ORIC Pharmaceuticals Inc.

Manager

• Manage end-to-end pharmacovigilance activities for clinical trials and post-approval oncology products
• Oversee intake, assessment, processing, medical review, and reporting of ICSRs from clinical trials, adhering to established processes and timelines
• Ensure timely submission of expedited and periodic safety reports to Regulatory Authorities, IRBs/ECs, clinical investigators, and business partners
• Support preparation and submission of DSURs, periodic safety reports/listings, and updates to Investigator Brochures (IBs)
• Develop, maintain and execute Safety Management Plans for clinical studies
• Contribute to safety sections of clinical study protocols, informed consent forms (ICFs), clinical study reports (CSRs) and IND/NDA/MAA/CTAs (as applicable)
• Review clinical trial safety data and assist with data cleaning for ongoing studies
• Participate in periodic safety reviews, signal detection and risk evaluation activities
• Maintain Reference Safety Information for ORIC products and co-administered IMPs
• Support launch readiness activities including development of post-marketing pharmacovigilance processes, development and maintenance of Risk Management Plans (RMPs) and REMS (as applicable)
• Assist with preparation for regulatory inspections and audits
• Participate in internal Safety Management Teams and governance meetings
• Partner with Clinical, Regulatory Affairs, Medical Affairs, Quality, and Commercial teams
• Support safety training for internal stakeholders and investigators
• Ensure Safety Data Exchange Agreements (SDEAs) are implemented and maintained

Senior Manager, Pharmacovigilance

Director

• Build and lead Global Medical Affairs capabilities in medical communications, operations, and field medical.
• Facilitate US and global medical strategy for rinzimetostat and enozertinib.
• Lead evidence generation planning in prostate, NSCLC, and other areas.
• Provide medical leadership in scientific engagement activities and key opinion leader outreach.
• Manage pre-launch/launch activities and provide updates to management.
• Develop and lead patient advocacy strategies.
• Support competitive intelligence activities and collaborate on scientific communication points.
• Manage operating budgets and processes efficiently.

Director, Medical Affairs

• Build and lead key Global Medical Affairs (GMA) capabilities in areas such as medical communications, operations, field medical, and a robust independent scientific research assessment process.
• Facilitate the development and execution of the multi-year US and global medical strategy and plan for rinzimetostat and enozertinib, including activities related to scientific engagement and communication, internal education, and patient advocacy.
• Lead integrated evidence generation planning in prostate, NSCLC and other disease areas of interest, including development/refinement of a publication strategy/plan, an evidence/RWD generation plan, and tactical plan as part of the overall GMA plan.
• Provide medical leadership in scientific engagement activities with key stakeholders through organizing and leading advisory boards, investigator interactions, congress activities, educational presentations and peer-to-peer discussions with the goal of exchanging and communicating scientific insights to internal teams to drive strategy.
• Lead the operations and oversight of medical affairs activities in key therapeutic areas while working cross-functionally with multiple functional leaders to support pre-launch/launch activities, and provide regular updates and support to management.
• Develop and execute a strategic plan for key opinion leader outreach and insights generation by proactively establishing and maintaining strong relationships with thought leaders, academic institutions, advocacy and medical societies in the field of oncology.
• Work closely with the Clinical, CRO, and future MSL teams to provide recruitment, scientific, and engagement support to facilitate clinical trial enrolment and timelines.
• Lead Patient Advocacy strategy and planning to incorporate the patient voice and define external medical education strategies for independent grants, respectively.
• Support competitive intelligence team activities through landscape assessments, development of patient journey, and congress insights.
• Provide medical support for scientific symposia and medical congresses and collaborate across functions to develop, review, and align on key scientific communication points, educational tactics, and medical information response documents within legal and compliance guidelines.
• Support the review and approval of abstracts, manuscripts, posters, presentations, and other documents as well as internal stakeholder medical education activities.
• Provide medical strategy leadership for Expanded Access Programs (EAP) and Investigator-Initiated Studies (IIS).
• Manage operating budget, systems, processes, and future personnel efficiently to maximize ORIC resources.

Senior Manager, Pharmacovigilance

Director, Medical Affairs

Senior Director, Medical Affairs