Clinical Program Manager (Analgesia)

Job Title: Clinical Program Manager (Analgesia)

Position Location: Emeryville

Primary Responsibilities and Duties:

Zogenix seeks a Clinical Program Manager principally for our Analgesia Program trials for subjects with moderate to severe chronic pain. The job will report currently to the CMO, but the reporting relationship will ultimately transfer to a Senior medical Director when one is appointed. Specific responsibilities include:

• Manage study activities, including investigator recruitment and selection, study start-up, enrollment, data collection, drug projections, and reports;
• Manage study sites and train clinical site staff to ensure protocol and regulatory compliance;
• Ensuring SOP and regulatory compliance of staff;
• Responsible for CRO selection, development of RFPs, budget negotiations, and CRO management;
• Responsible for clinical site budget and contract negotiation;
• Responsible for monitoring plans, coordinating study reports, sections for Investigator’s Brochures, and regulatory documents (e.g., IND, NDA or BLA;
• Interact with investigators and thought leaders for protocol development, presentations and publications;
• Coordinate and participate in investigator meetings;
• Perform Site Qualification Visits;
• Manage program budget and timelines;
• Mentor and develop junior staff (at least one Clinical Research Assistant).

Requirements:

• Bachelor’s degree in a relevant scientific discipline or equivalent. 6+ years of relevant clinical experience in the pharmaceutical industry or equivalent;
• Strong Program Management skills;
• Knowledge of GCP and ICH guidelines required;
• Excellent communication and interpersonal skills;
• Detail oriented;
• Able to problem solve and use good judgment;
• Able to work within a team and to work with general instructions;
• Proficiency with MS Word, Excel, Outlook, Project and PowerPoint;
• Must be willing to travel as required for the project.