Senior Medical Director, Clinical Research Development
• **Must be a U.S. trained MD /Board Certified MD
• ***Must have clinical patient management experience beyond residency.

Northern NJ, onsite /hybrid 3 days.

Summary:

We are currently working with an expanding biotech that is looking to add a physician who has a strong drug development / clinical background for their Clinical Development team. This is a key role in advancing their oncology pipeline by providing expertise for a clinical development studies. They need someone who can add their expertise in clinical development to advance new therapies to patients and is committed to advancing the field of medical research and improving patient outcomes.

Description:

Design and conduct early or late-stage clinical development trials as needed, including, but not limited to assessing clinical safety and efficacy data, performing medical monitoring, and be responsible for other study-related clinical activities.

Interpret reports and prepare oral and written results of product research along with quality and accuracy of work as well as timeliness of deliverables.

Collaborate closely with relevant functions within the company including discovery, translational and biomarker research scientists, toxicologists, clinical pharmacologists, drug safety specialists, and regulatory personnel.

Work closely with other departments, Clinical Science, Data Management, Clinical Operations, Biostatistics) to ensure an integrated approach to flawless execution and systematic oversight of study protocols in clinical development.

Work closely with functional partners to address protocol questions from Health Authorities and Ethics Committees in a consistent fashion.

Required:

MD degree with experience in Oncology.

Minimum of 5 years of clinical experience, including at least 2 years in drug development biotech/pharmaceutical industry.

Must have experience in clinical practice with direct patient care.

Track record in leading clinical trials, including medical monitoring of early and late stage clinical trials.

Must have strong knowledge of clinical research methodologies, GCP, and regulatory requirements.

Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.

Strong passion for clinical trials and improving patient outcomes.

Experience with IND and/or NDA/BLA filings.