Sr. Director/Executive Director of Drug Safety & Pharmacovigilance

Skyhawk Therapeutics seeks a Sr. Director/Executive Director of Pharmacovigilance & Drug Safety to support product safety and compliance. The successful candidate will report to the SVP of Clinical Development and be responsible for managing drug safety data to support signal detection and risk/benefit profile evaluation, author safety documents, perform QC of safety documents, organize cross-functional Safety Management Team meetings. The successful candidate will oversee the ICSR data quality from safety vendors and ensure compliance with all applicable US and foreign legal and regulatory requirements to ensure compliance with global drug safety regulations while working in a highly collaborative work environment with a multi-disciplinary and diverse team, focusing on multiple programs in parallel.

Responsibilities:

Collaborate, and oversee the work of CROs directly involved in ICSR management, aggregate & periodic reporting, and business partner reporting

• Oversee adverse events handling, including ICSR reviews, assessment of expectedness and relatedness, and collaboration with Regulatory on expedited reports as appropriate for all Skyhawk products
• Provide subject matter expertise in the interpretation of regulations (FDA and ICH guidelines) as related to case processing, SAE case assessments of expectedness
• Perform quality review of completed draft narratives for SAE reports/SUSAR reports received from CROs
• Perform review of Analysis of similar events and Investigator notification for SUSAR reports
• Review/generate appropriate medical/data queries to complete/clarify SAE case information
• Oversee monthly compliance metrics with SUSAR reporting to HAs
• Review of safety management plans
• Provide SME on reconciliation of safety data in safety and clinical database
• Review safety data exchange and/or pharmacovigilance agreement with business partners and be accountable for ensuring safety data exchange activities are carried out per SDEA/PVA
• Perform review of semi-annual SUSAR listings and global risk benefit assessment prepared by CRO
• Assist in preparation of safety sections & perform review of development safety update report (DSUR) prepared by CROs
• Perform QC of safety documents as applicable

Support signal detection and risk management activities

• Provide support in periodic review of aggregate safety data for potential trends or signals in a timely manner
• Perform signal detection activities and analysis to support evaluation and characterization of safety topics for Skyhawk products
• Draft safety topic review (STR) document as needed
• Organize and facilitate cross-functional Safety Management Team (SMT) meetings for signal management, and benefit-risk assessment for Skyhawk products, prepare meeting minutes, and track actions and risk communications
• Review safety concerns escalated from internal and external stakeholders, including competent regulatory authorities, and support strategies for safety assessment in collaboration with the Head of Safety
• Review potential issues and safety signals and contribute to the Safety Governance process through the preparation and presentation of safety data
• Assist in drafting development risk management plan/risk mitigation measures as needed
• Participate in key activities of DS&PV, including safety data review, signal detection, risk communication including safety information updates, and mitigation of potential risks

 Support Development activities as a member of CTT

• Collaborate with CTTs, weekly CRO/sponsor call and monthly medial meeting call with CRO
• Review and/or contribute to safety sections of key study documents such as Investigator Brochures, protocols, statistical analysis plans, informed consent forms, and CSRs
• Support preparation of IB RSI table for IB updates in accordance with CTFG
• Support preparation for DSMB and SMC meetings
• Author/support in preparation of responses to HA/business partner(s) safety inquiries
• Participate in the drafting and implementation of pharmacovigilance contracts, agreements, and budget (CRO)

Other activities

• Assist in developing/writing Safety SOPs, Work Instructions and other guidance documents, in compliance with global safety regulations and guidelines
• Support audit and inspection readiness of the PV team at all times
• Ensure internal regulatory/PV processes and procedures are well documented and support compliant regulatory/PV activities
• Assist in preparation of response to regulatory inquiries related to safety
• Prepare training materials for internal and external safety presentations as applicable
• Perform other department duties as assigned

Education/Skills/Experience Requirements:

• Healthcare professional degree required (PharmD, RPh, NP, RN, BSN, PA)
• 10+ years of experience in drug safety/pharmacovigilance in global clinical trial setting (title will be commensurate with the candidate’s HCP background and industry experience)
• Experience in rare disease or neurology clinical safety is strongly preferred, as is small molecule biotech experience
• Expert knowledge of FDA and EU safety regulations, ICH Guidelines, Good Pharmacovigilance Practice (GVP) and other applicable safety and regulatory guidance documents
• Strong experience with drug safety databases such as Argus, and electronic data capture (EDC) systems, MedDRA and WHO Drug dictionary coding
• Oversight experience of global safety activities, operations, and risk management activities in pre-market setting
• Skilled at overseeing all PV outsourced vendor activities and in a compliance/regulated field
• Adept in managing multiple projects simultaneously in a fast-paced environment
• Team player who applies rational approach to issues and their business implications, with good problem solving and decision-making skills
• Strong interpersonal skills including verbal and written communication, with attention to detail
• Proficient in Microsoft Suite: Word, Excel, PowerPoint, Outlook
• Possesses a sense of urgency and an ability to anticipate and respond quickly to emerging information

Skyhawk Therapeutics is committed to pay transparency and equitable compensation practices. The base salary range for the Sr. Director/Executive Director of Drug Safety & Pharmacovigilance is $300,000-4450,000 annually. This range reflects the minimum and maximum target for such position. Skyhawk Therapeutics will assess the appropriate level for a qualified candidate based on job-related skills, professional experience, and relevant education or training.