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. 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!
EXECUTIVE DIRECTOR, [Deputy Head of Safety/Pharmacovigilance Dept] The Executive Director
[Deputy Head of Safety/Pharmacovigilance Dept] will serve as the Lead Product Safety Physician for multiple (or large) complex, strategically important developmental programs (often multi-indication).S/he will supervise other Drug Safety Physicians and, with the support of Safety Scientists, identify and manage the documentation and communication of safety concerns.The Executive Director, together with the teams engaged in our sponsored studies, is charged with ensuring the safety of our patients.
Key Responsibilities: - Serves as Deputy to Head of Safety and Pharmacovigilance Department with direct oversight of the Drug Safety Physicians team
- Provide strategic consultation, guidance and oversight for safety sections of all regulatory documents, including but not limited to NDA/BLA/MAA, EU Risk Management Plans/REMS, PSUR/PBRERs, DSURs, ICFs, public presentations and key scientific articles and abstracts.
- Develops and provides strategy, vision, and direction to Drug Safety Physician Team
- Partners with executive leadership team for the function to provide cohesive direction towards company goals
- Provides input to executive management on drug safety
- Oversees Drug Safety Physician team to solve company-wide matters
- Accountable for oversight of benefit/risk safety profile of Ionis products through the product lifecycle
- Actively leads and enhances knowledge of safety profiles for allocated products, including both Ionis and competitor products
- Identifies and actively leads management of safety concerns for developmental and approved company products
- Actively leads product teams in the identification of, and handling of product safety concerns
- Interacts with internal and external stakeholders, normally at the senior management level, requiring negotiation of extremely critical matters
- Have a good understanding of safety operations and ensure all relevant SOPs and systems/ processes including vendor oversight responsibilities are in place making for an efficient and compliant organization
- This leader will be expected to roll-up their sleeves and help achieve targets in addition to managing direct reports
Governance: - Chairs Safety Management Team (SMT) meetings for assigned products, reviews SMT materials, and develops and represents safety perspective in SMT meetings
- Represents the SMT in the Safety Oversight Committee (SOC) meetings; develops and proposes review topics and prepares meeting materials
- Actively leads communication of recommendations to labeling group/other stakeholders
- Actively participates in meetings as required in External Safety Monitoring Committees (i.e., Development Management Committee or DMC) meetings through provision and review of safety data, insights and leadership and provides input to DMC Charters
Product Labeling: - Actively leads the development and maintenance of the Company Core Safety Information (CCSI), proposes edits and manages approval of amendments
- Presents the CCSI to the labeling committee, contributes viewpoint to Company Core Data Sheet (CCDS) development, and reviews final CCDS and associated product labels
- Provides safety insights to development of Package Insert and Labeling Updates, develops labeling update impact summaries for use by RA, develops labeling prose text updates, based on internal aggregated reports
Issues Management: - Leads and manages escalation of potential issues to the SMT, ensures internal notification and provides updates
- Leads and develops strategy for issue management and facilitates internal approval of plans
- Leads the review of safety issues data and closure on recommendations, leads the drafting of an issue response document, reviews, and manages approval of issue response documentation and responses
- Leads the formulation of a rapid response procedure, triage of potential issues to Safety Oversight Committee, executes Crisis Management response plan, reviews ongoing issue and plan
- Reviews Regulatory and other Health Authority inquiries with the Drug Safety and Safety Scientists teams strategizing the nature of response, best course of action and determines data specifications; reviews relevant data required for response
Commercialization Support and Liaison with Other Functions: - Leads and develops strategic plans for safety differentiation of company products, provides training to employees on product safety profiles/issues, provides input into commercial publications strategy, reviews publications, including abstracts, manuscripts, and speaker presentations, provides input for potential in-licensing opportunities as requested
- Product liaison for assigned products with Legal, Bus Dev, Operations, Marketing, etc., executes appropriate communication of safety data and interpretation to external parties, globally, and facilitates communication with business partners and medical directors in Medical Affairs as required.
Clinical Trial Safety Support: - Accountable for safety data, reviews and provides advice on Safety Endpoints, safety related inclusion and exclusion criteria data to capture during trial, key review activities and timing, reviews and leads input on product program wide safety issues, protocols, and protocol updates
- Accountable for the content of safety sections of the Development Safety Update Report (DSUR) - reviews and approves
- Accountable for development and maintenance of RSIs; contributes to the safety sections of the IB, ICF and updates and manages any needs to reconsent subjects in ongoing trials based on emergent safety data assessment
- Actively leads safety/PV review of statistical analyses plans and all additional analyses required for NDA/MAA applications, as well as regulatory responses; aligns with safety scientist leads in ensuring output generation for TLFs are in conformity withthe SAP
- Provide strategic leadership in safety surveillance for clinical development programs.
- Lead negotiations related to drug safety and risk management in pharmacovigilance agreements.
Developmental Product Safety Monitoring and Surveillance (Protocol Specific): - Accountable for output/summary report for inclusion into clinical filings
- Accountable for daily, weekly, and monthly review of SAEs and abnormal labs, protocol specific review of aggregate SAEs and specific analysis of aggregate data (AE tables, shift tables, listings)
Submission Filing Safety Support: - Proactively reviews and interprets study safety data, supports Clinical Study Report narrative generation, leads the interpretation-based safety sections of reports; reviews/drafts reports
- Accountable for drafting the safety sections of the Summary of Clinical Safety and ISS
- Leads 120-day update plans and activities
Extra-Departmental Liaison & Coordination: - Represents and promotes safety at the product development team as core team member, contributes to development strategy for allocated compounds
- Leads the preparations for, and attends, clinical team meetings
- Actively contributes to the development of differentiation of our products, provides training guidance to marketing training materials, reviews, and contributes to marketing materials
Compliance, Standards, Training & Project Management: - Actively leads the evaluation of current processes and assesses alignment with regulatory expectations, guidelines, and mandates for regulatory inspections
- Trains and mentors Safety Physicians and Safety Scientists
- Actively leads and maintains an environment of continuous improvement within the team and contributes to continuous improvement initiatives across GPS
Key Requirements - MD (or internationally recognized equivalent) plus accredited residency
- At least 15+ years' pharmaceutical/biotechnology industry experience in Clinical Research, Clinical Development in all phases of clinical trials, and at least 10+ years' experience in patient safety and pharmacovigilance.
- At least 10+ years prior experience as a lead product safety physician with global experience
- Prior experience of global regulatory interactions, including the successful submission and approval of BLA/NDA/MAA and JNDAs in a leading role
- Pharmaceutical product development experience, including individual study design and filing plans.
- Recognized as an influential leader and mentor, with proven ability to influence company strategy/direction through excellent communication and persuasion skills
- Appropriate experience with Regulatory Agency and KOL interactions
- Experienced in global regulatory requirements for pharmacovigilance
- Demonstrated leadership skills, and an ability to uphold behaviors that are in alignment with our Culture, Core Principles, and Working with Each Other policy
Please visit our website, for more information about Ionis and to apply for this position; reference requisition# IONIS003271
Ionis offers an excellent benefits package! Follow this link for more details:
Ionis Benefits Full Benefits Link:
The pay scale for this position is $244,055 to $363,771
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.
Job Tags
Remote job, Shift work,