Job Description

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. Were pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and 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 that our success is a direct result of the exceptional talents 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, hybrid and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive.

Were building on our rich history, and we believe our greatest achievements are ahead of us. If youre passionate about the opportunity to have meaningful impact on patients in need, we invite you to apply and join us. Experience and contribute to our unique culture while you develop and expand your career!

MEDICAL DIRECTOR - DRUG SAFETY PHYSICIAN

SUMMARY :

The Medical Director, Drug Safety Physician, collaborates with the Product Lead or Head of Drug Safety and is responsible for the clinical safety strategy for assigned drug projects and products. They provide drug safety expertise and guidance to Clinical Development, the Safety Oversight Committee (SOC), and the Clinical Project Teams, while also leading the 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 detection and 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 cross-functional teams in support of the products and Ionis business partners. This position reports to the Safety Team Lead of assigned products.

RESPONSIBILITIES :

• 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
• Provides support and is capable of leading signal detection, signal evaluation, data analysis, and benefit-risk evaluation for assigned compounds, including ability to author signal report in response to Health Authority inquiries
• Provides support and can lead risk management and risk mitigation activities, including medical and safety leadership for RMPs
• Writes individual case assessments and evaluates aggregate safety data for periodic reports as required
• 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 in order to predict / establish the safety profile of compounds in clinical development
• Offers medical judgment on complex safety issues
• Works cross functionally with clinical to determine the most appropriate monitoring and stopping rules for clinical trial protocols in partnership with the projects medical monitor
• Supports and can present safety data to DSMBs for assigned products
• Collaborates with partner companys drug safety team 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
• 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 / MAA submissions, RMP, annual reports, etc.)
• Prepares and / or reviews safety documents (DSURs, PBRERs, 6MLL, etc) 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
• 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.)
• May support and / or contribute to writing of white papers and other internal scientific publications
• Assist in accomplishing department and corporate objectives
• May participate / present safety material to Investigators 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)
• At least 5 years of clinical experience post-registration
• High level of medical competence, with an ability to balance this with industry standards to achieve business goals
• At least 5 years of Drug Development / Patient Safety experience (the majority of which should be in industry in Patient Safety) with clear evidence of delivery
• 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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