The Senior Vice President Clinical Development serves as the executive lead, providing strategic and scientific leadership for early development clinical programs, overseeing trial direction, design, execution and data interpretation from first-in-human through early proof-of-concept trials. This role will bring hands-on experience supporting FDA regulatory interactions, including review processes, regulatory responses, and alignment of clinical strategy to regulatory expectations.

The role partners closely with executive leadership, including the President of Qpex, to support Board of Directors communications, external stakeholders, and business development initiatives. Partners and collaborates effectively with. Project Leadership/Management, Clinical, Regulatory, Pharmacovigilance, Biometrics, Medical Affairs and Commercial teams within the global Shionogi group companies, including but not limited to Shionogi Inc. (SI), Shionogi & Co. Ltd. (SHQ) and Shionogi Europe (SBV). Contributes to the development and execution of an integrated development strategy to advance the company’s pipeline efficiently while ensuring compliance with applicable FDA regulations, GCP, and ICH guidelines.

Primary Duties and Responsibilities include:

• Responsible for leading the transition of all compounds within the company portfolio from research into clinical development, including early clinical strategy and the design and oversight of early phase clinical trials (Phase 1-2a)
• Acting as the medical monitor for all early phase clinical studies and reviewing/finalizing the clinical study reports for regulatory submission.
• As needed, provide Clinical Development leadership to late-stage trials of compounds within the company portfolio in collaboration with cross-functional teams within the parent company, Shionogi, Inc.
• Interface closely with Research/Discovery and Nonclinical team to provide clinical input to Research Strategy and inform Nonclinical strategy for development candidates within the company portfolio
• Represents the Clinical function, via presentations and written reports, in various contexts involving company stakeholders such as Board of Directors, collaboration partners and government contract agencies.
• Demonstrate exceptional communication and executive presence in both internal and external settings, effectively representing Qpex and its clinical development programs with professionalism, strategic influence, and scientific credibility.
• Partners with Regulatory Affairs colleagues at the parent company to develop regulatory strategy for company compounds as well as author and review regulatory submissions and responses in collaboration with cross0functional teams.
• Accountable for clinical sections of documents for regulatory submissions.
• Drives the formulation of overall strategy and scientific direction for Early Development; establishes goals for functional areas of responsibility.
• Maintains relations with scientific and medical community including key opinion leaders.
• Allocates resources to accomplish program objectives. Ensures that on-going projects meet company scientific objectives and progress as planned, monitors and evaluates completion of tasks and projects.
• Develops and maintains high standards for personnel performance and coordinates periodic assessment of performance with concomitant merit increases, promotions and corrective actions.
• Follows SOPs appropriate to functional level.
• Manages employees in the Clinical Development and Clinical Operations Departments. Is responsible for the overall direction, coordination, and evaluation of these employees.
• Development of the strategic staffing plan in support of the business initiatives.
• Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Knowledge, Skills & Abilities Required:

• M.D. and a minimum of 15 years99 experience in the biotechnology or pharmaceutical industry managing clinical drug development, with at least 5 years in a leadership role. Experience interacting with regulatory agencies, and Investors/Board of Directors required.
• Therapeutic area focus: Infectious Disease or Pulmonary Medicine; anti-bacterial or anti-fungal experience and/or PhD in a relevant field a plus
• Previous experience managing multiple early clinical research programs with experience/ providing oversight for risk assessment, patient safety processes required.
• Ability to communicate complex scientific concepts across internal and external audiences, and the ability to influence cross-functional teams
• Established strategic leadership track record with evidence of excellent people management experience, problem solving, collaboration, and cross functional leadership
• Excellent working knowledge of FDA regulations, Good Clinical Practice, ICH guidelines, and clinical drug development
• A demonstrated record of scientific accomplishments and a proven ability to achieve results, experience with supervising projects, excellent knowledge of clinical drug development and latest regulatory guidelines.
• Excellent verbal and written communication skills and professional presentation skills.
• Must be willing to be 2hands on2 and delve into details

Additional Information

The base salary range for this full-time position is $350,000 - $400,000. 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, bonus, long-term incentive, applicable allowances, or any additional compensation that may be associated with this role.