Director/Sr. Director, Clinical Development
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Novavax, Inc (Nasdaq:NVAX) is a biotechnology company that creates transformational vaccines that address some of the world’s most pressing infectious diseases. We have more than a decade of experience contending with some of the world’s most devastating diseases, including COVID-19, seasonal influenza, RSV, Ebola, MERS, and SARS. Hard-won lessons and significant advances illustrate that our proven technology has tremendous potential to make a substantial contribution to public health worldwide.
Our scientists are committed to developing vaccine candidates for some of the world’s toughest viral threats by utilizing the power of our innovative recombinant nanoparticle vaccine platform. Our vaccine technology combines the power and speed of genetic engineering with the immunogenicity enhancing properties of our Matrix-M™ adjuvant to efficiently produce highly immunogenic particles targeting some of the most pressing viral infectious diseases.
Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic.
Summary of the Position:
We are seeking a physician-scientist to serve as a Director/Senior Director within the Clinical Development. The incumbent will be primarily responsible for developing and executing an integrated clinical trial program including protocol design and medical oversight of ongoing studies. He/she will be responsible for obtaining scientific advisory input, work with biostatisticians for phase 2 and 3 design and analyses, support regulatory interactions for product advancement, and work closely with operations to provide advice and decision making regarding medical input to achieve operational excellence.
The candidate must demonstrate strong collaborative skills to work across various phases of clinical development. Medical insight across a myriad of functions from discovery to manufacturing are expected. Prior experience in a Biotech environment will be highly beneficial, as this role will be working on product development in an extremely fast paced and intense environment.
The position will be located in Gaithersburg, MD with potential for remote work but with an expectation of at least one week per month to be at the corporate center (in addition to travel requirements). International travel is anticipated.
Responsibilities include but are not limited to:
• Lead the clinical development program
• Directing human clinical trials, phases I-IV, for lead candidate in development, helping 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
• Coordinate and develop information for reports submitted to FDA, CDC, WHO, or other government, regulatory, or partner agencies
• Presentations to various external stakeholders - regulators, governing/harmonization bodies, principle investigators, scientific conference attendees, advisors and opinion leaders
• Knowledge of clinical trial conduct to support operational needs for planning and executing clinical trials, including adherence to protocols, safety reviews, assay development, training, and clinical document review
• Planning, reviewing and editing Clinical Study Reports
• Providing input on the design of preclinical studies supporting clinical strategy
• Manage key external technology partnerships
• Other duties as assigned
• MD with vaccine product development and experience across stages of clinical development
• Minimum of 5 years' experience in pharmaceutical, biologics, or biotech R&D environment, or in a 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 and EMA
• Self-starter who will move forward with key initiatives without being prompted, able to perform a myriad of tasks needed to support the clinical development program
• Evidence of effective leadership skills
• Good verbal and written communication skills
• Ability to work cross-functionally
Novavax offers a base salary, annual bonus, equity grants, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.
Equal Opportunity Employer/Veterans/Disabled
Novavax is an equal employment opportunity employer. Employment and advancement opportunities are available to all individuals on an at-will basis, regardless of their race, color, national origin, religion, ancestry, citizenship status, military or veteran status, sex, sexual orientation, gender identity or expression, age, marital status, family responsibilities, pregnancy, disability, genetic information, protective hairstyle, or any other characteristic protected by applicable federal, state, or local law.
Except where prohibited by applicable state law, this position requires that you be fully vaccinated against COVID-19 unless you need a reasonable accommodation or qualify for an exemption.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
Gaithersburg, Maryland, USA
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