Senior Medical Director, Clinical Development — Remote

Dren Bio, Inc.; San Carlos (CA); On-site; USD 275,000 - 300,000; Full time

Job summary

Dren Bio, Inc. is seeking a Senior Medical Director, Clinical Development to lead autoimmune clinical studies and shape strategic program plans.

You will partner with Research, Translational Sciences, Clinical Operations, Regulatory, Medical Affairs, and Commercial teams to align medical strategies with corporate goals and patient needs. Ideal candidates hold an MD with Immunodermatology specialization and 4+ years in drug development, including early-phase autoimmune trials.

Qualifications

• MD degree with specialization in Immunodermatology preferred and a minimum of 4 years in industry, or relevant drug development experience in the management and execution of phase I-III trials.
• Experience as medical monitor of early-stage autoimmune clinical trials.
• Willingness to travel up to 25% of the time.
• Permitted to work in the United States

Responsibilities

• Provide key contributions to the development of a clinical development plan and lead the design and implementation of autoimmune clinical studies.
• Serve as the clinical lead and medical monitor for one or more clinical study.
• Contribute to and support the development of protocols, investigator brochures, clinical study reports and review clinical trial documents.
• Provide clinical leadership and medical strategic input for all clinical deliverables: clinical sections of individual protocols, clinical data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications.
• Review and interpret safety data on an ongoing basis to ensure overall safety of the molecule for the assigned section, and supports overall program safety reporting, and other safety related documents in collaboration with pharmacovigilance function
• Conduct investigator meetings and lead site initiation visits with clinical trial investigators
• Translate findings from research and nonclinical studies into clinical development opportunities
• Interact with clinical investigators and thought leaders
• Provide clinical leadership and work in a team environment in interactions with external stakeholders (medical experts, advisory boards, patient advocacy groups) and internal stakeholders (Research, Translational Sciences, Clinical Operations, Safety, Regulatory, Medical Affairs, and Commercial)
• Provide strategic support and work closely with company leadership on strategic and corporate initiatives
• Provide medical support as needed on company and non-company sponsored studies, non-interventional studies and investigator sponsored studies
• Perform other duties as required

Skills

Medical leadership

Clinical development

Autoimmune trials

Regulatory knowledge

Education

MD degree

Immunodermatology

Job description

Dren Bio, Inc. is seeking a Senior Medical Director, Clinical Development to lead autoimmune clinical studies and shape strategic program plans.

You will partner with Research, Translational Sciences, Clinical Operations, Regulatory, Medical Affairs, and Commercial teams to align medical strategies with corporate goals and patient needs. Ideal candidates hold an MD with Immunodermatology specialization and 4+ years in drug development, including early-phase autoimmune trials.