Director, Clinical Development

Details: Novavax, Inc. (Nasdaq: NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines to address a range of infectious diseases worldwide. Using innovative virus-like particle (VLP) and recombinant nanoparticle technology, as well as new and efficient manufacturing approaches, the company produces potent vaccine candidates to combat diseases, with the goal of allowing countries to better prepare for and more effectively respond to rapidly spreading infections. Novavax is committed to using its technology platforms to create geographic-specific vaccine solutions and is therefore involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India and LG Life Sciences of Korea. Together, these companies have worldwide commercialization capacity and the global reach to create real and lasting change in the biopharmaceutical field. We are seeking a Director of Clinical Development. The incumbent will be primarily responsible for developing, in concert with medical writing, clinical trial protocols to implement the company's development programs. He/she will engage outside experts as needed to advise the company re: the subject pathogen, clinical endpoints, etc. He/she will work with the biostatistical group to ensure that clinical trial designs robustly fulfill their goals, and collaborate with clinical operations personnel to project clinical supply needs, ensure adequate materials are available, and identify any issues concerning feasibility. He/she will be responsible, supported by biostatistics, product safety, and medical writing, for creation and routine updating of the Investigators' Brochure. The incumbent will provide expert medical input as requested to support the clinical operations team, assist in resolving issues in data cleaning, provide support as requested in the review of safety reports received by the product safety and pharmacovigilance group, review the output of statistical analyses for safety, immunogenicity and efficacy as required, recommend ancillary ad hoc analyses as may be helpful to better understand the data, and collaborate with medical writing resources to generate clinical study reports leading to product licensure. It is anticipated that this individual will, over time and based on experience and demonstrated accomplishment, assume primary responsibility for conceptualization, in collaboration with other stakeholders, of clinical development plans for one or more vaccine or other biological product development programs from phase I through licensure and be primarily responsible for the clinical progress of assigned programs. The position will be located at our Gaithersburg, MD facility and report to the Chief Medical Officer/Vice President, Clinical Development Responsibilities include but are not limited to: • Providing critical input on the clinical development strategy • Providing medical and scientific guidance for human clinical trials, phases I-IV, for company products under development and developing clinical protocols to ensure all clinical development milestones are met • Participating in medical review of adverse event reports and monitoring of incoming safety data in conjunction with product safety/pharmacovigilance, including evaluating and escalating safety signals • Coordinating and develop information for reports submitted to FDA, CDC, WHO, or other government or regulatory agencies and communications to agencies as appropriate • Participating in monitoring/supporting adherence to protocols as requested by clinical operations personnel • Planning, reviewing and editing Clinical Study Reports • Providing input on the design of preclinical studies supporting clinical strategy • Managing key external technology partnerships • Representing the company and presenting progress on development programs at conferences and meetings, and maintain working relationships with key opinion leaders in the relevant areas • Other duties as assigned Minimum Requirements: • MD (preferred) or PhD with relevance to immunoprohylactic product development and experience in clinical development • Minimum of 4 years' experience in pharmaceutical, biologics, or biotech R&D environment, or other relevant experience in an academic or public sector research environment involving the collection and analysis of human data in the area of infectious diseases • Functional knowledge of concepts in vaccine immunology and vaccine development, preferably with experience in design and conduct of clinical trials • Working knowledge of clinical development pathways for vaccines in the US • Self-starter who will move forward with key initiatives without being prompted • Evidence of effective leadership skills • Strong verbal and written communication skills • Ability to work cross-functionally Novavax, Inc. offers a base salary, annual bonus, stock options, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan. We are an equal opportunity employer that values diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply.
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