Innoviva Specialty Therapeutics
Director, Clinical Operations
Innoviva Specialty Therapeutics, Waltham, Massachusetts, United States, 02254
Company Overview:
Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc., is a biopharmaceutical company developing and delivering innovative therapies in critical care and infectious disease. Our approved treatments are indicated to address high unmet medical needs for serious conditions, and our investigational therapies are in development for patients fighting drug-resistant pathogens. Innoviva currently has three marketed medicines - GIAPREZA® (angiotensin II) for the treatment of refractory hypotension in adults with septic or other distributive shock , XERAVA® (eravacycline) for the treatment of complicated intra-abdominal infections (cIAI), and XACDURO® (sulbactam for injection; durlobactam for injection), a new treatment for hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex. Our investigational therapy, Zoliflodacin is a potential first-in-class, orally administered, single dose antibiotic with a novel mechanism of action that is currently in development for the treatment of uncomplicated gonorrhea. At Innoviva Specialty Therapeutics, Inc., we are building a culture dedicated to delivering products that address critical medical needs. If this is your passion, come and join us to make differences for patients.
Summary of Position
:
The Director of Clinical Operations Position will be responsible for the operational management, planning, oversight and execution of all ongoing clinical trials. The successful candidate will immediately assume leadership for the execution of three simultaneous clinical trials for high unmet medical need indications. This leader of Clinical Operations will directly manage program level responsibilities, including budget, timeline, and forecasting of all clinical trials.
Responsibilities
:Lead aspects of assigned clinical trials, including development of clinical operation plan and timelines based on Clinical Development Plan.Ensure consistency in processes and drive Clinical Operations performance.Responsible for oversight of Contract Research Organizations (CROs)/study vendors, including evaluation, selection, and management of CROs/vendors to ensure successful clinical trial implementation and execution. and ensure proactive management of CRO performance.Oversee the development of and adherence to clinical trial project timelines.Coordinate relevant and timely exchange of information / materials (e.g., subject enrollment, site selection/feasibility, and data collection).Coordinate with CMC team regarding drug forecasting and supply of drug products to sites and contribute to design and packaging of supplies for clinical programs and trials.Ensure monitoring plans are in place and by participating in data review.Adhere to clinical trial budgeting process.Collaborate with internal and external team members to ensure the successful conduct of clinical trials in accordance with state/federal regulations, GCP, ICH and internal SOPs.Represent Clinical Operations on cross-functional program teams for all assigned programs.Develop and implement processes across operations functions to ensure proactive inspection readiness.Contribute to authoring/co-ordination of clinical study protocols, informed consent forms (ICFs), clinical study reports (CSRs), sections of regulatory documents such as Investigators' Brochures, briefing books, safety updates, IND submission documents, responses to Health Authorities' questionsExperience & Education:
Bachelor of Science in life science/related field is required. Advanced degree is preferred.10 plus years of pharmaceutical industry experience, including a thorough understanding of drug development in early phase trials.5 plus year of experience in clinical operations at managerial level. Proven success in leading and coordinating cross-functional clinical operations teamsSkills and Abilities:
Experience with management and oversight of clinical vendors and CRO'sStrong project management, budget, forecasting and communication skills.Experience across all phases of clinical development.Excellent interpersonal, negotiation and influencing skills.Thorough understanding of country-specific, FDA (and equivalent), ICH and GCP guidelines as well as cross functional clinical processes including data management, pharmacovigilance, biostatistics, medical writing, and regulatory affairs.Experience with leading, inspiring, coaching and mentoring teams.
Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc., is a biopharmaceutical company developing and delivering innovative therapies in critical care and infectious disease. Our approved treatments are indicated to address high unmet medical needs for serious conditions, and our investigational therapies are in development for patients fighting drug-resistant pathogens. Innoviva currently has three marketed medicines - GIAPREZA® (angiotensin II) for the treatment of refractory hypotension in adults with septic or other distributive shock , XERAVA® (eravacycline) for the treatment of complicated intra-abdominal infections (cIAI), and XACDURO® (sulbactam for injection; durlobactam for injection), a new treatment for hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex. Our investigational therapy, Zoliflodacin is a potential first-in-class, orally administered, single dose antibiotic with a novel mechanism of action that is currently in development for the treatment of uncomplicated gonorrhea. At Innoviva Specialty Therapeutics, Inc., we are building a culture dedicated to delivering products that address critical medical needs. If this is your passion, come and join us to make differences for patients.
Summary of Position
:
The Director of Clinical Operations Position will be responsible for the operational management, planning, oversight and execution of all ongoing clinical trials. The successful candidate will immediately assume leadership for the execution of three simultaneous clinical trials for high unmet medical need indications. This leader of Clinical Operations will directly manage program level responsibilities, including budget, timeline, and forecasting of all clinical trials.
Responsibilities
:Lead aspects of assigned clinical trials, including development of clinical operation plan and timelines based on Clinical Development Plan.Ensure consistency in processes and drive Clinical Operations performance.Responsible for oversight of Contract Research Organizations (CROs)/study vendors, including evaluation, selection, and management of CROs/vendors to ensure successful clinical trial implementation and execution. and ensure proactive management of CRO performance.Oversee the development of and adherence to clinical trial project timelines.Coordinate relevant and timely exchange of information / materials (e.g., subject enrollment, site selection/feasibility, and data collection).Coordinate with CMC team regarding drug forecasting and supply of drug products to sites and contribute to design and packaging of supplies for clinical programs and trials.Ensure monitoring plans are in place and by participating in data review.Adhere to clinical trial budgeting process.Collaborate with internal and external team members to ensure the successful conduct of clinical trials in accordance with state/federal regulations, GCP, ICH and internal SOPs.Represent Clinical Operations on cross-functional program teams for all assigned programs.Develop and implement processes across operations functions to ensure proactive inspection readiness.Contribute to authoring/co-ordination of clinical study protocols, informed consent forms (ICFs), clinical study reports (CSRs), sections of regulatory documents such as Investigators' Brochures, briefing books, safety updates, IND submission documents, responses to Health Authorities' questionsExperience & Education:
Bachelor of Science in life science/related field is required. Advanced degree is preferred.10 plus years of pharmaceutical industry experience, including a thorough understanding of drug development in early phase trials.5 plus year of experience in clinical operations at managerial level. Proven success in leading and coordinating cross-functional clinical operations teamsSkills and Abilities:
Experience with management and oversight of clinical vendors and CRO'sStrong project management, budget, forecasting and communication skills.Experience across all phases of clinical development.Excellent interpersonal, negotiation and influencing skills.Thorough understanding of country-specific, FDA (and equivalent), ICH and GCP guidelines as well as cross functional clinical processes including data management, pharmacovigilance, biostatistics, medical writing, and regulatory affairs.Experience with leading, inspiring, coaching and mentoring teams.