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 companys 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
Apply Now
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 companys 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
Apply Now