Job Purpose:

Provide integrated support to patients and physicians by providing a hands-on approach to improve the quality of patient care. This is accomplished by developing personalized relationships with patients and prescribers of assigned clinics to improve medication adherence and promote evidence-based care expanding into various disease states therapy management.

Job Duties:

The Ambulatory Clinical Pharmacist (ACP) will help advance quality pharmacotherapy care by actively assuring the provision of safe, efficacious, and cost-effective drug therapy. The ACP collaborates closely with the hybrid ACP team to maximize full suite of therapy management (TM) clinical services within supported clinics. The pharmacist performs in-person and/or virtual/phone assessments on disease state management and drug therapy education stratified based on medication risk level and approved clinic protocol. ACP role will focus to identify, resolve, and prevent medication-related problems. Additional services will also be offered to overcome identified barriers to medication compliance and any other obstacle related to adherence.

SUMMARY:

• Provide medication management for individuals, including medication reconciliation, dose modification and/or optimization, ordering laboratory tests and medication adherence counseling within the stated parameters of the approved protocol/CPA/CDTM.
• Collaborate with the interdisciplinary care team to develop individualized care plans that align with evidence-based guidelines and best practices for therapy management.
• Monitor and evaluate medication regimens to ensure clinical criteria are met, including therapeutic goals, adverse effects, and drug interactions.
• Identify opportunities for drug therapy optimization and provide recommendations for medication cost savings initiatives when applicable.
• Participate in quality improvement initiatives by actively participating in clinical outcome studies, REMs compliance/reporting, and ACP-related process improvement projects.
• Optimize resources and workflows with supporting roles handling complex prior authorizations/appeals by providing clinical justification for medication approval, including supporting literature and rationale.
• Collaborate with healthcare providers, including assigned clinic physicians, specialists, and onsite clinic pharmacists, to ensure seamless medication management and coordination of care.
• Support occasional peer-to-peer requests upon demand.
• Perform clinical assessments/educational counseling at drug-level for all patients within high priority clinics on qualified on a targeted medication(s).
• Ensure all clinical criteria is in clinical compliance with guidance from FDA, clinical guidelines, and appropriate evidence-based literature.
• Assist with workflow optimization initiatives, including identifying areas for improvement and implementing strategies to enhance efficiency, productivity, and quality of care.
• Collaborate with other departments and stakeholders to identify operational changes and recommend strategies that enhance productivity, quality, and standards of excellence.
• Advocate for and promote patient safety and medication literacy through patient education and counseling.
• Protects organization's value by keeping information confidential.
• Updates job knowledge by participating in educational opportunities; professional publications; maintaining personal networks; participating in professional organizations to promote new line of services.
• Attend and participate in team meetings, conferences, and other professional development activities to stay abreast of current clinical practices and emerging trends.
• Stay updated with the latest advancements in therapy management and incorporate them into clinical practice.
• Willing to do whatever is necessary for the betterment of the Company.
• Other duties as assigned by Senior Director of Clinical Services and Manager of Clinical Services.

Experience/ Education:

Required Licensure/Certification:

• Applicant must hold a Doctor of Pharmacy degree (PharmD) from an accredited school of pharmacy
• Must be a licensed pharmacist in CO.
• And meet any one of the following:
  
  • Possess certification in a relevant field of practice
  • Completed a postgraduate residency through an accredited postgraduate institution where at least 50% of the experience included the provision of direct patient care services with interdisciplinary teams
  • Have provided clinical services to patients for at least one year under a collaborative practice agreement or protocol with a physician, advanced practice pharmacist, pharmacist practicing collaborative drug therapy management, hospital pharmacy practice or health system

Additional Training/Competency:

• Applicant must complete the required continuing education requirements to maintain CO state Pharmacist license if selected for position

Skills: Ability to analyze information, exercise good judgment, possess strong verbal communication skills, have deep knowledge of pharmacology developments and FDA health regulations. Ability to manage processes, exhibit strong technical and clinical skills, maintain constant focus on legal compliance, while being highly productive with a focus on quality and
details. Strong clinical knowledge and validated expertise with focus on disease state. management and treatment guidelines.

Traits: Organized, high-integrity, attention to detail, dependable, quality focus, empathetic, good listener/communicator.

Other: Energetic, highly motivated, team player with strong personal and communication skills; discretion and confidentiality essential as position deals with highly sensitive and private data.

Salary:

An employee in this position can expect a salary rate between $127,000-$133,000 plus bonus pursuant to the terms of any bonus plan if applicable. The actual salary will depend on experience, seniority, geographic location, and other factors permitted by law.

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

Overview

The Lifecycle leader (LCL) is responsible for shaping the program vision, strategic context, and lifecycle plan (LCP) across indications globally. The LCL oversees the development and execution of the LCP in line with the company strategy.  They are able to navigate complex program challenges, the commercial and development landscape and assess and prioritize development in future indications.

Essential Functions and Responsibilities

• The LCL is responsible for shaping the program's cross-functional vision, strategic context, and lifecycle plan (LCP) for both current and future business opportunities.
• The LCL, in partnership with the Program Manager, will work with leadership & SMEs (subject matter experts) to build out appropriate internal ways of working to enable best practices around development of data driven recommendations, decision making and communication.
• As the single point of accountability in a cross-functional team, the LCL ensures timely delivery and manages the associated execution plan and milestones, closely aligning them with the approved LCP.
• The LCL oversees integration across Iovance involving multiple stakeholders to ensure optimal program execution in line with program strategy and LCP.
• Collaborating with functional team leaders, the LCL fosters alignment across the different sub -teams to ensure execution will achieve team and corporate goals (Commercial Team, Development Team, Regulatory Team etc.)
• Serving as a point of triage, the LCL facilitates clear decision-making by incorporating cross-functional input to address high-impact issues. This involves co-creating solutions to complex challenges in real time.
• The LCL leads the team in framing program needs and develops a range of options and recommendations for presentation to the Executive Leadership Team (ELT). The LCL ensures transparent communication with senior leadership, highlighting relevant scenarios, assumptions, and risks to inform decision-making and trade-offs. The LCL also represents the enterprise mindset and ensures all relevant functional perspectives have been considered.
• The LCL ensures the inclusion of subject matter experts (SMEs) and situational members in discussions, guided by a predefined agenda set with guidance from the Program Manager.
• The LCL is accountable to the ELT for program recommendations and frames them within the context of the broader portfolio.
• The LCL is accountable for day-to-day management of the program to ensure all established deliverables with high program impact remain on track and in line with program strategy.
• The LCL is responsible for ensuring the health of the team, creating a highly functional environment with collaborative ways of working where debate and honest feedback are encouraged
• Other responsibilities to consider: Risk identification and mitigation planning; ensuring financial stewardship of approved and recommended projects; clear communication throughout organization of key milestones, deliverables and progress; ensure appropriate resourcing of functions to achieve program goals and vision.

Additional Responsibilities:

• May work with Development and Commercial Teams to define the disease area strategy and to execute a business plan with clear deliverables and resource needs. This includes defining priorities and an approach to leveraging external opportunities in close collaboration with Business Development and academic experts.
• Advocates on behalf of Iovance and effectively communicates scientific/medical/clinical concepts in both written and oral communication to both internal and external stakeholders.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned. 

Required Education, Skills, and Knowledge

• Bachelor's degree in a scientific discipline; advanced or professional degree highly desirable (e.g., PhD, MD, or MBA).
• 15+ years of bio-pharmaceutical industry experience with at least 5 years of relevant work experiences in the biotech/pharmaceutical industry as a Lifecycle Leader or Program Team Leader.
• Must demonstrate strong knowledge of the overall drug development process relevant to biotech/ pharmaceutical companies; commercial launch experience and a depth of experience with drug development is required.
• Experience working with or on program strategy teams required.

Preferred Education, Skills, and Knowledge 

• Strong leadership skills from leading cross-functional teams in a matrix organization, with highly collaborative instincts and a track record of resolving conflicts within the team.
• Ability to communicate clearly and effectively with clinical scientists, biologists, manufacturing experts, as well as with regulatory and commercial colleagues at all levels of the organization.
• High degree of organizational awareness and understanding of change management and leading innovation.
• Possess significant depth and breadth of experience across phases of drug development that enable you to immediately bring considerable strategic value to a project.
• Possess understanding of drug development experience and understand what it takes to shepherd an asset through its lifecycle.

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

Physical Demands and Activities Required

• Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
• Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
• Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
• This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
• Must be able to communicate with others to exchange information. 

Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines. 

Work Environment 

This job operates in a professional workplace or remote office environment and requires standard office equipment and keyboards. Employees who work remotely are expected to maintain their workspace and environment safely and free from safety hazards.

#LI-remote

About Us

About the Role

As the Associate Director, Pharmacovigilance, you will work closely with the Safety team to support ongoing clinical trials.

This role is critical in ensuring patient safety and regulatory compliance throughout the drug development lifecycle. Day to day, you will work closely with safety physicians, clinical teams, and external stakeholders to manage safety data and contribute to safety oversight. You must have experience reviewing adverse events, safety signals, and coordinate/contribute to the Safety Review Committee (SRC) and Drug Safety Monitoring Boards (DSMB) meetings. You must have experience supporting clinical pharmacovigilance activities and working with DSMBs in order to be successful in this role.

This is a unique role that will allow you to work collaboratively with the growing pharmacovigilance team that is working closely with cross functional teams to help Dianthus elevate the care of our patients' lives. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients' lives. We are open to you working remotely within the United States.

Key Responsibilities

Safety Data Review

• Oversee pharmacovigilance activities for assigned clinical programs, ensuring alignment with global regulatory requirements and internal SOPs.
• Review, evaluate, and provide managerial oversight of adverse event (AE) reports, including serious adverse events (SAEs), ensuring accurate assessment and timely submission to regulatory authorities and ethics committees.
• Ensure quality and accuracy of safety data review within the safety database and direct reconciliation efforts with clinical databases to maintain data integrity.

Cross-functional Communication & Collaboration

• Contribute to the development of safety sections within clinical documents, including protocols, investigator brochures, and clinical study reports.
• Manage and oversee the scheduling, planning, and facilitation of DSMB and SRC meetings, including preparation of agendas, meeting materials, guided discussions, documentation of minutes, and follow-up on action items.
• Contribute strategically to the preparation of aggregate safety reports such as the DSUR.
• Partner with safety physicians on signal detection, emerging safety issues, risk assessments, and benefit–risk evaluations.
• Serve as a subject matter expert to internal stakeholders and external partners on safety-related topics, providing guidance and ensuring consistent communication.

Documentation & Compliance

• Ensure organizational compliance with global pharmacovigilance regulations (FDA, EMA, ICH) and company policies.
• Manage and oversee pharmacovigilance-related quality events, including change controls, deviations, and CAPAs, ensuring timely resolution and documentation.
• Supervise and ensure accurate documentation of DSMB and SRC meetings and maintain records within designated systems and repositories.

Experience

• Education: PharmD or RN degree required.
• Experience in pharmacovigilance or in clinical development within biotech or pharmaceutical industry.
• Proven experience reviewing adverse events and working closely with safety physicians.
• Hands-on experience supporting DSMBs and SRCs and preparing safety deliverables.
• Proficiency in Microsoft Office Suite and Microsoft Teams, with the ability to leverage these tools for efficient communication, scheduling, and documentation
• Strong knowledge of global PV regulations (FDA, EMA, ICH guidelines).
• Excellent analytical, organizational, and communication skills.
• Ability to thrive in a fast-paced, start-up environment and manage multiple priorities.
• Fluency with Argus safety database
• Familiarity with rare disease or oncology programs.
• Prior experience in a start-up or small biotech setting.

Position Summary:

The Senior Manager, Quality Assurance, Drug Product focus, will report to the Director, Quality Assurance. The Senior Manager is responsible for collaborating with cross-functional teams and external partners to ensure both clinical and commercial Drug Products and Devices meet regulatory requirements and internal Vera standards.

Responsibilities:

• Responsible for quality oversight of biologics sterile drug product (DP) manufacturing and combination products, including design control and Design History File (DHF) requirements.
• Responsible for implementing strategies and tactics to promote and maintain GxP compliance.
• Lead quality aspects of and provide quality support on DP tech transfers.
• Liaise with CMO Quality partners to communicate QA policy and procedures.
• Collaborate with contract manufacturers and internal stakeholders to address deviations/ investigations and compliance issues.
• Responsible for material disposition of commercial and clinical DP/ combination products.
• Review executed batch records and associated documentation for material disposition.
• Review and approve GMP documentation such as master batch records, deviations, change controls, specifications, and various other protocol and reports to support GMP production.
• Review and approve validation protocols and reports such as process validation, shipping validation, cleaning validation, etc.
• Provides assistance during both internal and regulatory agency audits as required
  Perform Person-in-Plant duties, as required.
• Participate in Material Review Board as required.
• Helps define and implement appropriate quality standards/specification, methods, systems, and metrics for clinical and commercial quality operations.
• Act as the Quality representative on assigned product teams to advocate compliance and quality assurance.
• Lead for Quality Agreement with external partners.
• Support product lifecycle and continued process verification.
• Availability for 10-20% travel, both domestically and internationally.

Qualifications:

• Bachelor’s degree in biomedical engineering, chemical engineering, pharmaceutical sciences, or a related field. Advanced degree preferred.
• Minimum 10+ years of experience in a GMP Quality, Compliance, and/or Regulatory setting.
• Minimum 6+ years in a GMP QA role, with a preference for direct experience in biologics sterile DP manufacturing/aseptic processing including vials and prefilled syringes/autoinjectors.
• Excellent written and verbal communication skills, including a demonstrated ability to effectively communicate in a project team environment, within department, among functional groups and among external collaborators.
• Innovative skills with problem solving and peer influence.
• In-depth knowledge of FDA, ISO, EMA, GMP and ICH quality systems and regulatory requirements.
• Experience of working with external partners.
• Strong attention to detail is a must.
• Excellent interpersonal, written and oral communication skills.
• Outstanding organizational skills.
• Ability to operate in a fast-paced, multi-disciplinary industrial environment.
• Capable and comfortable with normally receiving no instructions on routine work and general instructions on new assignments.
• Familiar with global medical device/combination products standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, and EU MDR is a plus.

The TMF Manager will report to the Executive Director, Clinical Quality Assurance and will support the quality and integrity of the Trial Master File (TMF) and electronic Trial Master File (eTMF) across clinical programs. This role helps ensure clinical trial documentation is complete, accurate, and maintained in accordance with regulatory requirements and industry standards throughout the clinical trial lifecycle.

The Clinical Quality Assurance organization partners with Clinical Development and cross-functional stakeholders to promote and maintain high-quality clinical research practices across the drug development lifecycle. The function provides independent oversight to ensure clinical trials are conducted in compliance with global regulatory requirements and that the organization maintains continuous inspection readiness.

This role provides oversight of Trial Master File management to ensure clinical trial documentation is organized, complete, and maintained in a state of continuous inspection readiness for our Vera studies. The individual partners with study teams, functional document owners, and system users to monitor TMF health, identify documentation gaps, and support effective TMF management throughout the lifecycle of clinical studies.

The position also serves as the eTMF system administrator and collaborates with Clinical Quality Assurance leadership to support system governance, implement improvements through appropriate change control processes, and provide training and guidance to study teams and functional stakeholders.

The role operates with a high degree of independence in monitoring TMF quality and completeness while working closely with cross-functional teams to ensure documentation practices align with regulatory expectations and organizational procedures.

Responsibilities:

• Provide oversight of Trial Master File management across clinical development programs and functions. The position partners closely with Clinical Operations, Clinical Supply Chain, Data Management, Pharmacovigilance, Regulatory Affairs, and other development functions to ensure essential clinical documentation is appropriately maintained within the TMF. Partner with study teams, functional document owners, and system users to facilitate periodic TMF health discussions and ensure alignment on TMF quality and completeness expectations.
• Interface with CROs and external vendors responsible for TMF activities and contributes to maintaining TMF inspection readiness across the organization. In addition, the position supports TMF lifecycle activities including study start-up planning, ongoing TMF maintenance, study closeout, and TMF archival in accordance with regulatory and company retention requirements.
• Contribute to establishing and maintaining consistent TMF management practices across studies and programs to support alignment with regulatory expectations and industry best practices.
• Conduct routine TMF health reviews and collaborate with study teams and document content owners to identify documentation gaps and ensure appropriate remediation.
• Oversee quality, completeness, and timeliness of Trial Master File (TMF/eTMF) documentation across clinical studies, ensuring appropriate governance of TMF practices across study teams and functional document owners.
• Develop and track eTMF metrics for studies and communicate trends or issues identified to study teams and management
• Serve as the eTMF system administrator, supporting user access management, system configuration support, troubleshooting, and ongoing optimization of system functionality to support TMF quality and inspection readiness.
• Support regulatory inspections and internal audits involving TMF records and management, including providing eTMF navigation and demonstration of TMF document structure and audit trail traceability.
• Collaborate with the Head of Clinical Quality Assurance and system users to identify opportunities to improve TMF processes, system functionality, and inspection readiness practices.
• Work with the eTMF system owner and IT or system support teams to implement system improvements in accordance with required change control and validation procedures.

 Qualifications:

• Bachelor’s degree plus 8 Years experience in life sciences, pharmacy, or related scientific discipline or commensurate work experience managing TMFs.
• Pharmaceutical, biotechnology, or CRO experience with direct involvement in Trial Master File management desired.
• Strong knowledge of regulatory requirements and industry expectations related to clinical trial documentation and Trial Master File management.
• Trial Master File (TMF) oversight and electronic TMF systems.
• Clinical trial documentation requirements and the TMF Reference Model.
• TMF health review and document completeness monitoring.
• Regulatory inspection readiness and inspection support.
• Cross-functional collaboration with clinical development functions.
• Working knowledge of global Good Clinical Practice (GCP) requirements and regulatory expectations for clinical trial documentation.
• Experience contributing to:
  • TMF process improvement initiatives
  • eTMF system administration or system governance
  • TMF metrics development and monitoring
  • TMF closeout and archival processes
• Experience working with CROs or vendors responsible for TMF activities.

Position Summary:

The Associate Director, Clinical Quality Assurance, will report to the Executive Director, Quality Assurance. The Associate Director, Clinical Quality Assurance serves as a key quality partner to clinical study teams and provides quality oversight of clinical development activities. This role contributes to strengthening a maturing Quality Management System (QMS) by identifying quality risks, supporting risk-based decision making, and ensuring quality practices are effectively implemented across clinical programs.

The Clinical Quality Assurance organization partners with Clinical Development and cross-functional stakeholders to promote and maintain high-quality clinical research practices across the drug development lifecycle. The function provides quality oversight to ensure clinical trials are conducted in compliance with global regulatory requirements and that the organization maintains continuous inspection readiness.

This role provides proactive Clinical Quality Assurance oversight for clinical studies and development functions. The individual partners closely with Clinical Operations, Pharmacovigilance, Data Management, Regulatory Affairs, and other development function and  serves as a key member of study teams, helping identify quality issues and risks,  and reviews quality events, investigations, and CAPAs; analyzing quality signals across studies and vendors that support risk-based decision making, and ensuring quality management practices are appropriately implemented throughout the clinical trial lifecycle.

The role operates with a high degree of independence in evaluating quality risks and compliance considerations while collaborating closely with cross-functional teams to support effective implementation of quality practices across clinical development programs.

The position contributes to strengthening the organization’s maturing Quality Management System (QMS) by supporting procedural governance, audit program oversight, and quality process improvement initiatives.

Responsibilities:

• Serve as the Clinical Quality Assurance representative on assigned clinical study teams, providing proactive guidance to ensure clinical trial conduct aligns with GCP and regulatory expectations.
• Provide oversight of clinical quality events, investigations, and CAPAs, ensuring appropriate root cause analysis, corrective actions, and identification of systemic quality trends.
• Analyze quality signals across studies, vendors, and operational processes to identify emerging risks and recommend mitigation strategies.
• Contribute to governance of the clinical audit program, including risk-based selection of audits and oversight of Audit CAPA follow-up. Execution of audits is performed by the audit function.
• Serve as a quality interface with CROs and vendor quality representatives to ensure appropriate management and resolution of quality issues.
• Support inspection readiness activities and provide first-line Clinical QA support during sponsor regulatory inspections, including preparation and follow-up actions.
• Review and provide input on new or revised SOPs and controlled documents to ensure alignment with regulatory requirements and consistency across organizational procedures.
• Provide input on training assignments and training matrices to ensure procedures are appropriately implemented across functional roles.
• Participate in process improvement initiatives that support the development and strengthening of the Quality Management System, including the evaluation, assessment, and implementation of quality governance, processes, and systems.

Qualifications:

• Bachelor’s degree in life sciences, pharmacy, or related scientific discipline required. Advanced degree preferred.
• Approximately 8+ years of industry experience, including leadership in clinical quality oversight or quality governance.
• Strong applied knowledge of global GxP regulations applicable to clinical development, including:
  • Good Clinical Practice (GCP)
  • Good Pharmacovigilance Practice (GVP)
  • Good Laboratory Practice (GLP)
  • GMP experience is not required for this role
• Experience with the following is desired:
  • Quality management and oversight of clinical trials
  • Quality event and CAPA management
  • Regulatory inspection readiness and inspection support
  • Risk-based quality management approaches
  • Planning of clinical audits (including sites, internal audits)
  • Developing metrics and reviewing issues for quality signals and trends
  • SOP governance through controlled document reviews
  • Training matrix or training governance activities
• Relevant certifications such as RQAP, CQA, CCRC, or RAC are considered a plus.

Position Summary:

Reporting to the Executive Director, Statistical Programming, the Associate Director, Statistical Programming will be responsible for supporting Clinical Development programs by performing Statistical Programming tasks as well as building and computing the analytical programming environment.

Responsibilities:

• Oversee and work directly with CROs to provide guidance, effectively monitor and QC their deliveries for quality, time and budget adherence.
• Follow CDISC SDTM and ADaM standards and guidelines; validate SDTM, ADaM datasets and TFLs generated by the CRO.
• Work with the internal teams and CRO to prepare submission-readiness datasets (e.g. SDTMs, ADaMs) and metadata to support the BLA filing.
• Hands-on statistical programming to support CSR, publications, presentations, DSUR, IB update, safety data review, RTQ, and ad hoc analyses.
• Attend SMT and collaborate with the study statistician and other study team members in project planning and timeline discussions.
• Review key study documents including but not limited to study protocol, SAP, and CDM documents like CRF and DTA and provide inputs to represent statistical programming function.
• Work collaboratively with stakeholders and other developmental functions to standardize, maintain, and implement the data transformation and statistical analysis requirements.
• Ensure that all programming and data are conducted in compliance with GCP, relevant SOPs, and regulatory requirements; review and file study documentation in the trial master file (TMF) system acceptable for audit.
• Familiar with SAS server working environment and adherent to server and programming SOP.
• Proficiency in R for statistical analysis, data analysis, modeling, and data visualization

Qualifications:

• BS (10+ years) or MS (8+ years) in Statistics, Life Sciences, Computer Science or related fields and statistical programming experience in the pharmaceutical industry.
• Experience with immunological diseases is preferred.
• Excellent project and vendor management skills, directly managing CROs/vendors is preferred.
• Experience with BLA or NDA/sNDA with FDA (EMA is a plus).
• Strong SAS programming and Statistical background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat; hands on experience with R and JMP is a plus.
• Extensive experience managing CROs for clinical and statistical programming activities
• Broad knowledge of medical/biological terminology in relevant therapeutic areas, good knowledge of drug development regulations for statistical analysis.
• Thorough understanding of clinical trial design and reporting process, as well as regulatory reporting requirements including electronic data submissions and CDISC implementation.
• Great communication skills, with the ability to effectively develop and deliver strategically, while aligning and gaining the collaboration of cross-functional groups.
• Able to effectively lead functional and cross-functional projects of varying scope and complexity while prioritizing resource needs
• Strong hands-on programming skills to deliver results in a quick turnaround environment.

Position Summary:

The Senior Director, Risk Management, Drug Safety & Pharmacovigilance (DSPV) will report to the Vice President, Drug Safety & Pharmacovigilance and will be responsible for our Risk Management strategy and Benefit Risk Office at Vera which strives for excellence and the creation of a best practice framework. As a Risk Management Lead, you will be empowered to work cross-functionally with colleagues to establish and manage the processes for Risk Management, benefit risk, RMPs, additional Risk Minimization Measures and REMS programs and other Benefit Risk deliverables. The overall goal of the Risk Management Lead is to optimize the proactive impact made by the PV department at Vera while maximizing patient safety and minimizing/preventing patient risk.

Responsibilities:

• Serves as Project manager of the PV Risk Management System to oversee, evaluate, characterize, strategize, implement, assess and track vera’s PV Risk Management obligations, commitments and proposed minimization measures to ensure patient safety is at the forefront of DSPV.
• Provide recommendations and guidance through subject matter expertise on risk management and risk minimization strategy to an assigned therapeutic area to ensure that product risk management strategies are consistent worldwide.
• Provide recommendations and guidance through subject matter expertise on the structured benefit risk assessment framework and the development of the benefit risk assessment documentation.
• Work closely with cross-functional teams (e.g. Clinical Development, Clinical Operations, Medical Affairs, Regulatory Affairs, and Biostats) to ensure alignment of Vera’s global position for the PV risk management processes.
• Provide strategic expertise to cross-functional product team members in developing pharmacovigilance risk strategies including benchmarking and scenario planning.
• Support the development of risk management plans (RMPs) in modular format, review RMPs) and ensure alignment with Good Pharmacovigilance Practices and other applicable regulations.
• Remain up to date and well informed on all Regulatory intelligence as it relates to risk management and relay this to the Project team and the PV medical safety science team.
• Aide in the development and review risk minimization documents such as Developmental RMPs, RMPs, risk minimization measures and Risk Evaluation and Mitigation Strategy (REMS).
• Provide subject matter expertise and thoughtful contributions to qualitative and quantitative structured benefit risk assessments.
• Provide guidance on incorporation of the patient’s perspective into benefit-risk activities (e.g. Real-World Evidence studies with Medical Affairs).
• Collaborate with PV Physician Leads, Clinical Leads, PV scientists and Clinical Research Scientists, and others cross-functional teams on benefit risk assessment strategy.
• Develop and provide recommendations for appropriate risk management interventions such as direct healthcare professional communications, educational materials, controlled access program.
• Provide guidance and drive the creation of tracking risk management commitments including utilization of a tracking spread sheet or platform and improvement assessments
• Monitor and report risk management metrics to ensure compliance.
• Provide centralized support, training, and leadership for safety and cross-functional members who work on risk management plans and risk minimization activities.
• Support inspections and audit activities internally and externally with regards to risk management processes.
• Perform other duties as defined in standard operation procedures or requested by supervisor.
• Work with PV Physician and PV Scientists to aide in the proper characterization and classification of Risk from initial signal to evaluation, validation, implementation in study documents, protocols, IBs, ICFs, and RMPs.
• Work with VP of DSPV, PV Physicians and PV Scientists on any Regulatory Submission/filing for BLA, SBLA, MAA, etc. to be sure that risks are reflected properly and carried through to support filing activities.
• Oversee risk components of Aggregate reports like DSUR, PBRER etc.
• Work with PV Physicians and PV Scientist in risk presentations at safety Governance meetings (MSRB & MSRC) to ensure proper communication of risk is achieved and proper course of action is followed.
• Manage and oversee any outsourced RMP related activities to external vendors.

Qualifications:

• PhD/Pharmacist/ PharmD/DO/MD with 12+ years of experience.
• Minimum 5-10 years in PV/safety OR clinical development preferred.
• Minimum 5-10 years of pharmaceutical industry/drug development experience.
• Pharmaceutical industry experience, with exposure to PV risk management, additional risk minimization measures, and/or REMS programs preferred.
• Strong track record of scientific and analytical thinking.
• Experience presenting at meetings is desirable.
• Work with integrity and work proactively in a fast-moving environment.
• Good Critical thinking skills. Ability to use good analytical/judgment skills to understand, analyze, and communicate.
• Project Management Skills with ability to manage both time and priority constraints and to manage multiple priorities simultaneously.
• Attention to detail, computer literacy, knowledge of safety databases.
• Good working knowledge of all the functions within PV from PV operations onto medical safety science and all processes in between.

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

Overview

The Sr. Manager, Protein Sciences (Downstream) is an experienced manufacturing and processing subject matter expert responsible for managing Iovance’s GMP manufacturing operations and contracted manufacturing operations centered on protein production and characterization, with a focus on downstream process, including drug product formulation, fill, and lyophilization. S/He will actively collaborate with Process Development, Analytical Development,  Manufacturing, Quality Control, Quality, Supply Chain, and Regulatory functions, with a focus on ex-US manufacturing operations.

This position will report to the head of Protein Sciences, and involves planning, coordinating, and overseeing contract manufacturing and development services for Iovance products through the product life cycle. Oversight includes process development, transfer, scaleup, validation, improvements (COGS), and studies supporting technical changes/improvements. This position will also provide necessary leadership to support CMC product teams and/or lead subteams, manage technical information/data flows, manage project milestones, support audits, and assist in qualification, validation, and regulatory filing activities. Additionally, this position will be responsible for manufacturing data management for selected clinical/commercial products.  

Responsibilities

• Subject matter expert in protein purification, drug product formulation, fill, and lyophilization.
• Manage and/or support knowledge management (including product, process, and analytical)
• Manage and/or support process, analytical, microbial control strategy development and implementation, and risk assessment and mitigation.
• Build and support long term business relationships with key Contract Manufacturing Organizations in support of flexible and efficient supply chains.
• Manage and/or support technical transfer and technical/COGS improvement projects. Ensure effective stakeholder engagement and ensure on-time and in-budget delivery.
• Support regulatory CMC and registrational activities for clinical/commercial products as required, with a focus on ex-US.
• Liaise with Quality/Supply Chain on product disposition and ensure continuous alignment with quality/supply chain systems requirements. Support technical investigations, deviations and CAPAs as required. Support and participate in site audits, as required.
• Manage and/or support hiring and development of staff, as required.
• Ensure CMO site operational readiness for manufacturing campaigns/process transfer/change controls/validations; including facilities, equipment, documentation, training.
• Utilize strong operational excellence / lean principles, business acumen, quality-mindedness, and excellent communication skills to develop streamlined, efficient, and robust systems.

Required Experience

• A minimum of 9 years of related experience with a Bachelor's degree; or 7 years and a Master's degree; or a PhD with 4 years experience in a relevant Life Science discipline or equivalent in work experience.
• In-depth understanding of protein purification, characterization, drug product formulation, fill and lyophilization. Good understanding of protein expression, cell culture processing, and QC methods is a plus.
• Strong prior operational experience preferably in a direct role in a GMP manufacturing environment, with interfaces to Supply Chain, Quality and Regulatory functions, with commensurate experience supporting internationally licensed products.
• Direct experience managing contract development/manufacturing organizations (CDMOs), with focus on aseptic operations and commercial manufacturing, is preferred.
• Must possess a thorough understanding of biotherapeutics manufacturing.
• Demonstrated business and commercial focus with awareness of customer/patient-centric issues.
• Experience working in a global business environment across multiple time zones.
• Self-starter, possessing strong verbal and written communication skills.
• Ability/willingness to travel globally for extended periods, based on business needs.

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

Physical Demands and Activities Required

• Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
• Must be able to work on a tablet or computer for 80% of a typical working day.
• Must be able to move and lift 15 pounds.
• Wear proper personal protective equipment when in the warehouse, laboratory setting, i.e., safety glasses, lab coats, and closed-toed shoes.

Mental

• Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion.
• Ability to handle work-related stress.
• Ability to handle multiple priorities simultaneously.
• Ability to meet deadlines.

Work Environment

• This position will work in both an office and a manufacturing setting.
• Potential exposure to noise, equipment hazards and strong odors.

#LI-onsite

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

Overview

The Senior Clinical Trial Manager (CTM) in the Research Alliances team will independently lead and is accountable for the planning, execution, management, and reporting of clinical projects supporting Iovance commercial activities, including Expanded Access Programs (intermediate EAP, single-patient and Ex-US Access Programs) and Phase 4 post marketing studies.  In addition, the Sr. CTM/CTM will provide operational leadership for studies within a growing portfolio of Investigator Sponsored collaborations and other non-clinical collaborative research initiatives involving lifileucel and Proleukin. This position works very closely with external vendors, HCPs, as well as multiple Iovance teams: Commercial, Medical Affairs, Regulatory, Safety, Clinical, Biometrics, Quality, Legal, Quality, Supply Chain & Logistics and Manufacturing. 

The ideal candidate will have clinical operations experience within the pharma/biotech arena, be self-motivated, and able demonstrate the ability to manage complex programs independently while collaborating effectively in a dynamic, agile, and evolving organization.

Essential Functions and Responsibilities

• Oversee the timely activation, execution, and management of Expanded Access Programs (EAPs) that support commercial launch activities at authorized treatment centers 
• Leads the activities for the timely activation, execution, and management of Post Marketing study
• Oversee the timely activation, execution, and management of ISTs/non-clinical research projects
• Ensure Sunshine Act reporting data for lifileucel and Proleukin products across Research Alliances programs are collected
• Works closely with Legal to initiate CDAs, clinical trial and service agreements, amendments and change orders for EAPs, Phase 4, Investigator-Sponsored and non-clinical collaborations.
• Manages external contract research organizations involved with EAPs and Phase 4 who will have responsibility for site interaction, site monitoring, patient schedule management, data collection/management, central IRB interaction, and clinical site contracts.
• Oversee drug supplies, co-therapies, and lab supplies for clinical and non-clinical collaboration studies and EAPs.
• Reports to Iovance teams on study status, activity and site/vendor performance. Develops and maintains dashboards and trackers to communicate progress and risks.
• Ensure that Investigative sites submit monthly enrollment logs, safety listings, database transfers and quarterly reports or as required in the study agreements.
• Responsible for the writing and updating workflows, manuals, consent forms, and technical documents to support EAPs, Phase 4, ISTs/collaborations and non-clinical studies.
• Organizes and documents decisions of routine meetings with internal teams, CROs and Investigator/research teams.
• Collect and maintain essential regulatory documents.
• Contribute and lead process improvements by updating or developing SOPs and Work Instructions.  
• Performs additional job-related duties as required to support successful program execution.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform other miscellaneous duties as assigned. 

Travel - 15% of the time.

Required Education, Skills, and Knowledge

• Bachelor’s degree in health or science-related area with 7+ (Sr. CTM) or 5+ (CTM) years of clinical operations experience in the pharmaceutical or biotech area. Or an equivalent combination of education and relevant experience
• Demonstrated ability to independently initiate and manage Expanded Access Programs and Phase 1–4 clinical trials
• Proven track record of building and maintaining effective relationships with investigative sites and site personnel
• Excellent written and verbal communication skills, with the ability to collaborate across internal and external stakeholders
• Demonstrated ability to work independently, adapt to changing priorities, and manage multiple programs in a dynamic, result-driven environment
• Knowledge of US and Global Regulations and Guidance (ICH-GCP, FDA-CFR)
• Experience in data collection, review and monitoring Phase 1-4 clinical studies
• Demonstrated experience leading phase 1-4 clinical trials and supporting ISTs.
• Demonstrated success in managing clinical studies within timeline and budget.
• Strong interpersonal communication (verbal and written) with the ability to build strong relationships with peers and partners within and across functional teams to engage in high performance.
• In-depth knowledge of Microsoft Office, including MS Word, MS Excel, MS PowerPoint, and MS Outlook
• Previous experience with EDC systems (eClinical, Medidata RAVE, InForm), and electronic Trial Master File systems
• Requires working knowledge of Good Clinical Practices, Food and Drug Administration regulatory reporting requirements, and the regulations and laws governing the pharmaceutical industry (e.g., compliance, Sunshine Act)

Preferred Education, Skills, and Knowledge 

• Oncology/immunotherapy experience
• Phase 4, Expanded Access Program experience

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodation may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request accommodation.

The physical demands described here represent those an employee may encounter while performing the essential functions of this job. Reasonable accommodation may be provided to enable individuals to perform these functions.

• Ability to remain in a stationary position for extended periods
• Ability to move about within an office or remote workspace and exert up to 10 pounds of force occasionally
• Visual acuity sufficient for preparing and analyzing data, viewing computer screens, and extensive reading
• Repetitive motion involving wrists, hands, and/or fingers
• Ability to communicate effectively to exchange information
• Cognitive: Ability to engage in analytical, conceptual, and problem‑solving activities in a dynamic business environment 

Work Environment

This role operates in a professional office or remote work environment and requires routine use of standard office equipment and technology. Employees working remotely are expected to maintain a safe workspace free from recognized hazards.

#LI-remote

Overview:

Springboard is launching an online course for aspiring Pharmacy Technicians who have no prior experience in healthcare or pharmacy. Springboard is looking to hire an engaging Live Course Instructor with prior experience teaching aspiring CPhTs to supplement the self-directed and 1:1 tutoring components of the program. 

Responsibilities:

• Facilitate large-group “review sessions” (20-75 students per session) aligned to key curriculum areas over a 25-week period. Sessions will be 60 mins each. We’re expecting ~10 distinct lectures needed over this period, repeated 2-3 times each to accommodate time zones. 
• Review sessions will have a specific focus on memorization, study strategies, and recall practice – eg: sharing mnemonic devices and memory tricks to learn specific topics, and quizzing students via games. 
• Lead engaging, motivational sessions that help build student confidence on material. 
• Prepare independently for live sessions (up to 4 additional hours per week).
• Work with Springboard to develop and modify session agendas and lecture decks as needed.
• Develop gamified approaches using tools like Kahoot and others. 
• Offer 2-3 live session slots for a given topic, to accommodate different time zones. 
• Perform skill demonstrations live, as needed, for 6 key lab skills. 
• Support NHA ExCPT and PTCB exam prep by holding exam review sessions towards the end of the course. 
• Respond to student questions and help moderate the course online community channel throughout the duration of the course, specifically responding to questions about the course material. 
• This might also include monitoring Canvas discussion boards for weekly student responses and questions.
• Armed with an understanding of best practices and approaches to delivering Pharmacy Technician–aligned education online, apply your subject matter expertise in:
• Core pharmacy workflows and entry-level technician skill development
• Pharmacy law, regulatory compliance, and medication safety principles
• Pharmacology fundamentals, drug classifications, and brand/generic identification
• Dosage calculations, conversions, and accuracy protocols
• Customer service and patient-centered communication in pharmacy settings
• Appropriate depth of content for entry-level Pharmacy Technician training
• Pharmacy Technician scope of practice across retail and clinical environments
• How to recreate pharmacy workflow and skill-based training outside of a live pharmacy setting
• Determining “need-to-know” vs. “nice-to-know” knowledge for ExCPT-aligned training
• You may be called upon to: 
• Work with Springboard's Learning Experience team and Instructional Designers to adjust session content as needed. 
• Other needs as they arise 

Qualifications:

• At least 5 years of experience working as a PharmD or a CPhT. 
• Active PharmD or CPhT license and/or certification. 

Experience teaching CPhTs online. 

• Experience using online teaching tools (eg: Canvas, Zoom, Kahoot). 
• Strong presentation and facilitation skills with large student audiences; students should feel more confident and motivated leaving the session than when they arrived. 
• A robust toolkit of “memory and learning tricks” you use to teach CPhTs topics like Basic Pharmacology, Drug Classifications & Disease States, A&P, Pharm Law, Math, and more. 
• Strong student empathy, excellent communication skills and a positive outlook on the PharmTech role & Pharmacy career. 
• You live and work in the US.

Pay: Up to $40 an hour pending location and experience