Sr / VP Clinical Development

Our client has a proprietary cell therapy platform with a focus in autoimmune and inflammatory therapeutic areas. Be at the forefront of cell therapy innovation by joining scientists, industry veterans and healthcare visionaries and help transform how autoimmune diseases are treated.

We're seeking Senior, Executive or VP Clinical Development candidates with neuromuscular or neurodegenerative expertise for a clinical build for the organization.

Responsibilities:

• Serve as the medical lead for CAR T-cell therapy clinical trials in multiple autoimmune

disease indications, in partnership with internal and external cross-functional teams.

• Support, as the clinical representative, the transition of preclinical projects to clinical

development.

• As the clinical trial study physician, be responsible for clinical deliverables and

activities, including:

• Medical monitoring of clinical trials

• Medical review, analysis, and interpretation of safety, efficacy, and PK and biomarker

data

• Development of clinical trial documents including protocols, ICFs, clinical

development plans, and publications.

• Lead the development of clinical sections of regulatory documents including the IB,

safety updates, clinical study reports, and responses to Health Authorities.

• Actively engage with external investigators and researchers to identify, evaluate, and

support investigator sponsored studies and drive research collaborations.

Requirements:

• MD (or ex-US equivalent) or MD-PhD degree required. Advanced degree or research

experience in immunology preferred.

• 5+ years of clinical research experience with 2+ years of industry experience in clinical

development involved in the design and execution of clinical trials. Experience in early

clinical development and translational medicine preferred.

• Specialty training in rheumatology and/or industry experience in clinical development

of therapeutics in autoimmune diseases.

• Proven ability to interpret, discuss and present efficacy and safety data

• Working knowledge of GCP/ICH, clinical trial design, clinical development processes,

and regulatory requirements.

• Strong ability to communicate and establish effective working relationship with

investigators, collaborators, scientific advisors, CROs, and corporate partners.