Director, Safety Physician & Medical Monitoring

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 Director, Safety Physician / Medical Monitor will provide medical and strategic leadership for safety oversight across both marketed and investigational products, including post-marketing clinical studies. This role serves as the medical authority for product safety, ensuring proactive risk management, regulatory compliance, and scientific rigor throughout the product lifecycle. The Director partners cross-functionally with Clinical Development, CMC, Regulatory Affairs, Pharmacovigilance, Medical Affairs, and Commercial teams to ensure patient safety remains central to development and commercialization strategies.

Responsibilities

• Serve as Medical Monitor for assigned clinical trials, including post-marketing studies, providing ongoing medical oversight of patient safety, protocol adherence, and emerging safety trends.
• Conduct medical review and assessment of adverse events (pre-marketing and post-marketing), including SAEs, AESIs, laboratory signals, and special safety topics; determine causality and expectedness.
• Provide medical input into protocol development, safety monitoring plans, stopping rules, eligibility criteria, statistical analysis plans, and risk mitigation strategies.
• Lead or contribute to the preparation and review of safety sections of Investigator Brochures, protocols, informed consent forms, SAPs, CSRs, NDAs/BLAs/MAAs/CTDs, and regulatory responses.
• Prepare, review, and maintain Company Core Safety Information (CCSI) and Company Core Data Sheets (CCDS); lead determination of the Adverse Reactions section and contribute to other safety-relevant labeling updates.
• Provide medical review and oversight of aggregate safety reports, including PSURs, PBRERs, DSURs, ASRs, and integrated safety summaries.
• Assess safety issues arising from clinical trials, spontaneous reports, literature, quality complaints, or post-marketing data, and contribute to benefit-risk evaluations and regulatory decision-making.
• Collaborate cross-functionally with Pharmacovigilance, Clinical Development, Regulatory Affairs, Medical Affairs, CMC, Quality, and other stakeholders to identify, evaluate, and manage safety signals, including participation in Health Hazard Assessments and risk management activities.
• Oversee signal detection activities and provide medical recommendations for potential safety concerns.
• Provide medical expertise in responses to Health Authority queries, inspections, and senior management safety inquiries.
• Liaise with investigational sites as needed to address safety-related issues. 
• Ensure quality and accuracy of safety data within the safety database, including oversight of MedDRA and WHO Drug coding in collaboration with Data Management and PV Operations.
• Contribute to the development and implementation of project-specific procedures and medical review workflows in compliance with company SOPs and global regulatory requirements.
• Support inspection readiness, audit activities, and continuous improvement initiatives within the safety function.
• Provide expert medical advice across programs and contribute to strategic safety planning to support timely and high-quality delivery of clinical and commercial objectives.
• Perform additional duties as assigned consistent with the scope and level of the role.

Experience & Education:

• MD or DO is required. Additional advanced degree (for e.g. MPH, PhD) is a plus. 
• 7 plus years of relevant experience in drug safety, clinical safety and/or benefit-risk management within the biotechnology or pharmaceutical industry or 5 plus years with an additional advanced degree such as MPH or PhD
•  Clinical Patient Care experience preferred
• Demonstrated experience serving as a Medical Monitor in clinical development programs preferred.
• Strong knowledge of global pharmacovigilance regulations, GCP, and regulatory safety reporting requirements.

Skills and Abilities:

• Demonstrated ability to review and/or prepare scientific or regulatory documents from large volumes of scientific data 
• Strong knowledge and understanding of domestic & international PV and regulatory guidelines
• Drug safety database and MedDRA coding knowledge required
• Proficiency in Microsoft Word, Excel, PowerPoint, Outlook, and Adobe Acrobat computer skills
• Excellent communication skills (verbal and written), with the ability to convey complex medical and safety information clearly to diverse audiences.
• Highly organized, self-directed, and detail-oriented, with strong analytical, critical thinking, and problem-solving skills.

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.

 Please Note: Innoviva Specialty Therapeutics does not accept unsolicited resumes or candidate submissions from staffing agencies or recruiters. Any such submissions will be considered property of Innoviva Specialty Therapeutics, and we will not be obligated to pay any fees associated with them unless a prior written agreement is in place.