Director/Executive Director, Drug Safety Physician

Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases.

We are pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs.

With five currently marketed medicines for serious diseases and an expansive late-stage pipeline, we continue to build upon our groundbreaking innovations in science and technology to provide greater value to patients;

and we are well positioned financially to deliver on our strategic goals.

At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence.

We know our success is a direct result of the exceptional talent and dedication of our employees.

With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team.

We continue to invest time, money, and energy into making our onsite and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive.

We are building on our rich history, and believe our greatest achievements are ahead of us. We invite you to apply and join us if you’re passionate about the opportunity to have meaningful impact on patients in need, our employees, and our organization.

Experience and contribute to our unique culture while you develop and expand your career!

DIRECTOR / EXECUTIVE DIRECTOR, DRUG SAFETY PHYSICIAN

SUMMARY :

The Director / Executive Director, Drug Safety Physician is responsible for the clinical safety strategy for assigned drug projects and products, provides drug safety expertise and guidance to Clinical Development, Safety Oversight Committee (SOC) and the Clinical Project Teams, and drives proactive implementation of risk management initiatives in accordance with global regulatory requirements.

Major areas of responsibility include continuous efficient evaluation of safety data to perform signal evaluation and predict and manage the safety profile of compounds in clinical development, consistent communication of safety topics across all regulatory safety documents, and strategic collaboration with Ionis partners.

This position reports to the VP and Head of Safety & PV.

RESPONSIBILITIES :

• Leads product risk characterization and benefit / risk assessment activities encompassing proactively identifying through individual case review reports or aggregate reviews new signals, and evaluating the signals and providing risk minimization measure, and communicating those issues through Head of Safety
• Ability to put together coherent risk assessment and mitigating strategies and present with set of recommendations to the Safety Oversight Committee for feedback and endorsement
• Performs individual case report assessment and determines regulatory reporting responsibilities as required
• Provides medical review of case narratives for medical content, accuracy, and signal detection
• Interpret aggregate safety data for periodic reports and evaluating for potential new signals
• Lead signal detection, signal evaluation, data analysis, and benefit-risk evaluation for assigned compounds
• Lead risk management and risk mitigation activities, including medical and safety leadership for RMPs and aRMMs
• Provides medical input into identification and utilization of appropriate sources of information and database searches to retrieve relevant data for evaluation of signals
• Proactively evaluates the clinical implications of safety data from pre-clinical studies, clinical studies, literature, and other information sources to predict / establish the safety profile of compounds in clinical development
• Accountable for medical content and safety messaging in aggregate reports (PBRERs, DSURs, IBs) and responses to Health Authority requests, as well as capability in offering medical judgment on complex safety issues
• Determines the most appropriate monitoring and stopping rules for clinical trial protocols in partnership with the project’s medical monitor and / or medical lead.
• Presents safety data to DSMBs for assigned products
• Collaborates with partner company’s drug safety teams and clinicians, and provisions regular safety summaries
• Contributes to / reviews the Safety Data Exchange Agreements and other documents shared with partners; provides vendor oversight for assigned products
• Participates in cross-functional project teams; communicates across organizational levels and functions
• Contributes to the maintenance of the pharmacovigilance system and processes
• Participates in SOP updates, audits, and inspection readiness
• Writes / updates core safety information for assigned projects
• Writes / reviews and provides technical input for the safety sections of regulatory documents for assigned projects (i.

e., protocols, IBs, ICFs, CSRs, IND submissions, annual reports, etc.)

• Prepares and / or reviews safety documents and provides strategic input into responses to regulatory inquiries
• Participates in external regulatory and non-regulatory meetings, including those with consultants and other companies, such as licensing partners
• May assist in due diligence activities
• May provide support to Legal for product liability litigation, as appropriate
• Supports the medical coding group on an ad hoc basis
• Participates in reconciliation procedures
• Guides and / or trains external personnel / parties involved in Ionis’ clinical studies.
• Provide clinical education support for internal company customers
• Collaborates effectively in cross-functional and cross-cultural project teams and environments, and work with external providers
• Maintain clinical and technical expertise in the therapeutic areas in which Ionis operates (i.e., through review of scientific journals, attendance at scientific and key technical meetings, etc.)
• Participates in writing of white papers and other internal scientific publications.
• Assist in accomplishing department and corporate objectives
• May be required to act as medical monitor for some clinical trials
• May participate / present safety material to Investigator’s meetings and other medical meetings
• Participates in selection and bidding activities for vendors and contractors.
• Managerial responsibilities as required
• Other duties and ad hoc activities as assigned

REQUIREMENTS :

• Medical degree (e.g., MD, MBBS) and at least 15 years of Drug Development / Patient Safety experience (the majority of which should be in industry in Patient Safety) with clear evidence of delivery
• Extensive experience supporting safety filing activities, or leading activities in signal detection and supporting aggregate reports (DSUR, PADERs & PBRERs)
• Experience submitting reports of periodic review of aggregate safety data to Health Authorities in the US, UK, and Republic of Ireland
• Safety experience supporting NDA / MAA submissions
• High level of medical competence, with an ability to balance this with industry standards to achieve business goals
• A thorough knowledge of the pharmaceutical / biopharmaceutical industry, especially clinical research and global regulatory requirements, and practices governing expedited and periodic safety reporting, signal generation, safety evaluation, and risk management activities.
• Able to work across therapeutic areas and functions
• Works collaboratively (establishes shared purpose across boundaries)
• Develops people and the organization (invests in long-term development of others)

Benefits

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