Sr. Director of Clinical Affairs - GI Specialist

Our F500 Pharma client is seeking a Senior Director, Clinical Affairs to lead clinical research activities to support development, approval, and commercialization. The role will be responsible for developing clinical strategies of multiple clinical trials of varying size and complexity to support regulatory submissions within the US and globally. The position will work in close collaboration with R&D, Regulatory, Clinical Operations, Medical Affairs, Marketing, Quality, Data Management, and Biostatistics.

RESPONSIBILITIES

• Provide strategic management of programs; guide clinical science of programs from study design and protocol development through completion of final study report and regulatory filings.

• Participate in Investigator selection, recruitment, and training; Interacts with Investigators and study sites during study conduct.

• Plan and create written and oral presentations of clinical study information; participate in Investigator’s Meetings; reports clinical study results to senior leadership as needed.

• Collaborate with and influences R&D, Quality, Clinical Operations, Regulatory and other leaders around product improvements, technologies, intellectual properties, and other clinical issues.

• Collaborate with Marketing to develop and identify studies to support commercial operations.

• Foster relationships with top scientific key opinion leaders.

• Provide effective input for promotional review committees.

• Support the R&D organization as a medical monitor and medical expert for clinical studies.

• Ensure that sponsored clinical trials are executed in accordance with Food and Drug Administration (FDA) regulations, Institutional Review Board (IRB) approval, and Good Clinical Practices (GCPs).

• Plan and assist with the preparation of regulatory submissions (e.g., INDs, NDAs, IDEs, PMAs, and PMA supplements).

• Partner with Data Management and Biostatistics to ensure that clinical studies are properly planned, performed, and analyzed.

• Interact with investigational sites, clinical consultants, Contract Research Organizations, and other vendors.

MUST HAVES – QUALIFICATION SUMMARY

• MD required
• Extensive GI experience (Either a Gastroenterologist or Enterologist)
• Direct medical monitoring experience for pharmaceutical/biotechnology organization
• Pharmaceutical industry experience with leadership experience in clinical trials/research
• Proven track record of successfully in designing, planning, and executing clinical studies.
• Strong communication (oral and written) skills including publications, regulatory documents, and presentations.
• Executive Communication/Presentation; communicate and present at the executive level: proficiency in stakeholder buy in, strong cross functional communication, organizational navigation, building rapport across functions and levels of management.

NICE-TO-HAVES

Global pharmaceutical product development experience

LOCATION

Remote if willing to accommodate East Coast Hours

START & TERM

Immediate. 6-month initial contract with strong likely hood to extend for several years