About INOVIOINOVIO is a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from infectious diseases, cancer, and diseases associated with HPV. Our DNA medicines in development are delivered using our proprietary smart device to produce immune responses against targeted pathogens and cancers. For more information, visit www.inovio.com.Job summaryAs the leader in DNA medicines, INOVIO is currently actively engaged in the discovery, development, and commercialization of immunotherapeutic products in the areas of Oncology, HPV, and infectious diseases.
In this fast moving, innovative environment, the Senior Vice President, Early-Stage Clinical Development will have a broad spectrum of responsibilities for development of strategies that lead to successful clinical efforts to optimize and expand INOVIO's innovative product portfolio and pipeline with a robust immunology and biomarker focus. As appropriate, the Senior Vice President, Early-Stage Clinical Development will provide strategic leadership to the clinical team through sound leadership skills including communication of Clinical Development goals cross-functionally and budget oversight for the project(s).The Senior Vice President, Early-Stage Clinical Development is a key member of the Clinical Development team and is instrumental in formulating clinical strategy and the path to approval for early-stage clinical studies by designing, preparing, organizing, and implementing the Clinical Development Plan and partnering with all corporate leadership. This position will report directly to the Chief Medical Officer (CMO).The Senior Vice President, Early-Stage Clinical Development will interface with a number of key internal functions, external development partners and third-party service providers.
The individual in this role will have a strong strategic impact on INOVIO's overall clinical and pre-clinical efforts and broader corporate strategy. In addition, the Senior Vice President, Early-Stage Clinical Development represents the company in front of the scientific community and regulatory agencies in the specific area(s) of expertise in the U.S and internationally.Essential job functions and duties* Provide therapeutic areas expertise and drive integrated development strategy for INOVIO's early stage portfolio* Provide strategic leadership to cross-functional project teams (Immunology; Clinical Operations, data management, biostatistics, pharmacovigilance/safety and CMC) and ensure that operational aspects of strategic and clinical projects are appropriately implemented to support the scientific objectives within budgetary and time constraints* Provide medical and scientific oversight of current and future clinical trials (phase 1-2) for INOVIO's pipeline* Serve as a key contact and medical spokesperson for all early-stage product development related projects* Serve as a liaison with key opinion leaders and clinical investigators in related therapeutic areas* Member of the INOVIO's Senior Leadership Team* Establish and approve the design of clinical protocols, including research methods, to ensure scientific review of data, and lead the preparation of final reports* Responsible for budgets, schedules and performance requirements* Facilitate open discussions and debate among key stakeholders in a fast-paced dynamic environment* Work with Regulatory Affairs colleagues in interfacing with regulatory agencies (FDA, EMA, others) on all clinical issues* Perform complex data analysis and translate into actionable insights* Other responsibilities may be required based on business needsMinimum requirements* M.D. or foreign equivalent, including certifications with completion of specialty training* Minimum 10-15 years of experience in discovery, development, and commercialization of immunotherapeutic products in the areas of Oncology, HPV, and infectious diseases* Significant experience in related therapeutic areas to INOVIO's portfolio* Significant knowledge and experience in the design and execution of early-stage clinical trials* Demonstrated accomplishments as illustrated by successful IND, NDA, BLA or MAA submission; and be well versed in current regulatory environments* Strong communication skills: ability to facilitate open discussion and debate among key stakeholders* Very strong strategic skills including creativity and effectiveness in proactively identifying and addressing challenges* Possess a strong understanding of statistical concepts, data management, adverse event tracking and reporting, and appropriate statistical methods* Have experience in the preparation and review of documentation for regulatory submissions- including IND/CTA filings.
Experience with FDA/EMA meetings is critical* Well-organized with the ability to be flexible and prioritize multiple demands combining strategic and tactical capabilities* Travel may be required up to 25%INOVIO offers a variety of competitive compensation & benefits to regular full time INOVIO employees including:* 401(K) retirement plan with Corporate Matching* Annual Incentives* Medical, Dental, and Vision* Generous Paid-time off program and company holidays* Hybrid work environment (Depending on the nature of your employment with INOVIO)* Physical, Mental, & Financial Wellness Program* Company-paid Life Insurance plans* Long & Short-Term Disability* Flexible Spending accounts for medical and dependent care expenses* Employee Discount Perks and so much more…The annualized base salary range for this role is $395,000 to $455,000 and is bonus eligible. Individual pay decisions ultimately depend on various factors including, but not limited to, relevant experience, knowledge, skills, education, geography, internal equity and alignment with external market data.DisclaimerINOVIO Pharmaceuticals, Inc. is committed to a policy of equal employment opportunity.
In keeping with our policy, INOVIO will recruit, hire, train and promote into all job titles the most qualified individuals, without regard to race, color, creed, gender, gender identity and expression, religion, marital status, registered domestic partner status, age, national origin or ancestry, military or veteran status, physical or mental disability, medical condition including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.A current US work authorization is required. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.
All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. INOVIO offers an attractive benefits package and is an equal opportunity employer.Important notice to employment businesses/agenciesINOVIO does not accept referrals from employment agencies unless written authorization from the INOVIO Human Resources department has been provided. In the absence of written authorization, any actions undertaken by employment agencies shall be deemed to have been performed without our consent and therefore INOVIO will not be liable for any fees arising from employment agency referrals in respect to current or future position vacancies at INOVIO.