Medical Director - Clinical Development (Finance)

Overview
Qpex Biopharma is seeking a Medical Director, Clinical Development to join our dynamic antibiotic development team. In this role, you will play a pivotal part in advancing our efforts to develop novel antibiotics to address antibiotic resistance. The Medical Director is responsible for providing medical direction, management and review of clinical trials and product development. Specific tasks may include design of clinical development program plans, as well as clinical protocol development, medical monitoring of clinical trials, and analysis of study data and preparation of trial reports and related regulatory documents. This individual will have a solid understanding of all phases of clinical drug development with particular expertise in first in human/early phase clinical trials, translational science, and operational excellence. Excellent written and effective verbal communication skills, ability to influence across functions and levels, and flexibility/adaptability to work in a fast-paced environment are essential.This position reports to the Chief Medical Officer and is based in our San Diego office.
Detailed Description
Essential Duties and Responsibilities

• Drive protocol development for clinical studies in collaboration with Clinical Operations and other clinical sub-team functions
• Drive preparation of clinical development plans in partnership with cross-functional teams
• Provide strategic and operational guidance to teams, based on medical and scientific expertise and sound clinical judgment
• Assist in the preparation and review of documents for regulatory reports including drafting of clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports (DSUR), and other FDA/HA submissions
• Contribute to CSR preparation and finalization
• Contribute to development of CRFs and data review plans
• Monitor, analyze and review data in ongoing studies
• Serve as primary Sponsor medical point of contact (eligibility questions, AE management, etc) for clinical trial sites and CRO
• Present clinical study outcomes and other critical data at various meetings which include but are not limited to health authorities, academic conferences and medical congresses
• Develop/maintain strong relationships with internal and external scientific experts to help lead the company's interests from a medical perspective.
• Promote and participate in a culture of learning and continuous education, including remaining current through literature review, attendance at medical/scientific meetings, etc.
• Providing coaching and subject matter expertise to team members and colleagues

Requirements

• MD, DO, PharmD or equivalent degree with 5 years of clinical/clinical research experience in academia, industry or similar setting with a minimum of 3 years of Biopharmaceutical Industry experience; 5 years Biopharmaceutical Industry experience will be a plus
• Experience in industry in early phase development preferred
• Infectious disease training and/or practice a plus
• Clinical trial design and management experience
• Strong knowledge of GCPs and US regulatory (and elsewhere) reporting requirements for product safety
• Experience in analyzing clinical data and writing and reviewing scientific and clinical research reports for regulatory submission and scientific publication
• Strong leadership, influence, and interpersonal skills
• Demonstrated ability to work in a diverse, multi-cultural team-oriented environment
• Excellent written and verbal communication skills, including presentation skills
• Critical thinker with a solutions-oriented mindset
• Self-motivated to work effectively in a dynamic environment
• Must be available to work onsite at our San Diego office location

Additional InformationThe base salary range for this full-time position is $220,000-$265,000. Individual pay is determined by several factors, which include but are not limited to: job-related skills, experience, and relevant education or training. The range does not include the comprehensive benefits, vehicle allowance, bonus, long-term incentive, or any additional compensation that may be associated with this role.
EEO
Qpex Biopharma is an equal opportunity employer supporting individuals with disabilities and veterans. All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law. It is the policy of Qpex Biopharma to undertake affirmative action for protected veterans and individuals with disabilities in compliance with all federal, state, and local requirements to recruit a diverse pool of protected veteran and individuals with disabilities applicants and to ensure that our employment practices are, in fact, non-discriminatory. If you are qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request accommodations by calling 973-307-3550 or by sending an email to ShionogiHR@shionogi.com.