Careers

We take pride in being a company who hires exceptional people - like you - who exemplify high standards and a passion to create significant value and benefits for healthcare professionals and their patients, our employees and our shareholders.

Available Team Positions:

 

Associate Director, Drug Safety & Pharmacovigilance

Reports to:  Executive Director, Drug Safety


Position Summary

As a member of Drug Safety, the Associate Director, Drug Safety will be primarily responsible for the medical review of individual case safety reports. The medical director will supervise the Contract Research Organization (CRO) activities and help to coordinate the data review from the Independent Data Safety Monitoring Committee (IDSMC). The Associate Director will also contribute to safety surveillance activities, safety process, and convention development, and will attend various safety related meetings. He/she will assist in establishing and maintaining the most effective organization of the drug safety department and with ensuring compliance with Drug Safety and Pharmacovigilance regulations. This position reports to the Executive Director, Drug Safety.

Major areas of responsibility

  • Supervise CRO for medical review of individual case safety reports (ICSR) and Adverse Event of Special Interest (AESI) for clinical programs and marketed drugs, including coding, seriousness, expectedness, and company causality assessments.
    • Assist  CRO in the follow-up of important ICSRs to ensure relevant information is sought.
    • Supervise CRO for appropriate medical interpretation and consistency to adverse event case assessment.
  • Provides medical and drug safety support for internal and external customers.
  • Hold monthly safety review team meetings with the CRO to review ICSR case listing and data cleaning.
  • Provides ICSR-based input into signal management activities, as appropriate.
  • Coordinating with Clinical the abnormal echo reviews, sending data packet to IDSMC
    • Get International Pediatric Cardiac Advisory Board (IPCAB) reviews as needed
    • Get benefit risk assessment from the investigator
  • Performs aggregate safety data review to support analysis of similar events.
  • Compile the data for the quarterly Zogenix Safety Review Board Meetings.
  • Participate in the development of safety surveillance and risk management plans for drug development programs.
  • Collaborate with Clinical, Medical Affairs, regulatory colleagues and applicable functional specialists to identify, evaluate and manage safety signals.
  • Provides medical input into departmental initiatives as part of process improvements and ensuring regulatory compliance.
  • Maintains knowledge of global regulatory authority regulations (especially FDA and EMA) and apply appropriately to all activities.
  • Help prepare and review safety section(s) of investigator brochures, protocols, informed consent forms, statistical analysis plans, clinical study reports, NDA/BLA/CTD submissions
  • Review safety TLFs as needed/requested by Clinical

MINIMUM JOB QUALIFICATIONS 

  • Medical Education  (MD, RN, PharmD)
  • Requires a minimum of 5 years of related experience in Safety & PV
  • Experience in Biotech/Pharmaceutical industry mandatory. 
  • Previous experience in neurology/epilepsy a plus.

SKILLS & ABILITIES REQUIRED

  • Knowledge and understanding of international regulatory guidelines and drug safety practices
  • Strong knowledge of individual adverse event case report processing, triage, and medical review
  • Knowledge of medical aspects of drug safety in pre- and post-marketing safety practice
  • Experience with safety databases (Argus preferred) and safety coding dictionaries (MedDRA, WHO Drug)
  • Excellent oral and written communication skills
  • Excellent teamwork and interpersonal skills are required
  • Working knowledge of relevant FDA, EMA, and ICH guidelines, initiatives and regulations governing drug safety ICSR medical review and processing.
  • Proficiency with the Oracle Argus Safety System.
  • Working knowledge of MedDRA and WHO DRUG dictionaries with relevance to ICSR case coding.

SPECIAL WORKING CONDITIONS

Based in Emeryville, CA office

10 - 15% overnight travel required

This job description is intended to describe the essential job functions of this position and is not intended to be an all-inclusive statement of job responsibilities.

We are an equal opportunity employer (EOE). We respect individual differences, embrace diversity throughout the organization, and value the unique strength of each employee.

Please email resumes to careers@zogenix.com with the following subject line: Associate Director, Drug Safety & Pharmacovigilance

 

Director, Project Management

Reports to:  Chief Development Officer


Position Summary

Zogenix is currently seeking a senior Project Management Professional experienced in Pharmaceutical Drug Product Development, to drive project management at Zogenix.  Currently, the Project Manager will oversee the timeline and deliverables for the clinical trials for the company’s primary development product ZX008. In addition, he/she will manage other project teams as assigned and will manage key alliances across all projects as needed.  The successful candidate will apply strong fundamental project management expertise coupled with comprehensive knowledge of the drug development process and launch planning.  In order to enable Zogenix to meet critical business objectives, the Project Manager  will be responsible for the full integration of financial, development and commercialization activities.

Major areas of responsibility

  • Serves as Senior Program Manager for ZX008, a global orphan 505b(2) program for treatment of seizures in Dravet Syndrome
  • Responsible for hands-on program management of the program across internal stakeholders and external vendors, covering CMC, Clinical Development, Regulatory and Medical Affairs activities
  • Provide project templates to support ongoing public company requirements including financial auditing and project related information for quarterly earnings calls;
  • Successful collaboration and interactions with all levels of company personnel to manage quality program delivery on time and on budget; tracks overall program budget
  • Provide ongoing evaluation of the work flow processes, with strong planning and adaptations as necessary to support on time project execution
  • Facilitate establishment of appropriate project goals that enable Corporate and Functional Department goal-setting, and provide progress against goals
  • Establish a Zogenix Alliance Management system and provide Alliance support
  • Formalize and refine New Product Opportunity strategic decision-making process  

MINIMUM JOB QUALIFICATIONS 

  • Bachelor’s degree in a relevant scientific discipline and 7+ years of relevant Program Management / Project Leadership in the pharmaceutical industry or equivalent
  • Strong organizational, facilitation and presentation skills
  • Experience in tracking >5MM budget to plan
  • PMPP certification
  • Advanced Microsoft Project, PowerPoint, Excel capabilities

SKILLS & ABILITIES REQUIRED

  • Demonstrated ability to provide strong direct project management/leadership skills and a proven track record of leading late stage development programs leading to global regulatory approval;
  • Strong understanding of all phases of pharmaceutical product development, and US and EU pharmaceutical regulations
  • Hands-on individual who appreciates the opportunities offered by a small, fast-growing pharmaceutical company;
  • Excellent communication and interpersonal skills; capable of negotiating and informing relevant information across all levels of the company
  • Detail oriented, able to problem solve and apply good judgment to address unexpected challenges

PREFERRED JOB QUALIFICATIONS 

  • Neuroscience experience a plus

SPECIAL WORKING CONDITIONS

Based in Emeryville, CA office

Must be willing to travel as required

This job description is intended to describe the essential job functions of this position and is not intended to be an all-inclusive statement of job responsibilities.

We are an equal opportunity employer (EOE). We respect individual differences, embrace diversity throughout the organization, and value the unique strength of each employee.

Please email resumes to careers@zogenix.com with the following subject line: Director, Project Management

 

Executive Assistant

Reports to:  Chief Development Officer


Position Summary

Zogenix is seeking a professional who enjoys being a part of a dynamic team and does what it takes to get the job done for the success of the company and its leaders. If you are a dynamic person who demonstrates a hands on, can do attitude, and is willing to wear multiple hats then we have an amazing position for you!


The Executive Assistant essential duties and responsibilities include but are not limited to the following:

Major areas of responsibility


  • Handle information of a highly confidential and critical nature.
  • Work collaboratively with all members of the organization and provide assistance as needed.
  • Create and update complex PowerPoint presentations, as well as other documents and correspondence in Word and Excel.
  • Manage calendars and assist in prioritization, time management and maintaining deadlines.
  • Coordinate a variety of internal and external meetings, conference calls, and web meetings across multiple time zones.
  • Coordinate complex domestic and international travel plans, including monthly expense reporting and reimbursement.
  • Screen incoming mail and telephone calls.
  • Provide back up support to other members of the administrative team as needed.
  • Manage office supplies and implement efficiencies
  • Contribute to the culture of the company and general office decorum
  • Support various fun company events!

MINIMUM JOB QUALIFICATIONS 

  • Proficiency with MS Office, including intermediate-advanced skills with Outlook, Word, Excel & PowerPoint.
  • 5+ years administrative experience required, previous experience supporting C level executives.
  • Ability to appropriately handle critical information and sensitive situations in a timely manner.
  • Flexibility to handle a variety of tasks and shift priorities simultaneously.
  • Detail oriented, able to problem solve and apply good judgment to address unexpected challenges
  • Self-motivated, enthusiastic and customer service oriented.
  • Excellent organization and time management skills.
  • Ability to remain calm under pressure and handle a variety of situations with peers and leaders in a professional manner.
  • Ability to work effectively with others in a fast-paced organization
  • Ability to effectively interact with all levels of staff and external contacts; ability to work as an effective team member.
  • Strong level of initiative and ability to work with minimum supervision
  • Must have experience managing projects including the ability to multi-task. A high level of organizational skills and attention to detail is required.
  • Must possess the ability to communicate written and orally in a clear & concise manner.

SPECIAL WORKING CONDITIONS

  • Based in Emeryville, CA office
  • Driver’s license required
  • Employee must occasionally lift and or move up to 25lbs.
  • Preferred experience in pharma or clinical trials support

This job description is intended to describe the essential job functions of this position and is not intended to be an all-inclusive statement of job responsibilities.

We are an equal opportunity employer (EOE). We respect individual differences, embrace diversity throughout the organization, and value the unique strength of each employee.

Please email resumes to careers@zogenix.com with the following subject line: Executive Assistant

 

 

Please email resumes to careers@zogenix.com.

Note to Recruiters: All candidate activity and open positions are managed exclusively through our Human Resources Department, therefore, we kindly request that recruiters not contact employees or hiring managers directly in an attempt to solicit business or present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization.  Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. 


We operate on an agreed set of values at all levels throughout our organization regardless of title, department or location.  These values, woven into our daily activities, decision-making processes and internal and external interactions, focus intensely in these areas:

 

 

Intelligent
We think collaboratively to drive the company's success.
Innovative
We boldly explore options and inspire others to be creative.
Inclusive
We lead with transparency and include the input of others.
Intentional
We passionately pursue our goals while displaying integrity and respect.