Company Overview:

Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc., is a biopharmaceutical company focused on developing innovative solutions for patients and healthcare providers in the fields of Critical Care and Infectious Diseases. 

Our mission to deliver innovative, life-saving medicines for serious unmet medical conditions drives us every day and contributes to building a sustainable business for the long term. It also inspires our entrepreneurial culture which fosters innovation, collaboration, and a relentless commitment to the people we serve. Patients are at the center of everything we do because everyday matters. Every employee is encouraged to take initiative, explore new ideas, and turn challenges into opportunities that can potentially transform lives, especially those suffering from serious and difficult-to-treat illnesses.

Our products marketed in the U.S. include:

• GIAPREZA® (angiotensin II) is a vasoconstrictor to increase blood pressure in adults with septic or other distributive shock.
• XACDURO® (sulbactam for injection; durlobactam for injection) is a new treatment designed specifically to treat hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible strains of bacteria called Acinetobacter baumannii-calcoaceticus complex in adults.
• XERAVA® (eravacycline) is a broad-spectrum antibiotic used to treat patients with complicated intra-abdominal infections (cIAI).
• ZEVTERA® (ceftobiprole) is an approved advanced-generation cephalosporin antibiotic and the only FDA-approved cephalosporin specifically designed to treat adult patients with Staphylococcus aureus bloodstream infections (bacteremia) including those with right-sided infective endocarditis. In addition, Zevtera is approved in adult patients with acute bacterial skin and skin structure infections (ABSSSI), and adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP). 
• Nuzolvence® (zoliflodacin) for oral suspension is a first-in-class, single-dose oral antibiotic for the treatment of uncomplicated urogenital gonorrhea in adults and adolescents 12 years of age and older weighing at least 35 kg.

Summary of Position:

The Associate Director of Clinical Operations oversees the operational aspects of clinical trials, ensuring successful execution from initiation through completion. This role provides strategic input on study planning and management, monitors project timelines and budgets, and ensures compliance with regulatory requirements. The Associate Director collaborates closely with cross-functional teams to ensure that clinical trials are conducted efficiently, within budget, and in accordance with GxP (Good Clinical Practices) guidelines. The role also drives process improvements to enhance efficiency and quality, contributing to the successful delivery of clinical programs and the organization’s broader development goals

Responsibilities:

• Lead aspects of assigned clinical trials, including development of clinical operations plans and timelines based on the Clinical Development Plan.
• Ensure consistency in processes and drive Clinical Operations performance.
• Oversee and manage of Contract Research Organizations (CROs)/study vendors, including evaluation, selection, and proactively manage performance to ensure successful trial execution
• Oversee development of and adherence to clinical trial project timelines.
• Coordinate relevant and timely exchange of information and materials (e.g., subject enrollment, site selection/feasibility, and data collection).
• Coordinate with CMC team on drug forecasting, supply of drug products to sites and contribute to the design and packaging of supplies for clinical programs and trials.
• Ensure monitoring plans are in place and actively participates 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 and 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 and coordination 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.
• Provide timely and high quality oversight of clinical activities, and escalate issues to the Director, Quality and functional leadership, as appropriate.

Experience & Education:

• Bachelor of Science in life sciences or related field required; advanced degree is preferred.
• 7 plus years of experience leading end to end global clinical trials, including a strong understanding of drug development in early phase trials; international clinical trial experience preferred
• Proven experience in management and oversight of clinical vendors and CRO’s
• Experience across all phases of clinical development.
• Demonstrated success in leading and influencing cross-functional teams; experience in guiding or inspiring teams is a plus. 

Skills and Abilities:

• Strong project management capabilities including budget, forecasting and time management skills.
• Excellent interpersonal, negotiation and influencing skills.
• Strong 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.
• Excellent decision-making, analytical and strong financial management skills 
• Ability to manage all aspects of clinical trial execution 
• Must possess excellent leadership skills with proven ability to foster team productivity and cohesiveness and the ability to operate and execute effectively with limited supervision

Competencies: 

• Effective Communication 
• Critical Thinking 
• Relationship Management & Influence
• Quality Focus

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

Innoviva Specialty Therapeutics is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.