Department/Number: Supply Chain Operations/32

Position reports to (job title): Senior Director, Supply Chain Operations

Purpose of Position: The Associate Director of Customer Service in the US will consistently deliver a high standard of operational performance on supply of Zogenix products to customers. This position will be responsible for Customer Service Function and will manage Third Party Logistics Service Provider (3PL).

Primary Responsibilities and Duties:

• Manage all activities at 3PL including order processing, support new customer setup and maintenance, returns, and customer service.
• Support internal and external customers.
• Act as first line of referral for customer issues.
• Resolve customer issues with minimal supervision. Determine when it is appropriate to escalate customer issues to management.
• Coordinate inventory management including incoming and outgoing shipments.
• Provide commercial distribution and logistics support.
• Represent Supply Chain Operations on commercial project teams.

Skills Required:

• Ability to communicate effectively, verbally and in writing, and demonstrate good interpersonal skills interdepartmentally and with external vendors and contractors.
• Strong understanding of the US and EU pharmaceutical regulations.
• Experience with inventory management systems, distribution and commercial supply operations.
• Hands-on individual who appreciates the opportunities offered by a small, fast-growing company.
• Strong project management skills.
• Strong background in customer relations and service.

Minimum Education Typically Required: BS or equivalent

Amount of Experience Typically Required: Minimum of 7 years experience managing commercial drug distribution and related activities.

Position Location: Emeryville

Position Summary:

This position is responsible for developing, coordinating and implementing regulatory strategies (including CMC, pre-clinical and clinical activities) for new product development registrations and licensing. Must have the ability to anticipate and plan for changes in FDA regulations and requirements. Position is responsible for troubleshooting discrepancies between products and FDA requirements, and to strategize filings to meet Company objectives.

Responsibilities include:

• Collaborate with senior management to develop, coordinate and implement the regulatory CMC, non-clinical and clinical strategies for new product development registrations, marketed products and licensing opportunities;
• Work with development teams to develop strategies for regulatory submissions. Generate regulatory submission plans, and direct document development, review, and finalization of responsibilities;
• Oversee the preparation, submission, and approval of Chemistry, Manufacturing, and Controls (CMC), pre-clinical and clinical sections of any and all filings including, but not limited to, IND’s and NDA’s (including 505(b)(2) applications);
• Review planned regulatory submissions and other critical documents to assure they are complete, accurate and consistent with organizational objectives;
• Interface with the FDA and other regulatory bodies regarding CMC, pre-clinical and clinical development issues.

Requirements:

• PhD/PharmD with 5-7 years’ experience in Regulatory Affairs or BS/MS/MSN with 7-12 years experience;
• Experience in working directly with the FDA;
• In-depth knowledge of FDA regulations regarding CMC, pre-clinical and clinical requirements;
• Working knowledge of drug development, IND and NDA process and submissions;
• Ability to develop both short and long term strategic plans, as well as demonstrated abilities to execute such plans successfully;
• Superior scientific writing skills for developing regulatory documents;
• Experience in resolving scientific or safety issues with products;
• Working knowledge of CTD/eCTD;
• Can effectively communicate at all levels of the organization. Must be able to guide the work of others who do not necessarily report to the incumbent;
• Ability to resolve internal personnel issues to maintain a team atmosphere.

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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.