Director​/Sr. Medical Director, Drug Safety Waltham, MA

Company Overview:

Mythic Therapeutics is a privately held, clinical stage product-platform company building a pipeline of best-in-class antibody drug conjugates (ADCs) exhibiting a combination of unprecedented efficacy and therapeutic index. The Company’s Fate Control™ engineering technology dramatically enhances ADC uptake in tumor cells with less impact on healthy cells, thereby safely increasing efficacy and opening up new therapeutic opportunities against a broad array of tumor targets.

At Mythic Therapeutics, we approach our work as entrepreneurs and innovators, blazing new trails that lead to better patient outcomes. We do so decisively and thoughtfully, drawing upon the decades of experience within our leadership team and scientific advisers. If you share our passion and sense of urgency for developing effective cancer treatment options, and are looking for a dynamic, collaborative, and fulfilling work environment, we invite you to explore opportunities to join our team.

Together, we are re-envisioning cancer therapy.

The Director/Sr. Medical Director, Drug Safety & Pharmacovigilance (PV), is responsible for:
1) the collection, detection, assessment, monitoring, and prevention of adverse effects with Company’s drug candidates; and
2) the strategic development and oversight of the Company’s Pharmacovigilance function/program and is accountable for the design and implementation of the PV infrastructure to support a variety of core medical activities including the management of safety signal, risk management, and benefit-risk strategies for Mythic’s pipeline of novel ADC therapeutics. The role will provide input and overview on PV regulatory documents and strategy in compliance with all relevant regulatory requirements.

This role will have responsibility for all internal and outsourced PV activities and will be a key member of the Product Development Team (PDT).

This position will report directly to the Chief Development Officer.

• Reviewing and evaluating adverse event reports (AERs) to determine if they meet regulatory reporting requirements. Assist in the preparation of safety reports to be submitted to regulatory agencies.
• Monitor and assess the risks and benefits of Company’s drug candidates to patients. Lead the development and execution of risk management plans.
• Liaise with Data Management and Clinical to ensure integrity of safety data. Collect additional information on adverse events from healthcare professionals/investigational sites and other stakeholders as needed. Communicate with regulatory authorities, healthcare professionals, and other stakeholders on safety-related issues.

• Long-term strategic planning for PV (e.g.,Creation of PV roadmap and budget, inclusive of PV Organization and the components of PV Infrastructure, define needs, cost, and triggers for specific milestones).Provide strategic advice for the delivery of PV related study support for all clinical trials.
• Participate in the development and implementation of safety policies and procedures. Author required PV SOPs and review non-PV SOPs with PV touchpoints.

• Facilitate and support the build of PV QMS including SOP development, inspection readiness, metrics development, and governance structure.
• Lead development (e.g., advise data package, oversee authoring, review, and approval) of Safety/PV regulatory documents (e.g., DSUR) and strategy per global regulations.
• Monitor safety literature (develop search strings, execute, and review literature search outputs) to stay current on the latest safety information related to the company's drug candidates for the purpose of aggregate safety reporting.
• Co-lead the preparation of internal (e.g., Safety Review Meeting) and external (e.g., DSMB) safety governance meetings with Data Management and Clinical.

• Collaborate with other departments such as clinical research, regulatory affairs, etc, to ensure compliance with safety regulations and guidelines.

• Education:
  
  MD from accredited institution of Medical Education (board certified preferred; board eligible or OUS equivalent) or equivalent required
• Experience:
  
  Over 5 Years relevant experience…