: Washington...

Type: Full-time, On-site (4 days in office)

Experience: 0-5 years

About the Job

Our client is an innovative, Washington based biotech company at the forefront of immuno-oncology, dedicated to developing transformative therapies across various stages of development, from pre-clinical to clinical trials. With a diverse pipeline of assets targeting novel immune pathways in cancer treatment, and a mission to bring next-generation therapies to patients.

The right candidates will lead the development of pre-clinical oncology assets, focusing on advancing drug candidates from pre-clinical stages through early clinical trials. This role suits a medically qualified professional with strong clinical experience, eager to contribute to immuno-oncology therapy development in a biotech setting.

Key Responsibilities:

Drug Development Leadership:
• Lead the clinical development strategy for pre-clinical immuno-oncology assets, focusing on advancing promising candidates from pre-clinical stages through early clinical development.
• Partner with pre-clinical, translational medicine, and regulatory teams to ensure that drug development milestones are met.
• Contribute to defining the clinical development path, including key decisions on drug formulation, dosing strategies, and patient selection criteria.

Pre-Clinical to Clinical Transition:
• Work closely with research teams to understand the scientific basis of pre-clinical programs and help shape their clinical potential.
• Guide the transition from pre-clinical to clinical development, including preparation for IND submissions and early-stage clinical plans.
• Act as the key clinical point of contact for cross-functional teams, helping to ensure that drug candidates are developed with a clear clinical and regulatory pathway.

Regulatory & Data Strategy:
• Support the preparation of regulatory documents and submissions, including INDs and CTAs.
• Assist in the development of biomarker strategies, patient selection, and other clinical aspects critical to the drug development process.
• Provide medical oversight and expertise in the interpretation of early clinical data to help guide the next stages of development.

Cross-Functional Collaboration:
• Work with the broader clinical and scientific teams to align early-stage programs with the company’s overall clinical development strategy.
• Collaborate with external partners, investigators, and regulatory bodies as needed to support drug development efforts.
• Contribute to internal and external scientific communications, presentations, and publications to share the progress of clinical development programs.

Qualifications and Experience:
• MD Required, with specialization in oncology, immunology, or related fields.
• 0-5 years of industry experience in clinical development within biotech or pharma.
• Experience or strong understanding of clinical trial design, including the ability to oversee early-phase studies.
• Knowledge of GCP, ICH guidelines, and the regulatory environment for drug development

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