DIRECTOR, CLINICAL OPERATIONS

Company is a biopharmaceutical company with strong commercial and medical capabilities dedicated to providing innovative therapies to people impacted by acute and life-threatening illnesses. Company’s current portfolio includes seven commercial stage products and one investigational product under review by FDA: BAXDELA® (delafloxacin), KIMYRSA® (oritavancin), MINOCIN® (minocycline) for Injection, ORBACTIV® (oritavancin), REZZAYO™ (rezafungin for injection), TOPROL-XL® (metoprolol succinate), VABOMERE® (meropenem and vaborbactam), and cefepime-taniborbactam. With an unsurpassed commitment to providers and patients, Company is dedicated to saving lives threatened by the global public health crisis of infections. We are small but mighty, with an unsurpassed commitment to patients, one another, and the business. We strive to offer a dynamic work environment, in which innovation, teamwork, knowledge and flexibility are valued.

Company’s portfolio has the unique ability to offer providers and patients a range of solutions that can meet the tremendous need for treating serious infections.

Position Summary

Leading the Clinical Operations Team and reporting directly to the VP, Head of Drug Development, this position is responsible for developing and executing clinical development plans and strategy for Company’s portfolio of products. Responsible for clinical project planning and execution, which includes, but is not limited to, timeline and budget management, identification of project risks and contingency planning, preparation of study related materials, supervision of study related activities, and authoring of study protocols and reports.

Key Responsibilities

·       Lead Clinical Operations Team to drive and execute strategy in alignment with corporate goals and objectives , with focus on operational excellence, cross-functional collaboration, and innovation

·       Design, implement, and conduct Phase 1-3 clinical trials within established budgets and timelines, in compliance with GCP and appropriate regulations

·       Author/review study documents (e.g., study protocols, informed consent documents, Investigator’s Brochures, pharmacy manuals, monitoring plans)

·       Accountable for all clinical trial timelines, budget, and deliverables

·       Identify and develop strong collaborative relationships with study investigators, clinical sites, external business partners, and service providers

·       Identify and communicate potential risks associated with strategy scenarios

·       Selection, management, and oversight of CROs, vendors, and study sites

·       Facilitate collaboration with Company partners outside the US on shared studies

Qualifications

·       Minimum 15 years of experience in pharmaceutical industry with at least 10 years of hands-on managerial experience running clinical trials and managing teams.

·       Demonstrated experience leading Clinical Operations to deliver on-time, on-budget, high-quality outcomes supporting the Clinical Development portfolio.

·       Extensive experience developing and managing project and budget plans

·       Strong project management skills, including budget analysis

·       Advanced knowledge of GCPs and clinical study design

·       Experience working with CROs on global trials

·       Experience with pediatric and/or infectious disease trials preferred

Education

Bachelor’s degree in medical field (e.g., Health Science, Pharmacy or Life Sciences) from accredited college or university; advanced degree preferred

Position Type

·       Full Time

·       Hybrid schedule: three days per week in Parsippany, NJ headquarters office

Travel

Occasional travel, as required