Executive Medical Director - Clinical development - Immunology

Location: San Francisco, USA

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A fast-growing biotech in San Francisco is looking for an Executive Medical Director to manage the clinical development of drug candidates including phase I-IV studies and across multiple therapeutic areas. The successful candidate will have a strong understanding of pharmaceutical drug product development including clinical trial management, IND and NDA submissions, medical monitoring and GCP principles. In addition, this individual will have extensive experience collaborating with Clinical Operations, Research and Clinical Pharmacology, Regulatory Affairs, Publication Planning and other key stakeholders. The Executive Medical Director may work closely with Medical Affairs in review of investigator-initiated and post-approval studies. This role will combine strategic capability with hands on execution.

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Essential Duties and Responsibilities:

• Develop protocols to execute clinical development strategies

• Work cooperatively with Clinical Operations and designated CROs to execute the programs (e.g. lead study start up and database lock medical monitoring activities; address medical monitor inquiries from sites or Operations; perform data and coding reviews; draft/present clinical slides for Investigators Meeting, Advisory Boards and therapeutic/monitor training; review draft CRFs, etc.)

• Participate as a key member in portfolio management and clinical program planning

• Ensure that the Clinical Science department works closely with Research and Clinical Pharmacology, Medical Affairs and Regulatory as appropriate for effective execution of various programs

• Work with academic leaders/advisers to develop clinical strategy

• Write/edit clinical reports, investigator brochures and clinical aspects of Regulatory submissions; support all other Regulatory activities and NDA related questions

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Knowledge and Skill Requirements:

• M.D. degree with a minimum of 5 years’ industry experience, or comparable experience in the management and execution of phase I or II-III trials with credible compounds/established companies

• Board certified or eligible in either immunology, inflammatory diseases, hematology or oncology

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The company is a clinical stage biotech with commercialized products and an ambitious pipeline which will develop drugs to fight difficult auto immune diseases, cancer and metabolism related illnesses. For more information on this role please forward your resume to stuart.gilboy@rbwconsulting.com

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Excellent salary, benefits bonus and stock scheme