Summit Therapeutics, Inc.

Compliance

• Act independently to lead global regulatory strategies for assigned products/indications through all phases of development to include regulatory approvals/product launches, and post-marketing efforts, with little to no oversight.
• Will represent Regulatory Affairs as relates to development collaborations and/or partnerships, to include leading due diligence as required supporting BD activities
• For new indications assigned, will lead effort on behalf of regulatory cross-functionally with colleagues from clinical, biostatistics, commercial, medical affairs, clinical pharmacology, safety, and others. Expected to provide material (content) input into potential study synopses and corresponding global regulatory briefing documents.
• Continually expands TA knowledge and ensures strategic messaging and content of global regulatory dossiers, to include development of tumor landscape assessment to inform evolving development strategy.
• Advises management and cross-functional team members of the effect of current or proposed relevant laws, regulations, guidelines, and standards, etc.
• Key internal leader and driver of regulatory policy and strategy for assigned products
• Lead regulatory team in the preparation and maintenance of risk assessment and mitigation strategy development for assigned products
• Lead labeling strategy for given product(s)/indication(s), in support of initial license applications through post-marketing
• Demonstrates excellent understanding of drug development and leadership behaviors consistent with the level
• Accountable for ensuring that corporate goals are met with respect to assigned projects
• Based on experience and scientific strengths, expands TA knowledge of TA; provides coaching and mentoring for other regulatory members and extra-departmental colleagues
• Will have direct reports and contributes to the performance management for other RA team members
• May advance the organization's goals by participating and taking leadership roles in professional associations, industry, and trade groups as appropriate
• Follows budget allocations

Executive Director – Regulatory Affairs, Global

Manager

• Provide leadership and operational expertise in the execution of Phase I–III clinical trials across the US.
• Serve as the main operational contact for assigned clinical trial sites across the Tri-State area.
• Provide leadership and oversight for all operational aspects of site performance, from feasibility through study closeout.
• Recommend sites based on indication, experience, capabilities, and local knowledge.
• Drive efficiency in study start-up and expedite site activation timelines.
• Maintain deep knowledge of site capabilities, processes, and requirements.
• Act as a facilitator between Summit functions and site teams for communication and coordination.
• Track key performance metrics to assess site progress, mitigate potential risks, and implement corrective actions.

Senior Manager, Clinical Site Partner

• Support the company’s transparency reporting activities in accordance with all applicable laws and company policies for Healthcare Providers (HCPs) and Healthcare organizations (HCOs)
• Ensure correct reporting for all Transfers of Value (TOV) from the company to the reportable HCPs and support HCP dispute resolutions.
• Achieve transparency monthly, quarterly, and annual reporting deadlines with accurately reported data as well as conduct weekly data scrubbing for submission into the reporting system.
• Maintain up-to-date knowledge of Sunshine Act transparency reporting requirements to assess general data quality issues that may impact ability to report information to the applicable agencies.
• Resource for day-to-day processes related to compliance with Sunshine Act Transparency, analyze and determine the best course of action for each inquiry/problem, while producing timely reports and providing supporting documentation for audits.
• Support the implementation of transparency monitoring policies and procedures and training on them.
• Provide support in the annual certification process.
• Partner with multiple stakeholders throughout the Company (e.g., Legal, Clinical Operations, Medical Affairs, Sales and Marketing, HR, Internal Audit, QA) to manage and enhance an effective corporate compliance program and function and ensure that appropriate compliance policies, procedures, and internal controls are in place.
• Develop, maintain and regularly assess key policies and procedures to mitigate identified risks and meet government and healthcare compliance requirements.
• Ensure curriculum and training plans align with business needs and regulatory/legal requirements.
• Understand relevant laws and regulations in key global markets to ensure that the Company’s policies and business practices align with such laws and regulations.
• Assist with monitoring, auditing and enforcement of compliance efforts, including compliance monitoring activities; risk assessments and reviews of compliance risk areas to determine risk exposure; ongoing collaboration with key stakeholders to identify any issues of non-compliance; and summarize and report same to the Chief Compliance Officer or her designee.
• Conduct and manage compliance investigations regarding allegations of law or company policy or ethical standards and prepare written reports on the findings of such investigations, as directed by the Chief Compliance Officer or her designee. Assist with the determination and implementation of corrective actions.
• Collaborate with the Chief Compliance Officer or her designee and global team to continue to enhance a culture of ethics and compliance.
• Serve as a resource and subject matter expert for all healthcare compliance related activities.
• Lead on other projects as assigned from time to time.
• All other duties as assigned.

Compliance Manager – Transparency

Director

• Establish, broaden, and deepen relationships with target entities (e.g., health insurers, PBM's, other payers, etc.) and key decision makers and influencers (medical and pharmacy directors, etc.) that affect coverage and reimbursement decisions.
• Positively influence decision makers, policies, guidelines, and contracts to facilitate timely and appropriate coverage, access and reimbursement for our drug candidates and approved products.
• Implement Brand access strategies and develop account specific plans and assist in the resolution of access/reimbursement issues.
• Work closely with the Medical Affairs field team to support the communication and understanding of our drug candidates and approved products with payers.
• Work closely with the Patient Services team to support the patient journey and resolve coverage issues.
• Assist Regional Sales teams with pull- or sell-through strategies based on payer coverage.
• Establish and maintain relationships with key decision-makers, including Formulary, P&T, and Pathway leaders, Medical & Pharmacy Directors and other population-based stakeholders to secure appropriate access and optimal product positioning.
• Co-create account-level strategies, tools, and tactics to communicate the product value proposition effectively. Collaborate on pricing and contracting strategies, HEOR evidence generation plans, patient support programs, payer marketing initiatives, and account management approaches.
• Lead discussions with internal and external partners to ensure alignment on access, coverage, and reimbursement strategies.
• Foster a high-performance culture within the field team by promoting accountability, urgency, ethical behavior, and professional development.
• Stay informed on healthcare industry trends, payer policies, reimbursement processes, and competitive activity. Provide strategic insights to inform decision-making, access strategies, and product launches.
• Ensure all Market Access initiatives are developed and executed in compliance with legal, regulatory, and ethical standards.
• Ability to work effectively in a fast-paced and dynamic environment, balancing multiple priorities and meeting deadlines.

Executive Director – Regulatory Affairs, Global

Senior Manager, Clinical Site Partner

Compliance Manager – Transparency

Director – Market Access, Payer Accounts