Title: Global Study Director - FSP - EMEA - Remote, Milano, Italy - Remote, Romania - Remote, Serbia - Remote, Bulgaria - Remote, Poland - Remote, Netherlands Full time Remote Join Us as an Global Study Director - Make an Impact at the Forefront of Innovation The Global Study Director (GSD) is a business-critical role within Cell Therapy Clinical Operations (CTCO) whose main accountability is the operational planning and delivery of high priority and complex clinical studies within a program, that are deemed most critical to the business. The GSD is responsible for leading a cross-functional study team (core and extended) and for providing the team with direction and guidance to enable successful study delivery. The GSD may provide input to early study planning activities based on operational expertise. The GSD is accountable to the CPT for the delivery of a study, or studies, according to agreed upon timelines, budget and quality standards by ensuring an effective partnership and teamwork within the study team. The GSD will also interface with other internal stakeholders cross-functionally, and/or external partners, to identify, manage and resolve issues affecting study delivery. The GSD leads the study team(s) and/or study oversight team(s) in accordance with the Study Team Operating Model for Internal Delivery (SOLID), Project Management Framework and/or clinical outsourcing model, current clinical trial regulations (e.g. ICH GCP), Standard Operating Procedures (SOPs), policies and best practices and in line with our values and behaviours. The GSD is also responsible for providing expert guidance, direction, mentoring, and support to Global Study Managers on their studies, for study specific activities. What You'll Do: - Lead and coordinate a cross-functional study team of experts in accordance with SOLID and its roles, accountabilities and responsibilities framework (RACI) to ensure the clinical study progress as planned driving achievement of milestones according to timelines, budget and quality standards. - Contribute to vendor/ESP selection activities at the study level, including bid defense, and lead operational oversight at the study level in order to ensure appropriate control over the vendor identification and selection. - Collaborate with other functions to establish strategies and identify synergies aimed at increasing efficiency of global study teams (core and extended). - Lead and facilitate communication across functions and provide guidance and support to the core and extended study team members as needed and in accordance with study-specific communication plan. - For outsourced studies, be the primary sponsor point of contact for the CRO Study Manager to ensure study delivery according to agreed upon timelines, budget and quality standards, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study, in accordance with relevant SOPs and guidelines (e.g. description of services and transfer of obligations). - Provide operational expertise into and hold accountability for the development of essential study level documents (i.e. Clinical Study Protocol (CSP) through to Clinical Study Report (CSR)) in accordance with relevant SOPs. - Ensure all external service providers (i.e. central laboratories, IXRS, ePRO, etc.) engaged at the study level are performing to contracted goals and timelines/budget and that adequate oversight is documented through planning & control activities. - Develop and maintain relevant study plans (e.g. global study management plan and its relevant components such as study project plan SPP) including required input into study level quality and risk management planning (e.g. risk-based quality management, proactive risk and contingency plans, etc.), ensuring that the risk response strategies and issue escalation pathways are clear to the entire study team. - Oversee study level performance against agreed upon plans, milestones and key performance indicators (KPIs, quality and operational) by using company tracking systems and project timelines (e.g. SPP, data flow metrics dashboard, CTMS or eTMF dashboard) and communicate any risks to timelines and/or quality to CPT, along with proposed mitigations. - Providing expert guidance, direction, mentoring, and support to Global Study Managers on their studies, for study specific activities. - Identify and report quality issues that have occurred within the study in accordance with relevant SOP and collaborate with all functions as necessary to overcome barriers and achieve milestones; proactively communicate findings and corrective action plans (CAPAs) to relevant stakeholders (e.g. CPT, quality assurance staff, functional line management, etc.). - Oversee Trial Master File (TMF) completion in accordance with relevant AZ SOPs, including ensuring the TMF plan and Expected Document List (EDL) are in place and that QC activities are performed on an ongoing basis to ensure TMF completeness at all times. - Ensure timely compliance with company-wide governance controls (e.g. Delegation of Authority, Sunshine Act, financial attestations, Clinical Trial Transparency). - Responsible for study budget re-forecasting following initial budget estimate provided by the CPTand accountable for study budget management through the study lifecycle and for providing budget progress reports to the CPT including any financial risks and mitigation plans (as part of the ongoing study change control process). - Ensurestudiesareinspection-readyatalltimes,accordingtoICH-GCPandSOPandrelevant policies/guidelines. GSD is the primary CTCO Clinical Operations point-of- contact in the event of an audit or inspection. - Provideregularfeedbackonindividualperformancetothestudyteammembersandtheirline managers to support their professional development. - Provideguidance,training,expertinput,mentoringandsupportto lessexperiencedGSL colleagues on an ongoing basis. - Leads non-drug project work such as CTCO representative in process improvements and/or leading improvement projects as discussed and agreed upon with their manager Education & Experience Requirements: ·Universitydegree(orequivalent),preferablyin medical or biological sciences or discipline associated with clinical research ·Provenprojectmanagementexperienceand training ·At least 10 yearsofclinicaltrialexperience ·Atleast 5 yearsofexperienceinglobalstudy leadership and team leadership ·Demonstratedclinicaltrialexpertisein Oncology Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions. Knowledge, Skills, Abilities: • Comprehensive therapeutic area knowledge, clinical development guidelines and directives and regulatory guidelines • Expert knowledge of the key principles of cross functional project management (Time, Quality, Cost) • Excellent oral and written communication and presentation skills • Demonstrated leadership and interpersonal skills including the ability to lead, motivate and coordinate cross-functional project teams • Technical and systems competency, such as computer skills, to include effective use of systems and applications such as Microsoft Outlook, Word, Excel and PowerPoint, as well as organization systems (CTMS, Preclarus, Clarity) • Proven flexibility and ability to effectively prioritize workload and resources for project team members in a frequently changing environment • Skilled in process improvement and strategic development, especially as it applies to clinical trials, clinical development and project management • Ability to coach, mentor and lead global and/or cross-functional teams with a cultural awareness • Strong financial acumen with an in-depth of knowledge and practical application of budgeting, forecasting and resource management. Project Lead • Excellent customer service, consultation and relationship building skills • Advanced negotiation and marketing skills with ability to influence others and drive results • Excellent judgment, decision making and problem-solving skills and proven ability to apply critical and analytical strategic thinking skills to manage complex/ambiguous situations • Proactive, solutions oriented and skilled at risk identification and management. Project Oversight • Excellent customer service and relationship building skills with the ability to proactively address and prioritize expectations • Strong executive presence and business acumen • Advanced negotiation and marketing skills with ability to influence others and drive results • Proactive, solutions oriented and skilled at risk management • Excellent judgment, decision making and problem-solving skills and proven ability to apply critical and analytical strategic thinking skills to manage complex/ambiguous situations • Ability to drive corporate strategies to capture, engage and retain repeat customers People Manager • Ability to identify and address training gaps for soft skill and technical development, including managing performance stewardship, metrics and retention • Excellent judgment, decision making and problem-solving skills and proven ability to apply critical and analytical strategic thinking skills to drive development and retention of top performers • Proven ability to act as a change champion • Ability to collaborate and foster accountability in a learning environment • Ability to drive process improvement and strategic initiatives • Strong negotiation skills with ability to influence others and drive results.

At Prime Therapeutics (Prime), we are a different kind of PBM, with a purpose beyond profits and a unique ability to connect care for those we serve. Looking for a purpose-driven career? Come build the future of pharmacy with us. Job Posting Title Clinical Pharmacist- REMOTEJob Description The Clinical Staff Pharmacist is responsible for the processing and documenting of Utilization Management requests (e.g. formulary exceptions, prior authorization, step therapy, quantity limit exceptions) for delegated products and services. Responsibilities - Process the clinical evaluation for coverage determination requests for prior authorization (PA) or other utilization management (UM) programs, including quantity limits, step therapy, formulary exception and tier exception; this includes consideration of the denial language and appropriateness of the decision as it pertains to the clinical content of the case and the intent of the individual client’s pre-approved criteria - Consult directly with healthcare providers to address non-formulary and clinical product coverage issues - Collaborate with team members to ensure consistent decision-making across the pharmacist team - Respond to medication-related inquiries via phone, providing accurate information to patients, providers, and clinics regarding medications, formulary options, and coverage questions - Other duties as assigned Minimum Qualifications - Doctor of Pharmacy (PharmD) or Bachelor of Science Pharmacy Degree - 1 years of work experience in clinical, retail, hospital, or managed care - Current pharmacist license in good standing with the State Board of Pharmacy Must be eligible to work in the United States without the need for work visa or residency sponsorship Additional Qualifications - Strong verbal and written communication skills - Ability to work efficiently with computers and digital tools ​ Preferred Qualifications - Managed care experience Every employee must understand, comply with and attest to the security responsibilities and security controls unique to their job, and comply with all applicable legal, regulatory, and contractual requirements and internal policies and procedures Every employee must be able to perform the essential functions of the job and, if requested, reasonable accommodations will be made to enable employees with disabilities to perform the essential functions, absent undue hardship. In addition, Prime retains the right to change or assign other duties to this job Potential pay for this position ranges from $51.92 - $88.46 based on experience and skills. To review our Benefits, Incentives and Additional Compensation, visit our Benefits Page and click on the "Benefits at a glance" button for more detail (https://www.primetherapeutics.com/benefits). Prime Therapeutics LLC is proud to be an equal opportunity and affirmative action employer. We encourage diverse candidates to apply, and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sex (including pregnancy), national origin, disability, age, veteran status, or any other legally protected class under federal, state, or local law.   We welcome people of different backgrounds, experiences, abilities, and perspectives including qualified applicants with arrest and conviction records and any qualified applicants requiring reasonable accommodations in accordance with the law. Prime Therapeutics LLC is a Tobacco-Free Workplace employer. Positions will be posted for a minimum of five consecutive workdays.

• Foster and maintain strong, collaborative relationships with Patient Support Program (PSP) teams. • Serve as the primary point of contact for all PSP-related infusion inquiries and escalations, ensuring timely and effective responses. • Partner with Patient Support Programs to develop and optimize operational processes that support efficiency and continuity of service. • Design, implement, and maintain comprehensive training materials, documentation, tools, and procedures to support seamless collaboration between PSP teams and clinical service providers. • Establish, monitor, and report on PSP key performance indicators (KPIs) to evaluate program performance and ensure data integrity across clinical partnerships. • Collaborate with Program Managers and actively participate in pharmaceutical client meetings to align strategies and strengthen stakeholder relationships. • Ensure adherence to patient support program protocols, procedures, and compliance requirements. • Engage with PSPs and manufacturers to understand product-specific requirements for safe administration and ensure accurate and timely post-infusion reporting. • Schedule and facilitate regular touchpoints and training sessions with PSP leaders to promote continuous improvement and service excellence. • Analyze and respond to patient and caregiver feedback in a timely manner, escalating issues to the Manager, Clinical Services and Partnerships for appropriate follow-up with infusion providers. • Partner closely with scheduling teams to ensure patient and program needs are met, addressing challenges in a proactive and collaborative manner. • Maintain clear and consistent communication between programs, facilitating meetings focused on operational performance and productivity. • Collaborate with cross-functional partners to ensure cohesive and aligned operations across the organization. • Ensure vendor compliance with established program protocols, procedures, and service standards. • Partner with the Manager of Clinic Partnerships to enhance program, patient, and prescriber experiences by sharing feedback, identifying trends, and communicating operational challenges and opportunities. • Perform additional duties as assigned by management.

What if cancer drugs could find the tumor – and go nowhere else? What if this meant you could get potent therapy directly to the tumor, sparing healthy cells? That’s the future we’re building at Shasqi, using Nobel Prize-winning science to unleash powerful therapies only where they’re needed. We’re a small, driven team encompassing broad backgrounds and experiences, united by a single mission: make cancer treatments more effective with minimal side effects. Our Operating Principles - We move fast because speed matters to cancer patients. - We aim to communicate openly and challenge ideas regardless of job title. - We are bold, take risks, and push boundaries being led by science. - We operate with humble confidence: meaning we can balance our sense of capability and conviction without ego, while being humble to seek advice and learn from our mistakes. If that fires you up, come build the future of cancer therapy with us! You’re the right fit for Shasqi if you.. - Are mission driven and eager to do the best work of your career, developing novel therapies that will transform cancer treatment. - Can balance scientific rigor with a fast-paced environment. - Are comfortable with ambiguity and making decisions in the face of uncertainty. - Operate with a strong sense of agency and invite feedback and advice. - Can challenge convention and think of creative solutions that meet the needs of the company. - Are a doer, hands-on, resourceful, and do not hesitate to step up. - Willing to collaborate, debate, commit to decisions clearly, and revisit when evidence demands it. Position Summary Shasqi is hiring a Director, Clinical Operations to build and lead our clinical operations function for our oncology program. We’re looking for an individual who’s not afraid to get hands-on in the early days but is ready to spread their wings and help shape something much bigger as we grow. You will be the first hire shaping this function from the ground up, delivering high-quality, on-time, on-budget execution for a single Phase 1/2 study while designing it to scale across multiple programs. We are seeking a capable leader with the ability to deliver operational excellence and meet aggressive clinical milestones. The Director of Clinical Operations will report directly to the Chief Medical Officer (CMO). Required qualifications: - 10+ years pharma/biotech experience, with 5+ years in oncology clinical operations (must include Phase 1 and 2 studies). - Experience scaling ops from a first in class program to multiple programs in a biotech startup environment. - Proven track record building and leading clinical ops teams, including direct hiring, mentoring, and performance management - Hands-on experience leading global Phase 1/2 oncology studies end-to-end, from study startup to database lock - Strategic thinker who translates vision into actionable plans and proactively mitigates risks- knows what can go wrong and how to proactively prepare for all possible outcomes. - Strong vendor/CRO management: selection, oversight, issue resolution at executive level - Expertise in financial planning, budgeting, forecasting, and resource allocation for clinical programs - Advanced analytical skills; Excel/MS Project/Smartsheet expert for timelines, trackers, risk registers - Highly organized, detail-oriented, autonomous yet collaborative - Tech-savvy with passion for tools/processes driving efficiency - Cross-functional leadership in matrixed organizations, influencing without authority - Excellent communicator (written/verbal); comfortable presenting to C-suite/executives Responsibilities including but not limited to the following: - Lead operational delivery of Shasqi's lead oncology clinical program, ensuring on-time/on-budget execution while building scalable processes - Serve as hands-on leader: roll up sleeves for critical tasks (study startup, site management, monitoring oversight) - Build and scale clinical ops function: hire/ train first team members, establish SOPs, systems for growth - Own clinical budgeting, forecasting, resource planning; achieve fiscal targets with <4% variance - Select/manage CROs/vendors; negotiate contracts, oversee performance, resolve escalations - Drive risk management, scenario planning, contingency strategies for study milestones - Collaborate cross-functionally with others in the organization for integrated program success - Provide strategic input to clinical development strategy; represent ops on leadership team - Travel to sites as needed to meet with investigators, estimated 10% travel. How We Work: - We are a remote-first company, with occasional travel for in-person team meetings or scientific conference attendance. - Core collaboration window: 9:00am–3:00pm Pacific Time. You are expected to be available during this time for meetings and real-time collaboration. - Async + sync balance: Outside of core hours, we work asynchronously, but timely communication and follow-through are expected. - Meetings: You should be comfortable joining video calls, sharing availability on calendar and actively participating during core hours. - You should be comfortable working across common tools including Zoom, Google Workspace, Microsoft 365, Slack, and similar platforms. Benefits & Eligibility Compensation at Shasqi - Competitive base salary as part of a broader total rewards package. - Equity: Included as port of total compensations. - Comprehensive benefits: medical, dental, vision, 401(k) match, short- and long-term disability. - Flexible PTO and a WFH stipend to support remote work. - Ongoing growth opportunities, professional development, and mentorship. Salary Range - The anticipated base salary range for this role is $200-$240K USD - Final compensation will depend on location, experience, skills, education, and internal equity. - Our ranges are intentionally broad to reflect market conditions and the specialized nature of our work. Eligibility - U.S.-based employees only. - Must be authorized to work in the United States. - We are not currently sponsoring visas. About Shasqi Shasqi is a biotech company advancing a new class of targeted cancer therapies, built on Nobel prize-winning technology called click chemistry. Backed by leading biotech investors, we are building a pipeline of first-in-class therapies that are designed to overcome the limitations of ADCs increasing efficacy and limiting toxicities. Our lead asset will be entering the clinic in early 2027. You can learn more about our company at www.shasqi.com Please Note: At this time, Shasqi is not partnering with external recruiting agencies. We kindly ask that agencies refrain from contacting us regarding this role. Shasqi is an Equal Opportunity Employer. We are committed to creating a diverse and inclusive workplace and do not discriminate on the basis of any protected characteristic under applicable law.