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:

 

 

Senior Director, Clinical Development

Reports to: Executive Director, Clinical Development

Position Summary

The Senior Director, Clinical Development will play a key role in strategy development, leadership, design and execution of ongoing and new development programs. He/she will successfully lead one or more clinical development teams (US and/or EU-based) to deliver high quality data for registration. The position requires the ability to partner with Regulatory, Early Development, Medical Affairs, Commercial and other stakeholders to deliver clinical programs for registration and launch. The successful candidate will have direct and recent experience with US and EU regulatory interactions for late phase development, and in CRO management, KOL interactions, and product launches.  

Major Areas of Responsibility

  • Provide therapy area medical and scientific expertise to Clinical Development and other stakeholders to maintain Zogenix’s position in the orphan epilepsy space and to understand emerging medical discoveries and trends.
  • Lead the execution of a global clinical development program in the US and EU, providing on-site leadership and guidance for the clinical development team
  • In partnership with Regulatory and Project Management, oversee and ensure the quality, coordination and timeliness of clinical sections of IND's, Investigator Brochures, CTA's, ISS', ISE's and clinical expert reports, including writing and editing 
  • Work with partners to assure that the strategic positioning is in line with company goals and regulatory requirements
  • Anticipate trends in medicine and industry that may/will have an impact on the clinical/commercial viability of products and integrate factors into planning
  • Demonstrate leadership for the clinical development team by effectively communicating the strategic vision, the operational plan needed to achieve the vision
  • Prepare abstracts, manuscripts and presentations for external meetings In conjunction with finance and clinical operations, effectively manage budget and resources, funding and expenses for development projects
  • Possess a solid understanding of the pharmaceutical industry, company competition and commercial side of business
  • Attract and develop talent, coach and mentor others to higher levels of performance
  • Create an atmosphere of innovation and continual improvement 

MINIMUM JOB QUALIFICATIONS

  • Doctoral level degree (MD, PhD, PharmD, PsyD) strongly preferred
  • Experience in CNS development (Psychiatry or neurology)
  • 8+ years clinical development experience including successful product registration in the U.S., Europe 

SKILLS & ABILITIES REQUIRED

  • Proven track record of successful leadership of clinical development project teams
  • Possess extensive knowledge of the late stage clinical development process
  • Experience in small molecule development and registration
  • Experience building strong relationships within the group (Regulatory, Product Development) and across functional groups (Medical Affairs, Commercial) to achieve results
  • Proven track record of success of directly leading, managing & developing talent; Build teams by understanding the skills and capabilities needed to effectively meet goals and objections and align them with the talents and capabilities of team members.
  • Excellent writing and communication skills, experienced in presentations (internal and external) and regulatory writing (IND, CTD sections)
  • Ability to make significant decisions and recommendations and persuasively present data and support materials to gain approval and sponsorship for projects from senior management.
  • Skilled at presenting opinions and recommendations persuasively and authoritatively utilizing compelling information, strong influencing skills, personal credibility and strength of one's convictions and commitment.
  • Ability to handle obstacles and roadblocks by anticipating challenges and preparing well thought out arguments and contingencies.
  • Proven track record of garnering support for projects and recommendations through on-going collaboration, open and influential communications and commitment to improvement/change.

SPECIAL WORKING CONDITIONS

  • Ability to travel as required, including international travel. Average 10-20%, reaching 50% or more in some months.

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: Sr. Director, Clinical Development

 

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

 

Senior Director, Drug Safety

Reports to: Chief Medical Officer

Position Summary
The Senior Director, Drug Safety has overall responsibility for leading Drug Safety and directing the safety surveillance of all company investigational and postmarketing drug products, and for managing patient safety and meeting regulatory reporting requirements.  Directs and conducts analyses of changing risk/benefit profile of company drugs in clinical trials and postmarketing to identify potential safety signals, and implements appropriate safety updates and risk mitigation plans. S/he will be an active member of committees and teams involved in company REMS and Safe Use initiatives and will participate in regulatory meetings when needed.  The Senior Director, Drug Safety will be involved in due diligence of potential in-licensing opportunities.

Major Areas of Responsibility

  • Serves as medical safety expert for all products in all stages of development (Phase 1, 2 and 3 and post-approval).
  • Provides oversight of all safety services including review of medical coding of adverse event data and management of SAEs through the entire lifecycle including preparation of similar-event analyses for unexpected and related serious adverse events (SAEs) from clinical trials and postmarketing activities.
  • Directs the development, preparation and compliance of periodic and annual safety reports (eg. US IND annual progress reports, EU annual safety reports, periodic line listings, NDA safety updates, etc.), investigator communications, product labeling/package inserts and other reports as necessary, including relevant sections of an NDA and MAA.
  • Manages compliance with SOPs and FDA and global regulations for the reporting of adverse events to regulatory authorities.
  • Manages internal staff and external resources to ensure delivery of quality pharmacovigilance services.
  • Leads and manages the Drug Safety Review Board for all products.
  • Lead interface with IDSMC (Independent Data Safety Monitoring Committee).

MINIMUM JOB QUALIFICATIONS 

  • RN, PharmD or MD is required.
  • Requires a minimum of 8 years experience of drug safety experience.  (ideal 10+ years experience with 5+ years in a senior role)
  • An in-depth knowledge and thorough understanding of FDA, EU, and global regulations, ICH guidelines, and GCPs that govern drug safety and pharmacovigilance are required.
  • Experience with safety databases, and expertise in clinical safety assessments, safety signal detection and risk management, including interactions with regulatory authorities are required.

PREFERRED JOB QUALIFICATIONS 

  • In-depth understanding of clinical product development in the pharmaceutical industry.
  • Must be able to demonstrate extensive experience in the design of clinical studies and have a strong working knowledge of safety reviews for input into critical documents for drug development.
  • Drives implementation of department's strategy in alignment with Regulatory Affairs, Clinical Operations, Compliance and company goals.
  • Experience in risk management, epidemiology, statistics, and working knowledge of current FDA REMS requirements.
  • Develops and maintains strong collaborative internal and external working relationships.
  • Ability to research and understand the safety profiles of competitor products within therapeutic areas of interest to help develop effective competitive strategies.

SKILLS & ABILITIES REQUIRED

  • Possesses a thorough knowledge of current FDA regulations and guidances regarding REMS and risk management programs.  
  • Possesses leadership skills and ability to interact with senior management.
  • Must be a demonstrated self-starter and team player with strong interpersonal skills.
  • Excellent written and verbal communication abilities.

SPECIAL WORKING CONDITIONS
Willing to travel up to 10%

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: Senior Director, Drug Safety

 

 

 

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.