Perspective Therapeutics

• Reporting to the Chief Medical Officer, provide strategic and operational leadership for biostatistics function. • Overseeing end-to-end clinical data workflows, ensuring high-quality evaluation of clinical data. • Developing and mentoring biostatistics staff for continued effectiveness and scalability. • Provide statistical leadership in the development and evaluation of study designs and methodologies. • Partner with clinical operations, data management, and statistical programming teams for efficient clinical databases. • Lead and/or oversee statistical programming and analysis activities across multiple research studies, utilizing various statistical models. • Direct the creation of analysis datasets, data summaries, and statistical reports, primarily using SAS. • Contribute to preparation and review of clinical trial deliverables like study reports and regulatory documentation.

• Lead clinical development strategy and operations for active programs • Manage cross-functional study teams and oversee design and execution of clinical trials • Serve as Medical Lead and primary Medical Monitor for clinical trials • Prepare clinical development plans and regulatory documents in support of regulatory submissions • Communicate with key external stakeholders to facilitate development and oversight of compounds • Present clinical data at relevant advisory board meetings and/or scientific meetings

• Provide strategic regulatory leadership across radiopharmaceutical clinical development programs • Develop and execute global regulatory strategies • Lead global regulatory submissions in support of clinical development, product registrations, and lifecycle management activities • Translate complex and evolving global regulatory requirements into clear, actionable strategies • Ensure regulatory alignment across functions and support the successful advancement of radiopharmaceutical programs from early development through commercialization

Role Description The Clinical Site Startup Specialist plays a pivotal role in the successful initiation of clinical trials by overseeing and coordinating all activities related to site startup. This position involves meticulous management, tracking, and facilitation of processes, from site selection through the Site Initiation Visit (SIV) phase. The specialist will be responsible for ensuring seamless execution of various tasks, including: - Regulatory document collection - Site contract and budget negotiations - IRB submissions and approvals - Equipment provisioning - Completion of a comprehensive greenlight checklist for drug release As the owner of the site’s contract and budget, the clinical site startup specialist will also be responsible for processing any amendments that are needed to site budget or contract. Qualifications - Bachelor's degree in a relevant field (life sciences, healthcare, etc.) - Previous experience in clinical trial site startup or a related field (2 years preferred) - Strong negotiation and communication skills - Experience managing clinical trial site contracts and budgets - Detail-oriented with excellent organizational and time-management abilities - Ability to work collaboratively in a team-oriented environment - Knowledge of regulatory requirements and guidelines governing clinical trials - Excellent written, verbal and interpersonal communication skills - Must be willing to travel up to 10% of the time Requirements - Collect, review, and track all required regulatory documents from selected trial sites - Ensure compliance with regulatory standards and guidelines - Engage in negotiations with clinical trial sites for contracts and budgets - Collaborate with the clinical trial manager and legal and finance teams to finalize agreements - Execute amendments to contracts/budgets as needed - Prepare and submit central Institutional Review Board (IRB) application in collaboration with the site and study team - Track local IRB submissions and approvals - Facilitate communication between Perspective, sites and IRBs to obtain timely approvals - Coordinate the provisioning of necessary equipment at trial sites - Ensure that all equipment is compliant with trial protocols and regulations - Execute a comprehensive checklist for drug release in collaboration with relevant stakeholders - Confirm that all site startup activities are completed and meet the required standards before drug release - Maintain open communication with internal and external stakeholders - Collaborate with cross-functional teams to address challenges and ensure a smooth startup process - Maintain accurate and up-to-date records of all site startup activities - Generate reports for management and project teams as needed - File all essential documents in the study eTMF Benefits - Equal employment opportunities to all employees and applicants for employment - Prohibits discrimination and harassment of any type - Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

• Provide strategic leadership and oversight of the medical writing function. • Own the end-to-end medical writing function, including planning, resourcing, execution, and delivery of documents. • Lead the development of complex regulatory documents as programs advance. • Ensure all written materials meet regulatory requirements and support inspections. • Establish best practices and document standards. • Partner closely with clinical development, regulatory affairs, and other stakeholders to ensure integration of medical writing. • Lead and mentor a team of medical writers, fostering technical excellence and accountability.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description Reporting to the Senior Vice President, Program and Portfolio Management, the Director, Program Management will be accountable for successfully driving all aspects of cross-functional asset development for one or more assets within our maturing early-stage clinical development pipeline. This newly created position comes as a result of multiple assets advancing in clinical development, as well as a number of new compounds soon expected to be entering our portfolio. Perspective Therapeutics has an immediate need for an exceptionally talented, highly-motivated, passionate program management professional with demonstrated expertise in early-stage oncology clinical drug development to join our team. - In collaboration with the compound lead, will be accountable for leading one or more cross-functional program teams driving early to mid-stage (peri-IND -> phase II/III) clinical drug development programs of high complexity. - Support asset strategy development, TPPs, protocol development/amendments, all facets of global phase I/II clinical trial conduct, regulatory agency interactions, coordination of CMC/manufacturing activities/dependencies, CRO/partner interactions, routine monitoring/reporting program status to executive management, ongoing assessment of opportunities, risks and resource needs (financial & personnel). - Assist in defining program strategies, developing multiple development options/scenarios, creating/maintaining cross-functional development plans, timelines and budgets for each program and ensure progress versus plan. - Schedule and efficiently lead recurring asset-specific, issue-driven, cross-functional program team meetings; maintain all supporting documentation (agendas, minutes, action items, timelines risk/issue logs, etc.). - Partner with globally-deployed, internal and external team members/partners (including Preclinical/Discovery, Manufacturing/CMC, Quality, Clinical Development, Regulatory Affairs, Clinical Operations and Finance). - Proactively identify and facilitate team review of program issues/risks and ensure mitigation plans are developed and implemented. - Effectively facilitate science-based business decisions. - Utilize scenario generation/analysis techniques to address diverse range of complex issues with significant business impacts. - Coordinate development of resource and budget plans across functions to ensure adequate resources are applied to the program; in collaboration with Finance colleagues, routinely track budgets/spend for all assigned programs and ensure alignment with company’s strategic objectives. - Provide input to the program prioritization process and participate in other key strategic business portfolio processes/initiatives. - Lead and/or support continuous improvement and/or transformational initiatives that address unique strategic, operational and/or tactical issues. Qualifications - Advanced degree in life sciences or other relevant discipline. - Minimum 7 years experience in biotech/pharma, preferably in the early development space, including 5 years in program/portfolio management or leadership of cross-functional matrix teams; strong preference given to candidates with experience/expertise in oncology, radiopharmaceuticals and/or successful functioning in early-stage startup/biotech environments. - Understanding of disease area and drug development pathway with the ability to contribute to strategic discussions. - Working knowledge of all related/contributing early development disciplines and functional areas. - Strong quantitative and analytical skills, working knowledge of descriptive statistics and their application, generation/use of metrics and dashboards to guide team performance. - Lead the development of critical path analyses and scenario planning. - Familiarity with various program management tools (MS Project, Excel, SharePoint or similar, PowerPoint, etc.). Requirements - Knowledge of GCP practices, FDA regulations and ICH guidelines. - Ability to thrive in driving program teams in resource-constrained, entrepreneurial, early stage start-up environments. - Ability to resolve complex problems and manage difficult stakeholder situations. - Flexibility to pivot to last minute changes as needed to ensure business continuity. - Leadership skills including situational leadership, ability to lead a team of experts and influence without authority. - Must have keen attention to detail with the ability to read and interpret regulatory requirements and industry standards and apply information to quality standards. - Curiosity, learning agility and adaptability. - Outstanding ability to communicate technical information to both technical and non-technical audiences. - Ability to focus on critical issues and balance and respond to competing short-term and long-term priorities. - Ability to manage and prioritize multiple programs to ensure on-time delivery with meticulous quality. - Ability to become well-versed with relevant medical and imaging concepts and terminology. - Ability to facilitate meetings and discussions in person and virtually. - Ability to travel up to 30%. Work Environment - May be required to sit or stand for long periods of 8+ hours a day while performing duties. - Willingness to complete safety training within allotted timeframes, and work in a team-based environment.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description The Senior Director, Clinical Development, will provide medical and scientific leadership for oncology clinical trials across pre-clinical through phase 1-4 development. This role requires strong expertise in oncology, radiopharmaceuticals, and clinical drug development to ensure patient safety, scientific rigor, and regulatory compliance across assigned programs. - Serve as a medical leader within cross-functional development teams - Contribute to clinical strategy, protocol development, and regulatory interactions - Play a critical role in advancing clinical programs toward regulatory approval - Support future commercialization while partnering closely with Clinical Operations, Regulatory Affairs, Safety, Translational and other teams as needed Qualifications - Medical Doctor (MD) degree from an accredited medical school required; Board certification in oncology strongly preferred - 5+ years of relevant industry experience, or an equivalent combination of industry experience, clinical practice, academic research, and demonstrated leadership in drug development - Demonstrated experience contributing to clinical development programs across one or more phases (Phase I–IV), preferably in oncology and/or radiopharmaceuticals - Proven ability to operate with increasing independence and accountability within cross-functional drug development teams - Experience participating in global regulatory interactions and contributing to clinical regulatory submissions Requirements - Strong working knowledge of Good Clinical Practice (GCP), FDA regulations, ICH guidelines, and global regulatory standards - Ability to apply clinical judgment and scientific rigor to complex development challenges - Excellent collaboration and communication skills, with the ability to engage effectively with both internal and external stakeholders - Strong analytical and problem-solving capabilities with a data-driven mindset - Proven ability to manage multiple complex programs and drive execution in a fast-paced, dynamic environment - Willingness to travel up to 30% of the time, including domestic and international travel as needed Company Description