VP, Clinical Science, Neurology
Employment Type: Full-Time
Zogenix, Inc. NASDAQ:ZGNX) is a global biopharmaceutical company focused on the development of transformative therapeutics for rare diseases. Based in Emeryville, California, the company has experienced significant key events in its evolution over the past 12 months. In June 2020, the FDA approved Fintepla (fenfluramine) a seizure treatment for a rare and severe form of childhood epilepsy known as Dravet Syndrome, which impacts over 20,000 in the US alone. Also, in September of 2019, Zogenix completed a $250 million acquisition of Modis Therapeutics, a privately held biopharma company focused on developing novel therapies for rare genetic diseases. These milestones, coupled with operations in Europe, a key partnership in Japan, and over $400 million in cash and marketable securities, underscore Zogenix strong and growth-oriented trajectory as they continue their journey to help patients and families suffering with rare diseases.As the company growth continues, they seek to add a seasoned executive into the new role of Vice President Clinical Science/Development. As part of Zogenix, this individual will be a key leader of the Clinical Science team, participating in strategic decisions and providing informed and progressive guidance, strategy planning and execution, with an initial specific focus on neurology.Key Responsibilities:Partnering with Zogenix Development leadership, the Vice President, Global Clinical Sciences will support the organization to grow the value of our products through clinical program design, data analysis and reporting, and registration, while participating in strategic company and brand initiatives. The incumbent will lead clinical science, medical writing and biometrics to collaboratively deliver high quality dossiers for global registration. The position requires the ability to partner with Regulatory Affairs, Early Development, Clinical Operations, and other stakeholders to advance global submissions and new project starts. The successful candidate will be a skilled manager and have direct and recent experience with US and EU regulatory interactions for late phase development, ESL interactions, and product launches.Specific responsibilities include:* Provide therapy area medical and scientific expertise to Development and other stakeholders.* In partnership with Regulatory Affairs and other stakeholders, lead the compilation of Fintepla global regulatory submissions, providing on-site leadership and guidance for the clinical team* Lead the Fintepla Lifecycle Management Initiative, as a member of the Global Product Team* 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* Ensure that the strategic positioning is in line with company goals and anticipate and plan for problems/challenges and establish contingency plans through collaboration with peers* Anticipate trends in medicine and industry that may/will have an impact on the clinical/commercial viability of products and integrate factors into* Assist Business Development in evaluation of new assets and opportunities.* Engage and inspire the clinical science team by consistently communicating the strategic vision, the operational plan to achieve the vision and by modeling the effort it takes to accomplish a successful product.* Work to develop clinical science team members to grow their area expertise and leadership capabilities. Attract and develop talent, coach and mentor others to higher levels of performance. Create an atmosphere of innovation and continual* Work with other team members to prepare abstracts, manuscripts and presentations for external meetings as well as author clinical sections of regulatory documents (IB, IND sections).* Lead the development of a clinical science budget and effectively manage resources, funding and* The ability to think globally, strategically and innovatively about the future of the disease state and company's therapeutic agents and possess a solid understanding of the pharmaceutical industry, company competition and commercial side of business, including Marketing and Sales, Market Access, Pricing/Reimbursement, Business Development, Medical Affairs, Pharmacovigilance and Supply Chain.Qualifications and Abilities:* Doctoral level degree* 7+ years clinical development experience including successful product registration in the US or EU* Experience in Neurology* 5+ years' experience in managerial role* Experience in epilepsy and/or orphan disorders preferred* Experience working with Biometrics staff to design statistical analyses for clinical trials* Proven track record of successful leadership in clinical development* Possess extensive knowledge of the late stage clinical development process* Experience in small molecule development and the registration process, including meetings with regulators and response creation* Excellent writing and communication skills, experienced in presentations (internal and external) and regulatory writing (IND, CTD sections)* 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* Ability to make significant decisions and recommendations and persuasively present data and support materials to gain approval and sponsorship for projects from senior* Skilled at presenting opinions and recommendations persuasively and authoritatively utilizing compelling information, strong influencing skills, personal credibility and strength of one's convictions and* Ability to handle obstacles and roadblocks by anticipating challenges and preparing well thought out arguments and* Proven track record of garnering support for projects and recommendations through on-going collaboration, open and influential communications and commitment to improvement/change.