Director, Clinical Science

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 bacteria called Acinetobacter baumannii-calcoaceticus complex. Our investigational therapies in Phase III development include zoliflodacin, an investigational, first-in-class oral antibiotic for the treatment of uncomplicated gonorrhea infection in patients. 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, Clinical Science collaborates with the VP, Clinical Development to advance the innovative clinical strategic programs, supervise the design and execution of clinical trials, and to coordinate and monitor clinical trials ensuring compliance with ICH/GCP and federal regulations and collaborating with other functions to advance the IST portfolio for regulatory approvals. The Director Clinical Development is also a key leader in the execution of high-quality documents in clinical NDA sections, annual reports and periodic safety reports.

Responsibilities:

• Provide clinical development expertise and leadership to the clinical development program in conjunction with other relevant functional areas to steer trial strategies and to operationalize efficient and high-quality trial conduct
• Supervise design and review of protocol synopses, clinical trial protocols and protocol amendments
• Provide clinical development oversight of multiple clinical trials and provide input and guidance on scientific, clinical and safety monitoring issues
• Work with both external and internal stakeholders for successful clinical trial execution
• Establish, lead, and manage relationships with key external stakeholders (industry partners, key opinion leaders, health authorities)
• Represent the team to decision/governance meetings, senior management, or advisory boards as applicable
• Interface with US/international regulatory authorities, as appropriate, in the development objectives and assist in the compilation of submissions and responses to inquires
• Ensure compliance with SOPs, ICH, GCP and other national and international regulatory requirements
• Conduct review of trial data
• Collaborate and contribute to clinical study reports, other required reports, conference abstracts and presentations
• Ensure preparation of clinical sections of key documents including IBs, DSURs, annual reports, IND summaries, and IRB and Ethics responses
• Deliver clinical expertise and oversight to relevant documents for NDA submission
• Work with the matrix team to secure NDA approvals

Experience & Education:

• PharmD or other advanced degree is minimum requirement
• 5 plus years of pharmaceutical/biotechnology industry experience in clinical development
• End-to-end clinical trial experience

Skills and Abilities:

• In depth knowledge of drug development process and oversight of clinical trials
• Working knowledge of biostatistics, regulatory, clinical pharmacology and pharmacokinetics
• Ability to manage multiple tasks and prioritization skills
• Excellent interpersonal and communication skills (written and verbal)

High level of comfort and demonstrated successes working in a matrix environment, including contributing to establishing clarity and structures and driving state of the art collaborations with external academic and industry partners

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.