Director, Safety Science
Arrowhead PharmaceuticalsAbout the role
Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.
Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
The Position
The Director, Safety Science provides leadership to other safety scientists and scientific support in managing the development, implementation and oversight of Arrowhead investigational products.
Responsibilities
- Lead a group of Safety Scientists across Arrowhead’s Therapeutic Areas.
- Supervise the Safety Scientists activities and approve documents and deliverables.
- Train Safety Scientists and contribute to individual scientists projects and goals
- Monitor Safety activities and active membership in TST (Trial Safety Team), PST (Program Safety Team) or other Safety Governance activities.
- Review potential safety observations, safety signals and contribute to the Safety Governance process through the preparation and presentation of safety data; prepare and assess safety data for ongoing periodic, aggregate safety data reviews, and provide recommendations for review and approval by the Executive Safety Committee
- Prepare periodic aggregate safety reports including DSUR, FDA IND Annual Report etc.
- Performs routine signal detection, trend recognition in blinded and unblinded patterns for clinical trials and contribute to signal detection from the internal safety database and literature reports
- Identifies and evaluates safety signals through assessment of individual case safety reports and aggregate data
- Able to give presentations of safety data to intradepartmental and interdepartmental audiences
- Lead and facilitate department meetings; prepare agendas and meeting minutes; assist with vendor management and oversight
- Vendor management, budget review and CRO project coordination
- Keeping updated on relevant regulations associated with the above activities
- Collaborate with cross-functional team members across the matrix
- Oversee CRO vendors who perform local safety reporting for Arrowhead
- Develop and update of Clinical Risk Management Plans for clinical studies he/she will be responsible for
- Review and monitor SAE/SUSAR case processing including, performing the secondary quality review for all case reports in the safety database for the responsible Arrowhead programs
- Supports the preparation and maintenance of safety sections of the Clinical Protocols, Clinical Study Reports the Company Core Data Sheet and Risk Management Plan
- Prepare and update study-specific Safety Monitoring Plans and study reporting matrix as needed
- Provide drug safety case management support to medical monitors; assist in following up on queries for case reports, abnormal laboratory values, or any other relevant safety and medical data for various Arrowhead programs
- Assist in compiling safety data required for DSC and DSMB meetings for Arrowhead clinical studies
- Monitor SAE reconciliation with the Arrowhead PV vendor and study CRO to ensure effective reconciliation process
- Liaise with other company departments including, Clinical Operations, Quality, Regulatory, etc., and provide drug safety support
- Review and development of written materials including clinical trial protocols, Informed Consent Forms, Case Report Forms, adverse event (AE)/ serious adverse event (SAE) reporting forms, Cl
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