Vp. Clinical Development Jobs

**Vice President, Clinical Development - Cell Therapy**

Charlton Morris is partnered with a fast-growing 100m+ funded clinical stage biotech, aiming to lead cell therapy with their revolutionary patented technology platform. They strive to overcome the major obstacles in cancer therapy through developing both NK and gamma delta T cell therapies.

Responsibilities

• Build a Advance Phase I-III clinical programs from clinical study design and execution through interpretation of data and publication. Work closely with CROs and partners too.

• Lead a team of translational scientists to develop hypothesis driven translational cell product centric pharmacology, safety, and biomarker strategy to identify key questions for IND(s).

• Design and execute application of clinical biomarkers and companion diagnostic assays.

• Develop and manage the Translational Medicines strategic plan and operating budget..

• Integrate the scientific rationale, regulatory requirements, product development plan, and

commercial goals to build a solid strategic framework for the Clinical Development Plan (CDP).

• In conjunction with clinical operations, establish efficient clinical development timelines,

incorporating key decision points and Go/No Go criteria for the CDP.

• Represent the client externally and build key relationships.

Required skills

● Must have 10+ years of experience in clinical development, including Phase I-III clinical trials.

● Excellent working knowledge of FDA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical drug development.

● Senior level physician researcher with deep understanding and experience in cell therapy

translational medicine, especially in Oncology.

● Fluent in English.

● MD, PharmD (US) or PhD degree with oncology academia/scientific background.

● 3+ years of industry experience in cell therapy.

Interested in learning more?

Apply here or reach out to [email protected] to learn more.

Key words:

Clinical Trials, Oncology Clinical Biomarkers, Immuno-oncology, FDA, , clinical trial design, cell and gene therapy, Phase I-III clinical, IND.