Company Overview:

Innoviva Specialty Therapeutics is dedicated to bringing innovative therapies for patients in critical care and infectious disease. We endeavor to address unmet needs so physicians can deliver the best treatment for each patient. Innoviva currently has two marketed product medicines – GIAPREZA (angiotensin II) a vasoconstrictor to increase blood pressure in adults with septic or other distributive shock and XERAVA (eravacycline) an anti-bacterial for the treatment of complicated intra-abdominal infections (cIAI). In addition, Xacduro (sulbactam for injection; durlobactam for injection) co-packaged for intravenous use was approved in May of 2023 as the first pathogen-targeted antibacterial approved by the US FDA to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia, caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex. Innoviva Specialty Therapeutics is uniquely positioned to advancing solutions for the most critical and urgent infections identified by the world's leading public health organizations.

Summary of Position:

The Director/Senior Director, Safety Physician/Medical Monitor provides medical and/or operational assessments of patient safety in all phases of clinical trials and post-marketed reports to ensure subject safety and accurate interpretation of results. They will provide overall clinical and scientific leadership for one or more assets. This individual will also be responsible for leading the design, operational planning, execution and decision making for one or more clinical studies in partnership with a matrixed team. They will also perform medical review for safety events, provide medical oversight of company causality assessment, and expectedness assessment, review of MedDRA coding, signal detection, and risk management for assigned projects.

Responsibilities:

• Provide clinical development leadership on the timely delivery of the clinical program with attention to quality and scientific rigor.
• May lead and support the clinical components of key documents (e.g., Clinical Trial Protocols, Investigator’s Brochures, Clinical Study Reports, regulatory documents including INDs/CTAs, NDAs/MAAs and regulatory responses) with high quality and consistency with the clinical development plan.
• Complete all project activities accurately in accordance with IST SOPs, Project Specific Procedures, and regulatory requirements.
• Provide expert functional advice as well as assistance to other functions as needed.
• Review, update, or write company SOPs in partnership with the pharmacovigilance and clinical team related to Pharmacovigilance and clinical trials to ensure their compliance with EMA, ICH, and FDA guidelines.
• Will help lead and support regulatory filing activities and documents by providing strategic direction and editing to deliver concise, clear, data-driven and convincing rationale in all such written and verbal communications.
• Assist in the preparation and review of safety section(s) of investigator brochures, protocols informed consent forms, statistical analysis plans, clinical study reports, NDA/BLA/CTD submissions and other documents.
• Provide medical expertise and contributions to pharmacovigilance activities and priorities such as: Ad-hoc safety information/reports for inquiry response to Regulatory Health Authorities safety queries as well as from senior management including safety documentation for licensure submissions.
• Prepare Company Core Safety Information (CCSI) for marketed and investigational products and the Company Core Data Sheet (CCDS).
• May lead the determination of Adverse Reactions section of the product label; leads and support the preparation and review of other safety relevant sections of the label.
• Provide medical review of safety events (pre-marketing, post-marketing) and/or other medically related information per assigned tasks and project specific procedures.
• Provide medical review of aggregate reports (e.g. PSUR, PBRER, DSUR, and ASR).
• Provide assessment of safety issues arising in clinical trials or in the post-marketing setting and escalate those to manager and discuss the agreed approach on resolution.
• Provide assistance in the preparation and conduct of code-break activities.
• Assist with generation of project specific procedures (medical review workflow activities)
• May liaise with investigational site as necessary regarding safety issues.
• Assess and oversee the activities for monitoring adverse event reports for potential drug-safety related issues and provides recommendations when potential issues are identified.
• Collaborate with Pharmacovigilance, Medical Affairs, CMC and applicable functional specialists to identify, evaluate and manage safety signals including input in Health Hazard Assessments.
• Assist Data Management with MedDRA and WHO dictionary codes.
• Review of the case information entered in the safety database to ensure quality and accuracy of the data entered (i.e., updates and corrects MedDRA and WHO dictionary codes).

Experience & Education:

• Advanced medical degree required (e.g., MD, DO) or other international equivalents; additional training in epidemiology and/or statistics is a plus; board certification in Infectious Disease, Pulmonary Disease, Critical Care Medicine or other subspecialty a plus.
• A minimum of 3 years clinical practice after postgraduate training.
• 8 or more years of relevant experience in Clinical Safety/Pharmacovigilance and clinical trial medical monitoring in pharmaceuticals/biotech is required. Infectious Disease or Critical Care Medicine experience is a plus.

Skills and Abilities:

• Strong working knowledge of global PV requirements (e.g., US Code of Federal (CFR) regulations; European Union (EU) Volume 10 clinical trials directive; Guideline on Good Pharmacovigilance Practices (GVP) and ICH Guidelines) required.
• Strong leadership, teamwork, and interpersonal skills, with experience in a matrixed environment.
• Treats people with respect; inspires the trust of others; works with integrity and ethically.
• Experience with health authority interactions globally.
• Working knowledge of associated disciplines, including biostatistics, clinical pharmacology, formulation science, data management, and medical writing.
• Proven ability to analyze data from various sources for signal detection and trends for specific products.
• Thorough understanding of the cross functional drug development processes (Clinical Operations, Biometrics, and Regulatory Affairs) and GCP.
• Thorough knowledge of MedDRA terminology and its application required.
• Experience in the preparation and authoring of pre- and post- aggregate safety reports (e.g., DSURs, PSURs), RMPs, and RSI.

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.