About Us

About the Role

As the Senior Accountant you will have a direct impact on accounting and reporting activities for a fast-growing, public biotech.

Reporting to the Director, Accounting, you will be responsible for (i) assisting with monthly and quarterly close activities such as preparation of journal entries, reconciliations, financial analyses, supporting documentation and financial statements, (ii) assisting with systems implementations, including potential new ERP, (iii) assisting with management and execution of our independent audit and Sarbanes-Oxley activities, and (iv) supporting other activities such as clinical trial accruals and collaboration arrangements. You must have experience working with public biopharma companies and/or public accounting experience to be successful in this role.

This is an exciting opportunity to assist with the continued build-out of the accounting and financial reporting processes and have a significant impact on the future success of the company. 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.

Key Responsibilities

• Complete monthly and quarterly account reconciliations to ensure accurate reporting and ledger maintenance including but not limited to cash, accounts receivable, accounts payable, general ledger, fixed assets, payroll, prepaids, and purchasing.
• Assists with the Sarbanes-Oxley activities including updating system documentation, testing controls, remediating control deficiencies and coordination efforts with the auditors.
• Assists with completion of audit requests related to the annual audit and quarterly reviews.
• Assists with the implementation of accounting systems, policies, and procedures.
• Keeps up to date on overall activities of the team, identifying problem areas and taking corrective actions.
• Prepares specialized analyses in support of all business functions.
• Potential management of future team members including but not limited to activities of mentoring, training and embodying a continuous improvement mindset.
• Assists with specific projects and initiatives unique to a fast-growing biotechnology start-up, such as system implementations, updates and business process improvements and other ad hoc projects.

Experience

• CPA or CMA license preferred.
• Bachelor’s degree (B.A.) or equivalent.
• At least 5 years of related experience and/or training with 1-2 years of biotechnology or life science industry experience required.
• Working knowledge of all aspects of accounting and financial reporting.
• Flexible, personable team-player, comfortable in a fast-paced, small company environment.
• Ability to identify errors and root causes of errors, develop workable solutions or alternatives.
• Ability to work with all levels of management.
• Strong organizational, problem-solving, and analytical skills; able to manage priorities and workflow.
• Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions. 

You will make an impact: 

The Sr. Corporate Counsel will report to the General Counsel and assist on all aspects of legal operations of the business with a primary focus on drafting, reviewing, negotiating and administering contractual documents that establish business relationships with customers, vendors, employees and partners. This position will work across the business globally partnering with all functional areas as well as external legal counsel and partners, and requires expertise to structure contracts, as well as analyze contracts to ensure compliance to company policy, government and industry specifications and other requirements. The Sr. Corporate Counsel will typically handle more complex legal matters, work with the larger clients, and be confident enough to make quick and accurate independent legal decisions.

Accelerate your skills and career within a fast-growing company while impacting the future of healthcare.  

Your day to day: 

• Overall responsibility for quickly reviewing the terms and conditions of all contracts to be the most advantageous from a legal and business perspective
• Draft, edit, standardize, and negotiate contracts, and proactively handle various transactional matters through to final signature including but not limited to NDAs, MSAs, SOWs, independent contractor agreements, vendor agreements, etc., with an emphasis on technology, SaaS, professional and biometric services
• Stay abreast of legal and regulatory developments affecting the company, its clients, and industries and synthesize the information to incorporate it into company’s transactional practices
• Contact for all functional areas and external partners to ensure all legal matters are addressed efficiently and promptly
• Work across time zones to support international colleagues and clients
• Develop, implement, and enforce contract management software for the request, prioritization, drafting, review, editing, execution, filing, reporting and compliance of contracts
• Train and educate others on various legal and compliance matters affecting the business, such as life sciences regulatory matters, AI, data privacy and security
• Make decisions within area of influence/responsibility, exercising independent judgment and viewed as an interdepartmental resource
• Research novel legal issues
• Maintenance and coordination of certain corporate records
• Assists on all other matters as needed

Take the first step towards your dream career. Here is what we are looking for in this role.  

Qualifications: 

• Juris Doctor (JD) degree
• In-house corporate law experience
• Professional experience in Technology, Software, Clinical Trial Development/Life Sciences
• Experience with AI regulations, data privacy law, employment law, intellectual property law, and corporate governance
• Ability to protect the company while keeping pace with the high speed of business
• Experience redlining and negotiating a variety contracts using the latest AI technology
• Familiarity with state, federal and international data privacy and security regulations
• Outstanding interpersonal skills and ability to communicate at all levels of organization in a high stress, fast paced environment
• Demonstrates ability to take initiative beyond direct responsibilities
• Must have excellent communication and writing skills
• Must have discretion and maintain confidentiality
• Demonstrates professional and positive demeanor and is perceived as highly competent
• Ability to complete high volume of work in a timely and thorough manner with minimal rework
• Ability to work well as part of a team and independently
• Must be well-organized, highly detail-oriented, and able to manage numerous projects, shifting priorities and conflicting demands in a fast-paced environment
• Strong time management, prioritization, project management and organizational skills
• The intellect and energy to excel in a complex and ever-changing environment
• High proficiency with computer systems and programs such as Microsoft Office, Adobe, Thomson Reuters Practical Law CoCounsel, LinkSquares contract management software, digital signature software, research tools, etc.

Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours!

eClinical is a winner of the 2025 Top Workplaces USA Award for Remote Work! We have also received numerous Top Workplaces Culture Excellence Awards celebrating our exceptional company vision, values, and work-life balance. See all the details here: https://topworkplaces.com/company/eclinical-solutions/

eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here!

We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need.

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 Director, Medical Affairs (Medical Science Liaison) is a field-based medical leader responsible for shaping and executing regional field medical strategy for Iovances developmental and marketed products through high-impact scientific exchange, generation and communication of actionable medical insights, and cross-functional partnership. This role develops and sustains relationships with regional and national external experts (e.g., key opinion leaders, investigators, and healthcare systems) and leads territory planning and prioritization to support medical objectives, including clinical trial site identification and execution, consistent with applicable laws, regulations, and company policies. The Director operates with a high degree of autonomy and accountability, provides strategic thought leadership within the field medical organization, and helps establish consistent standards, processes, and capability building across the team, including coaching and mentoring as assigned.

Essential Functions and Responsibilities

• Own and advance the regional field medical strategy within the assigned territory, ensuring impactful, fair-balanced, evidence-based scientific exchange and representing Iovance as a credible, trusted partner to the healthcare community
• Lead delivery of high-quality scientific and clinical presentations on disease state(s) and Iovance products (approved and pipeline) to internal and external audiences; ensure appropriate use of approved materials, coach others on effective scientific communication, and uphold compliance requirements
• Strategically identify, map, and profile external experts (e.g., KOLs, investigators, advocacy and healthcare system stakeholders) and develop and operationalize territory engagement plans that prioritize the highest-impact accounts and inform enterprise medical priorities
• Develop and sustain strategic relationships with healthcare professionals and clinical investigators in academic and community settings; proactively identify scientific collaboration opportunities aligned with the medical plan (e.g., publications, advisory boards, investigator-initiated research support, and clinical trials, as applicable) and partner with internal stakeholders to enable execution
• Establish and maintain a high bar for insight quality by collecting, synthesizing, and communicating actionable field medical insights using approved tools and processes; identify trends, elevate insights to internal stakeholders, and help drive insight-to-action discussions and follow-through
• Provide scientific leadership for Medical Affairs activities and scientific sessions at key congresses/meetings; develop and execute regional congress engagement plans in coordination with internal stakeholders and support post-congress medical pull-through
• Lead strong cross-functional partnerships (e.g., Medical Affairs, Clinical Science, Clinical Operations, Market Access, and Commercial) to ensure coordinated execution of the medical plan, appropriate and compliant information flow, and alignment on key priorities across the region
• Model inclusive, professional leadership behaviors and contribute to a collaborative team culture through clear communication, reliable follow-through, and constructive partnership with internal and external stakeholders
• Apply strong problem-solving, prioritization, and decision-making skills to address complex field challenges; anticipate needs of patients and the healthcare community, recommend solutions consistent with medical strategy, and appropriately escalate risks and opportunities
• Demonstrate deep scientific/clinical expertise and executive presence, with the ability to communicate complex data clearly, accurately, and compliantly to a range of audiences and to influence medical decision-making
• Provide leadership and coaching (e.g., onboarding, field shadowing, sharing best practices, peer mentoring) and contribute to field medical capability building; may serve as a people manager and/or lead for initiatives, as needed
• Operate in accordance with applicable laws, regulations, and company policies (e.g., scientific exchange, privacy, adverse event reporting) and promptly escalate questions or issues through established channels
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned.

Travel

• Ability and willingness to travel up to 60% of the time within the assigned territory, as business needs require

Required Education, Skills, and Knowledge

• 12 to 15+ years of relevant biopharmaceutical/biotechnology industry experience, including 7 to 10+ years in Medical Affairs and/or an MSL role with increasing scope, strategic leadership, and accountability
• Advanced scientific degree (MD, PhD, PharmD)
• Demonstrated capability in needs assessment, facilitation, prioritization, decision making, collaboration, planning and organizing, execution and follow-up, with strong written and verbal communication and the ability to influence senior stakeholders in a matrix environment
• Strong meeting management skills and operational capabilities, including use of metrics/KPIs, documentation, and continuous improvement to drive consistent field execution
• Demonstrated ability to influence and align stakeholders within a complex matrix environment without direct authority; comfortable engaging with senior leaders and external experts
• Ability to manage competing priorities and deliver high-quality work within timelines
• Ability to work effectively within a matrix organization to achieve desired outcomes

Preferred Education, Skills, and Knowledge

• Experience as an MSL (or relevant industry role) and experience in oncology/immuno-oncology (e.g., melanoma and/or lung cancer) and/or cellular therapy
• Familiarity with the assigned territory and relevant external experts/healthcare systems
• Understanding of regulatory requirements for field-based personnel 
• Demonstrated ability to present effective and influential oral presentations
• Proven ability to coordinate across diverse functions, ensuring comprehensive and consistent planning
• Experience managing project and/or department budgets, resourcing, and vendor partnerships, aligning investments with strategic direction and demonstrating fiscal stewardship
• Demonstrated people leadership (direct and/or indirect), including hiring, onboarding, coaching, performance development, and leading through change

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

• Ability to travel, usually within the US; field-based position with potential for significant travel
• Ability to remain in a stationary position (sitting or standing) for extended periods, as needed, with or without reasonable accommodation
• Ability to move within a home or office environment and to position and transport typical work materials and equipment, with or without reasonable accommodation
• Ability to review and analyze scientific/medical information and work on a computer for extended periods, with or without reasonable accommodation
• Ability to perform repetitive hand/wrist motions associated with computer and mobile device use, with or without reasonable accommodation
• Ability to communicate and exchange information with internal and external stakeholders, with or without reasonable accommodation

Cognitive and organizational requirements: Ability to apply sound judgment; analyze and interpret information; solve problems; maintain confidentiality and discretion; manage multiple priorities; and meet timelines, with or without reasonable accommodation

Work Environment

This job operates in a professional or remote office environment and requires operating standard office equipment and keyboards. 

#li-remote

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions. 

OVERVIEW

The Principals Biostatisticians will work closely with clients and provide high level consulting services for statistical analysis, reporting, and statistical programming specific activities which may include development of statistics section of protocol, development of statistical analysis plan, randomization schedule, conducting statistical analyses, validating programming and reporting output, and developing statistical analysis report. Principal Biostatisticians will also work on statistical programming for development of analysis datasets, and clinical tables, listings, and graphs specific to trial reporting requirements. Principal Biostatisticians will work as needed assuring that all client work has met or exceeded client expectations.

Accelerate your skills and career within a fast-growing company while impacting the future of healthcare.  

Your day to day: 

• Provide consulting of statistics activities related to clinical trials. Fulfill the responsibilities of study statistician as required
• Provide mentoring and QC of statistical programmer’s outputs; define analysis data specifications. If required, validate the statistical models used for programming
• Act as study statistician - interact with client and with clinical team including programmers, clinical data managers, clinical protocol manager, and other relevant personnel. Ensure that programmers get correct specifications and data at appropriate time
• Develop, review, and finalize the statistical analysis plan
• Validate the programming deliverables and collaborate with applicable team members to rectify any issues related to statistical reporting and analysis
• Develop randomization schedule, specifications, and guidelines
• Wherever applicable, provide input in finalization of study specific data quality control plan and ensure appropriate data analysis and reporting
• Wherever applicable, develop, validate and finalize the study specific list of table and table shells for clinical study reports and for study specific deliverables
• Ensure that all comments from the clinical team with regards to statistical report delivered for study specific deliverables are being addressed appropriately
• Analyze the data and contribute to trial progression related decisions by providing necessary input during trial specific deliverables including but not limited to blinded data reviews, and interim analyses
• Collaborate with team members for regulatory reviews, representations, and supporting data analyses including the study or compound level exploratory analyses, ad-hoc analyses, and post- hoc analyses
• Develop SAS programs to generate analysis datasets, and trial specific reporting including but not limited to tables, listings, graphs, queries, and patient profile reports
• Ensure compliance with eClinical Solutions and industry quality standards, guidelines and procedures
• Other duties as assigned

Take the first step towards your dream career. Here is what we are looking for in this role.  

Qualifications: 

• Master in Statistics or biostatistics preferred
• SAS® certification is preferred
• 10+ years in Pharmaceutical/Biotechnology industry or equivalent statistical consulting and SAS programming role preferred
• Strong experience with clinical study design development, analysis, and sample size determination
• Experience with development of randomization schedule including development of IVRS specifications, and guidelines for appropriate usage of randomization schedule
• Excellent knowledge of English and with clear, concise, and accurate communications, both written and verbal 
• Detail oriented, ability to multitask with strong prioritization, planning and organization skills
• Ability and experience of delegating tasks and leading projects. Experience of working on multiple clinical protocols at the same time
• Ability to balance conflicting priorities
• Strong knowledge of ICH guidelines and other guidelines such as GCP, and 21 CFR Part 11 from different regulatory agencies including FDA, and EMEA
• Experience in developing statistical analyses reports, and in conducting statistical analyses and reporting for various trial level deliverables including but not limited to blinded data reviews, interim analyses
• Knowledge of coding dictionaries (WHO, COSTART, ICD-9, MedDRA) and clinical reporting processes
• Knowledge of CDISC® related data models such as SDTM, and ADAM. Ability to develop ADAM model for analysis and reporting of clinical trial. Through understanding of SDTM data structures

Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours!

eClinical is a winner of the 2025 Top Workplaces USA Award for Remote Work! We have also received numerous Top Workplaces Culture Excellence Awards celebrating our exceptional company vision, values, and work-life balance. See all the details here: https://topworkplaces.com/company/eclinical-solutions/

eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here!

We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need.

Pulmovant is a Roivant-backed clinical-stage biotechnology company developing innovative therapies for patients suffering from pulmonary diseases. Pulmovant’s first program, mosliciguat is designed to provide an effective, once-daily, inhaled treatment option for patients with pulmonary hypertension (PH). Mosliciguat is a novel, potential first-in-class, sGC activator with a differentiated mechanism that may have broad applicability across the PH spectrum.

Mosliciguat has been extensively characterized across a robust Phase 1 program with 170 participants dosed to date including patients with PH in the Phase 1b ATMOS study which has produced highly compelling and clinically meaningful efficacy data, as well as a favorable safety profile. Pulmovant recently completed enrollment in the Phase 2 PHocus study evaluating mosliciguat in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD), with topline data expected in the second half of 2026. Mosliciguat is also being evaluated in the Phase 2 PHactor study in combination with inhaled treprostinil in patients with PH-ILD.

As part of the Roivant family of companies, Pulmovant leverages the power of collaboration and innovation to drive progress.

For more information, please visit https://www.pulmovant.com.

About Roivant:

Roivant specializes in developing transformative medicines at an accelerated pace through the launch of nimble biopharmaceutical and health technology entities, each meticulously tailored to address a specific medical need. Since its inception in 2014, Roivant has achieved the following critical milestones in support of its vision: built over 20 Vants; 12 consecutive positive Phase 3 trials; 8 FDA approvals; 5 successful IPOs; >$6B in capital raised; >$10B in global pharma partnerships and proceeds; and continued pipeline expansion across various modalities and therapeutic areas through in-licensing and acquisition of novel product candidates and technology platforms.  In addition to a robust clinical stage pipeline, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business.

Position: Senior Director / Head of Biometrics

Summary:

Pulmovant is seeking an accomplished biostatistician to lead the Biometrics function. This individual will own and build the Biostatistics and Statistical Programming functions, providing strategic and operational leadership across all of Pulmovant’s clinical development programs.

This is a high-impact opportunity at a pivotal moment for the company. With enrollment recently completed in the Phase 2 PHocus study of mosliciguat in PH-ILD and topline results expected in the second half of 2026, the Head of Biometrics will play a critical role in shaping the analysis, regulatory strategy, and registrational path for a potential first-in-class inhaled sGC activator. The successful candidate will partner closely with Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, and external CROs to deliver high-quality, regulatory-grade biometrics deliverables and to scale a fit-for-purpose function as the pipeline advances.

Key Duties and Responsibilities 

• Lead, build, and oversee the Biostatistics and Statistical Programming functions, establishing standards, processes, and infrastructure to support a growing pipeline.
• Serve as the senior biostatistical leader across Pulmovant’s programs, including the Phase 2 PHocus and PHactor studies of mosliciguat in PH-ILD, and future late-stage and registrational studies.
• Provide strategic statistical input into protocol design, sample size justification, statistical analysis plans (SAPs), and integrated analyses (ISS/ISE) supporting regulatory submissions.
• Review data quality, completeness, and key derivations
• Review and provide feedback and QC on TLF shells and outputs
• Ensure deliverables meet SAP specifications and quality standards
• Confirm readiness of TLR package for internal/external use
• Partner with Clinical Development, Regulatory Affairs, and Clinical Operations to define endpoints, estimands, and analysis strategies aligned with FDA, EMA, and other global health authority expectations.
• Oversee CRO biostatistics and statistical programming deliverables, ensuring quality, timeliness, and adherence to CDISC (SDTM/ADaM), FDA, and ICH E9/E9(R1) standards.
• Lead preparation of biometrics components of regulatory submissions (IND, EOP2, NDA/MAA) and represent Pulmovant in interactions with FDA and other agencies.
• Drive innovative analytical approaches, including adaptive designs, Bayesian methods, and use of historical or external controls where appropriate for a rare-disease setting.
• Build and lead a high-performing team of biostatisticians and statistical programmers; mentor staff and shape the talent strategy as Pulmovant scales.
• Support data monitoring committees (DMCs), trial steering committees, and key opinion leader engagements.
• Contribute to publications, scientific communications, and conference presentations of clinical trial results.

Education and Experience 

• PhD in Biostatistics, Statistics, or a closely related quantitative field (MS with extensive industry experience may be considered).
• 12+ years (Senior Director) or 15+ years (Vice President) of biostatistics experience in the biopharmaceutical industry, including significant time leading biostatistics across late-stage development and regulatory submissions.
• Demonstrated experience leading both Biostatistics and Statistical Programming functions, including oversight of CRO partners.
• Track record of leading biostatistical strategy through successful regulatory interactions and submissions (IND, NDA/BLA, MAA); FDA submission experience required.
• Prior experience in pulmonary, cardiovascular, rare disease, or interstitial lung disease therapeutic areas is strongly preferred; experience with PH or PH-ILD a plus.
• Experience working in a small or mid-cap biotech and operating effectively in a lean, fast-paced environment.

Essential Skills and Abilities 

• Deep expertise in statistical methodology for clinical trials, including adaptive designs, longitudinal/mixed models, survival analysis, missing data, and estimands per ICH E9(R1).
• Working knowledge of statistical programming in SAS and R; expert understanding of CDISC (SDTM, ADaM) standards and submission deliverables.
• Strong regulatory acumen and ability to translate complex statistical concepts into clear narratives for regulators, executives, and clinical partners.
• Proven leadership and people-management skills; ability to attract, develop, and retain top biometrics talent.
• Excellent written and verbal communication skills, with comfort presenting to executives, regulators, DMCs, and external KOLs.
• Strategic mindset paired with a hands-on willingness to operate at all levels in a small-company setting.
• Strong cross-functional collaboration skills with Clinical Development, Clinical Operations, Data Management, Regulatory, and Medical Affairs.
• Proficient in vendor and CRO management, with proven ability to drive quality and timelines.
• High personal integrity, scientific rigor, and unwavering commitment to patients.

Pulmovant provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

We will not accept unsolicited resumes nor outreach from agencies. Please do not send agency resumes to our website or Roivant Sciences and affiliated employees. Thanks!

Statistical Programmer Contractor

Position Summary:

The Statistical Programmer Contractor is responsible for developing, validating, and maintaining SAS programming deliverables to support clinical study analysis and reporting. This role collaborates closely with Biostatistics and other cross-functional team members to produce high-quality, compliant datasets, tables, listings, and figures while ensuring adherence to project timelines, SOPs, regulatory requirements, and CDISC standards.

Responsibilities:

• Program and validate tables, listings, figures, and derived datasets using SAS.
• Develop SDTM and ADaM datasets and supporting documentation.
• Prepare and review mapping specifications and annotated case report forms (CRFs).
• Perform quality control and validation activities for programming deliverables.
• Collaborate with study team members to identify, investigate, and resolve data and output issues.
• Review study documents and provide input to improve programming quality, efficiency, and consistency.
• Maintain complete, accurate, and audit-/inspection-ready programming documentation.
• Communicate project status, risks, issues, and timeline impacts clearly to stakeholders.

 Qualifications:

• Bachelor’s degree required; Master’s degree preferred in Statistics, Biostatistics, Mathematics, Computer Science, or a related field.
• Minimum of 10 years of relevant statistical programming experience within the pharmaceutical, biotechnology, or CRO industry.
• Phase 3 and regulatory submission experience preferred.
• Strong SAS programming skills, with experience developing SDTM, ADaM, tables, listings, and figures.
• Strong knowledge of clinical trial processes, regulatory requirements, and programming documentation.
• High attention to detail, with strong analytical, problem-solving, and communication skills.

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

In the US Cell & Gene (CGT) Marketplace, the payer is not only our Commercial and Government Health Plans, but also the Formulary Decision Makers within our Authorized Treatment Centers (ATCs) who are evaluating the financial viability of our therapies against all other Cell & Gene therapies (CGTs). Iovance is seeking Health Economic Value Access and Strategy (HEVAS) Director as a part of the US Market Access function to develop and translate economic evidence into value-based messaging and will be responsible for developing payer resources, billing & coding guides and patient support in alignment with our value proposition. This individual will understand Payer, hospital and provider clinic evaluation and financial feasibility to support the US Payer field team with pre-approval market readiness (FDAMA 114), cost of care / site of care and cost-effectiveness for our key formulary decision makers. This Market Access leader will partner cross-functionally to identify pricing strategies for our approved and pipeline therapies by understanding the US Cell and Gene Market environment needs, impact to GTN, and risk for price erosion. This is an individual contributor role with strategic leadership responsibility and no direct people management.

Essential Functions and Responsibilities

• Partner with Policy and Payer Marketing on engagement strategy with external partners and formulary decision-makers primarily in national/regional health plans, CMS, integrated delivery networks (IDNs), ATCs, Large physician groups (LPGs)
• Owns the development and execution of payer resources, reimbursement resources, end-to-end payer and channel marketing; provides resources to support the market access field team and pull through strategies
• Build and drive the US value proposition story for AMTAGVI and pipeline therapies to include but not limited to impact of complete and partial responses on PROs, productivity and future treatment costs and pharmacoeconomic impact of evolving treatment patterns
• Incorporate health economics, business analytics and competitive intelligence into the development of innovative strategies to gain, improve and defend public and private market access, specifically, pricing (and contracting) strategic planning within Market Access to create innovative proposals to meet public and private payer needs
• Directs the strategy and maintenance of formulary submission packages, total cost of care US models and other economic modeling and healthcare resource use analyses
• Support field-based cross-functional teams to provide pharmacoeconomic expertise in access engagements
• Manages operations and ensures compliance of Iovance Pricing Committee, GTN implications review and update charter and plan agendas to drive development of Committee recommendations
• Assess clinical and economic data gaps at key accounts and collaborate with internal stakeholders: Medical, Policy, Reimbursement HEOR, Payer Accounts, Marketing, Legal to provide insight into health economic value needs
• Support Market Access Account team(s) with Payer and Formulary Decision Makers at key congresses, such as PCMA, AMCP, ASTCT as needed
• Work cross functionally as a liaison with the brand teams to develop, implement, and communicate strategies and tactics to ensure alignment within the Market Access team on key cross-functional priorities
• Partnering with Commercial Strategy on Market Readiness, trial design and endpoint considerations, FDAMA and value evidence creation and Go-to-Market approach
• Assist on pipeline products and indications to generate key evidence and value proposition
• Provide strategic support and clinical-economic content expertise in innovation and partnership opportunities
• Operate at the highest level of compliance and professional standards demonstrated by embracing ethical decision-making practices and guidelines in all aspects of our organization
• Acts as the subject matter expert for all health care economic policy
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform miscellaneous duties assigned

Travel - Travel required, including overnights and some weekends (up to 20%)

Required Education, Skills, and Knowledge

• Doctorate degree (PharmD, MD, DO or PhD) preferred, or equivalent combination of advanced degree and relevant experience
• 12 + years background/experience in pharmacoeconomic, cost-effectiveness, HEOR and payer interactions
• Cell therapy, Hematology/Oncology experience preferred
• Proven ability to develop and maintain relationships with key decision-makers in the US healthcare/economics ecosystem
• Experience in assessing and analyzing clinical and HEOR data gaps to provide relevant access solutions
• Must be a strong team player and effectively interface with other internal departments including regional business units, marketing, sales, medical affairs, and clinical operations
• Excellent communication and presentational skills
• Ability to take initiative and work both independently and in a team environment multi-tasking, time management, and organizational skills with proficiency in Microsoft applications

Physical Demands and Activities Required

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

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

Senior Director, Clinical Data Management and Analytics, provides leadership to the Clinical Data Management and Analytics Department and provides influence across the Clinical Development organization. As a leader of the Clinical Data Management and Analytics organization, and part of a cross-functional team of drug development scientists focused on providing hands on skills, expertise, and tools to facilitate strategic development, operational execution, and regulatory compliance to ensure data integrity for clinical trials, in addition to integration, visualization, and exploratory analysis of complex and diverse data in support of clinical development activities and decisions. Through practical hands-on work, the Lead will define approaches, processes, algorithms, and tools that support the analytics, visualizations, and decision support needs of drug development scientists and projects. The Lead will play a key role in building the team with the necessary skills, build relationships with relevant stakeholders, and implement relevant tools and approaches. The Lead will collaborate with Biostatistics leads and other members of drug development teams to ensure connectivity of exploratory analysis work in support of development, regulatory approval, and market acceptance of products. This position includes functional management responsibilities.

Essential Functions and Responsibilities

• Define and implement the overall vision, strategy, and goals for the clinical data management department.
• Lead, manage, and develop data management teams, handling resource planning, staff training, and performance reviews.
• Ensure data integrity, quality, and compliance with regulatory requirements (e.g., FDA, ICH, GCPs) and internal company policies.
• Experience with global trials and regulatory submissions (FDA, EMA).
• Generate novel insights from data and present them via rich and intuitive visualizations.
• Builds successful partnerships and seamless interfaces within the department and the broader research and development organization. Communicates proactively and effectively across several teams with diverse subject matter expertise.
• Ensures quality of deliverables by consistently applying analysis and reporting standards, and driving compliance with regulatory requirements, corporate and departmental SOPs, and work practices.
• Drives the development and implementation of innovative strategies and technologies.
• Independently develops, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and build upon existing Iovance standards.
• Provides technical guidance to external partners concerning project and data standards, and analysis practices to ensure efficient and integrated project strategies.
• Identifies opportunities for increased efficiency and consistency within the organization and provides SME support to continuous improvement initiatives.
• Adheres to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Performs miscellaneous duties as assigned. 

Required Education, Skills, and Knowledge

• Extensive experience in clinical data management and systems, with proven leadership experience in oncology therapeutic area.
• Proficient knowledge of EDC systems (e.g., Medidata Rave), CDISC standards, and clinical trial processes.
• Drive innovation and continuous process improvement within data management by implementing new technologies and advanced systems to enhance productivity and efficiency.
• Demonstrated ability to lead, motivate, and develop teams.
• Excellent communication and interpersonal skills to effectively collaborate with diverse teams and stakeholders.
• Strong problem-solving and decision-making abilities to resolve complex issues and drive solutions.
• MS, BS/BA degree, or other suitable qualification with relevance to the field.
• 13 or more years’ direct experience in clinical data management in the biotechnology OR Pharmaceutical industry.
• Excellent verbal and written communication skills and strong interpersonal skills are required.
• Demonstrated ability to develop and lead a team of individuals with diverse experience and expertise.
• Ability to explain technically complex information for a non-technical audience.
• Strong positive attitude, thrives in a dynamic, fast paced environment with many simultaneous projects.
• Demonstrates the ability to work within budget constraints, while utilizing resources efficiently and in a fiscally responsible manner.

Preferred Education, Skills, and Knowledge

• Experience with AI applications in the data management space is highly desirable.

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 or remote office environment and requires operating standard office equipment and keyboards. 

#LI-remote

Essential Duties and Responsibilities:

Customer & Market

• Lead rigorous customer discovery using Steve Blank’s Customer Development methodology — get out of the building, run structured interviews, and change the roadmap based on evidence
• Maintain a current, structured view of the competitive landscape and translate competitive signals into roadmap decisions
• Evangelize the product vision externally — at conferences, with analysts, with strategic customers, and with the Board
• Represent Medrio’s SMB clinical trial customers as the company’s chief customer advocate at the ELT

Product Craft

• Own the product roadmap — build and defend an evidence-based vision that balances new products, existing product health, and technical debt
• Drive an AI-forward product strategy: identify where AI creates distinct, defensible SMB value and ship AI-native features to market
• Prioritize deployment speed and ease of use as primary differentiators; resist feature creep from large-customer requests that distract from the core SMB product
• Use quantitative analytics — usage data, funnel analysis, retention metrics — to inform every significant product decision
• Own product release and design processes; define how features move from concept to launch in alignment with engineering’s Definition of Done
• Lead the User-Centered Design function; coach PMs and designers to produce genuinely validated, user-centered product experiences

Stakeholder & Influence

• Build a trust-based working relationship with the VP of Engineering — align on roadmap tradeoffs, share accountability for launch outcomes
• Align Engineering, Sales, Marketing, and Customer Success around a shared product direction without direct authority over those functions
• Present product strategy to the Board of Directors and investors; handle tough questions about roadmap tradeoffs and competitive positioning
• Collaborate with Sales and Customer Success on go-to-market strategy, pricing, and customer feedback loops

People Leadership

• Lead a mixed org of PM managers, senior PMs, and principal designers simultaneously with different accountability structures and career conversations for each layer
• Build an A-player product team through structured performance management, active recruiting, and deliberate talent development
• Own the product and UX opex budget; make investment tradeoffs proactively and with data

SMB Market Focus

• Position Medrio as the fastest-to-deploy, easiest-to-use platform in the SMB clinical trial market
• Build capabilities that differentiate Medrio with SMB customers — fast build/update cycles, ease of use, rapid time to value

Customers 

• CEO and Executive Leadership Team
• Board of Directors (as needed)
• VP of Engineering and engineering leadership
• Product Management and User-Centered Design teams
• Sales, Marketing, and Customer Success
• Customers, CROs, and strategic external partners

Education and Years of Experience:

• Bachelor’s degree in a relevant field — business, computer science, design, life sciences, or equivalent (Master’s degree preferred)
• 10+ years in product management, including 5+ years in a VP-level or equivalent product leadership role
• Demonstrated experience leading a mixed org — both PM managers/directors AND senior ICs (principal PMs or designers) reporting directly
• Track record of developing product leaders and senior ICs — expanding scope, increasing responsibility, and building capability over time
• Demonstrated success launching multiple SaaS products from concept through market adoption
• Direct experience practicing structured customer discovery (Steve Blank’s methodology or equivalent)
• Proven track record of shipping AI-native or AI-enhanced product features
• Demonstrated ability to present product strategy to a board of directors or equivalent investor audience
• Experience using quantitative analytics (usage data, funnel metrics, retention) to inform product decisions
• Product budget ownership — opex planning, investment tradeoffs, vendor decisions
• Life sciences or clinical trial industry experience preferred; GxP and 21 CFR Part 11 familiarity strongly preferred

Working Conditions: Remote home office. Standard office conditions. Occasional domestic and international travel for customer visits, conferences, and analyst meetings.

Other Skills and Abilities:

• AI for cloud software development and AI-native product strategy
• Steve Blank’s Customer Development methodology
• Lead, manage and hold accountable (LMA) according to Medrio standards (scorecards, people analyzer, etc.)
• Deep knowledge of clinical trial workflows, regulations (Part 11, GxP), and the purchasing process of CROs versus sponsors
• Proficiency in product analytics tools and quantitative decision-making
• User-centered design principles and experience leading a UX function
• External evangelism — conference speaking, analyst relations, or media presence
• Ability to self-serve using JIRA and related product management systems of record

About Medrio:

At Medrio, we look for smart, capable, and conscientious people to help us expand our product capabilities, grow our business, and better serve our customers. Our employees love working for us because they get to develop, market, and sell a product that advances human health, and they enjoy many perks, including

• Great benefits: We offer medical, dental, vision, and life/LTD insurance, and we cover 100% of our employees’ health insurance premiums and 50% of dependent premiums.
• Wellness: Medrio values our staff’s well-being. To prove it, we promote an atmosphere of work/life balance, including flexible work schedules and locations.
• Weekly company-wide standup.

The Medrio team is made up of individuals with a wide array of skills and interests, but all have a passion for providing the best possible user experience for our customers. We value collaboration, ingenuity and creating a culture of excellence!

Salary Range: $240,000 - 260,000 USD

To see detailed information on the data we collect during the application process, and how Medrio complies with data privacy laws, visit our Careers page.

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:

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 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:

The Statistical Programmer Contractor is responsible for developing, validating, and maintaining SAS programming deliverables to support clinical study analysis and reporting. This role collaborates closely with Biostatistics and other cross-functional team members to produce high-quality, compliant datasets, tables, listings, and figures while ensuring adherence to project timelines, SOPs, regulatory requirements, and CDISC standards.

Responsibilities:

• Program and validate tables, listings, figures, and derived datasets using SAS.
• Develop SDTM and ADaM datasets and supporting documentation.
• Prepare and review mapping specifications and annotated case report forms (CRFs).
• Perform quality control and validation activities for programming deliverables.
• Collaborate with study team members to identify, investigate, and resolve data and output issues.
• Review study documents and provide input to improve programming quality, efficiency, and consistency.
• Maintain complete, accurate, and audit-/inspection-ready programming documentation.
• Communicate project status, risks, issues, and timeline impacts clearly to stakeholders.

 Qualifications:

• Bachelor’s degree required; Master’s degree preferred in Statistics, Biostatistics, Mathematics, Computer Science, or a related field.
• Minimum of 10 years of relevant statistical programming experience within the pharmaceutical, biotechnology, or CRO industry.
• Phase 3 and regulatory submission experience preferred.
• Strong SAS programming skills, with experience developing SDTM, ADaM, tables, listings, and figures.
• Strong knowledge of clinical trial processes, regulatory requirements, and programming documentation.
• High attention to detail, with strong analytical, problem-solving, and communication skills.

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions. 

eClinical Solutions is committed to driving innovation in clinical trials through a better approach to data management and data analytics. We use the eClinical Solutions technology platform, elluminate, throughout the data management process to accelerate timelines for our clients and automate manual processes. We believe in a more agile approach to data management using our core technology elluminate - enabling our life sciences clients to proactively manage their clinical programs and make decisions. 

You will make an impact:   

As a Senior Portfolio Lead, you will be responsible for strategic oversight for assigned customers and ensuring consistency of Data Management services across a customer’s program. You will be responsible for setting data standards, establishing process improvement and process workflows along with designing optimized clinical data flows across numerous systems and taking part in technology improvement and implementation efforts. You will manage end-to-end delivery of data management services for portfolio projects, ensuring quality deliverables on time and within budget, to customer satisfaction. 

Accelerate your skills and career within a fast-growing company while impacting the future of healthcare.  

Your day to day: 

• Manage Data Management related aspects of a customer’s program. Provide proactive consultative advice and guidance on overall data management approach and strategy 
• Responsible for strategic oversight of assigned customers 
• Serve as the customer’s Subject Matter Expert (SME) on Data Management topics and strategies 
• Collaborate with the study project team on overall data management strategy for a customer’s program of studies, assuring overall quality and efficiency 
• Work with study project team members and project managers with project level scope management as appropriate 
• Provide proactive, timely communication of customer’s program status, data trends and issue resolution with internal team and customers 
• Perform peer reviews of key Data Management study documents or other Data Management deliverables to assure quality of content and, where appropriate, consistency across a customer’s program of studies 
• Provide training of Data Management staff on customer’s processes 
• Act as an escalation path for internal teams in relation to a customer’s program challenges or issues 
• Participate in the development and implementation of new customer technologies or tools 
• Map and assess current customer processes and structures for data strategy and identify gaps and areas for improvement 
• Lead cross-functional project teams to map out data needs; advise customers on relevant data, champions data appropriateness and communicate the opportunities and challenges 
• Apply data-driven methods to make informed decisions about solutions, deliveries, and teams 
• Visionary and forward thinking with the ability to influence and effectively drive organizational change and continuous innovation 
• Ability to take risks implementing innovative solutions, accelerating value to customers 
• Ability to identify areas for process and systems innovation and implement changes that will enhance the overall effectiveness of the team 
• Ability to work in a global and highly matrixed ecosystem (internal and external) with a high degree of complexity 

Take the first step towards your dream career. Here is what we are looking for in this role.  

Qualifications: 

• Bachelor of Science degree (Master’s in Science preferred) in health-related field preferred 
• 10+ years working in the Life Sciences industry, preferably with extensive experience supporting Pharmaceutical/Biotechnology/Medical Device organizations in a consultative role with a demonstrated successful record of accomplishment of delivering quality and value to clinical teams preferred 
• Able to proactively make recommendations that optimize clinical data flow and data collection designs as well as identify leading indicators of quality issues and act upon identified clinical data trends 
• Strong knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology 
• Strong project management skills a history of successful scope management, resource management, financial management, project planning and resource allocation 
• Strong client focus with proven experience delivering solutions requiring managing complex client relationships, multiple Data Management services and delivering results that exceed customer expectations for service and operational excellence 
• Extensive experience with data review and analytics applications 
• Strong understanding of Data Management concepts with an ability to implement modern decentralized trials 
• A detail-oriented team player with strong organizational skills and the ability to multi-task, prioritize and plan within a high-energy, solutions-based environment where the customer comes first 
• Intellectual curiosity about the science of drug development and how data can best support the scientific goals of a clinical program and how to champion data throughout the clinical development process 
• Excellent writing and communication skills with proven experience presenting complex ideas clearly and concisely 

Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours!

eClinical is a winner of the 2025 Top Workplaces USA Award for Remote Work! We have also received numerous Top Workplaces Culture Excellence Awards celebrating our exceptional company vision, values, and work-life balance. See all the details here: https://topworkplaces.com/company/eclinical-solutions/

eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here!

We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need.

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions. 

eClinical Solutions is committed to driving innovation in clinical trials through a better approach to data management and data analytics. We use the eClinical Solutions technology platform, elluminate, throughout the data management process to accelerate timelines for our clients and automate manual processes. We believe in a more agile approach to data management using our core technology elluminate - enabling our life sciences clients to proactively manage their clinical programs and make decisions. 

You will make an impact: 

As a Senior Clinical Data Manager (Sr. CDM) you will independently act as a study lead and are responsible for the oversight, maintenance, and management of clinical trial database(s) for assigned projects through the full data management process life cycle. You are viewed as the CDM expert and will serve as the primary liaison between eClinical personnel and Sponsor personnel. You will create and oversee the database design specifications, validation, maintenance/data cleaning, and closeout activities of project-specific clinical trial databases. As a Senior Clinical Data Manager, you may delegate tasks/responsibilities to multiple team members in multiple projects. You will provide ongoing project oversight to ensure proper planning and timely completion of high-quality Sponsor deliverables. 

Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. 

Your day to day: 

• Primary representative for eClinical Solutions and sponsor data management interaction
• Responsible for monitoring and ensuring adherence to study timelines and deliverables 
• Accountable for the overall quality of data management activities and deliverables at the study or program level 
• Ensure efficiency and consistency for data management tasks across programs 
• Communicate with global study teams 
• Participate in client study kickoff and closeout/lessons learned meetings 
• Create materials for and present at Investigator Meetings 
• Develop content and deliver Sponsor CRA and/or site training 
• Delegate tasks, support and provide guidance to study data management team 
• Oversee and/or develop data management documents including DMPs, eCRF Completion Guidelines, CRFs, and Help Text 
• Oversee and/or Develop Internal System Testing (IST) plan for database/user roles/edit check specifications 
• Participate in Internal System Testing (IST) on the database/user roles/edit check specifications 
• Assist with preparation for implementation of a centralized data management platform for strategic data cleaning and reporting 
• Utilization of centralized data management platform including graphical patient profiles and operational analytics 
• Compile the sponsor UAT package 
• Oversee and/or perform data review as documented in the Data Management Plan and Data Validation Specifications 
• Oversee and/or perform manual review/QC checks as listed in the Data Validation Specifications exception listings and reporting tools 
• Oversee and/or perform data review for overall consistency and accuracy 
• Oversee and/or perform vendor data reconciliation (e.g., IVRS, laboratory data) with the clinical database 
• Oversee and/or perform query processing/resolution 
• Provide ongoing data management reports and metrics 
• Oversee and/or develop specifications and collaborate with programming for programming and QC of manual listings, external data reconciliation, metrics and custom reports as needed throughout the study 
• Define and develop specifications for database, programming and/or edit check changes as needed throughout the study 
• Track data management issues and ensure follow up to resolution 
• Identify data issues and/or data trends, communicate to the Clinical Data Management team and Sponsor, assist with development and implementation of action plan 
• Maintain data management study documentation 
• Perform steps pertaining to database freeze/lock and coordinate all related activities 
• Ongoing evaluation of process and participate in process improvement 
• Assist in the creation and review of SOPs, WIs, and training materials 
• Mentor junior level staff and peers on all associated tasks within a study 
• Participate in proposal defenses 
• Perform other duties as requested by management 

Take the first step towards your dream career. Here is what we are looking for in this role. 

Qualifications: 

• Bachelor’s degree in Pharmaceutical/Biotechnology or higher in health-related field preferred 
• 8+ years in Clinical Data Management experience preferred  
• Knowledge of ICH/GCP guidelines, 21 CFR Part 11, clinical trial methodology 
• Strong project management experience and project team leadership skills including work planning and work delegation 
• Experience with EDC and performing data management activities 
• Excellent verbal and written communication skills 
• Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel 
• Experience with EDC and Clinical Data Management Systems  

Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours!

eClinical is a winner of the 2025 Top Workplaces USA Award for Remote Work! We have also received numerous Top Workplaces Culture Excellence Awards celebrating our exceptional company vision, values, and work-life balance. See all the details here: https://topworkplaces.com/company/eclinical-solutions/

eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here!

We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need.

 This role requires variant interpretation experience in a clinical or equivalent setting

About the Opportunity:

Full-time, US-based remote opportunity

At Genomenon, we are at the forefront of genomics research and innovation, with a mission to accelerate genetic discoveries and improve patient care.

We are seeking a Manager, Product Quality (Variant Interpretation) to lead the scientific rigor, consistency, and scalability of our variant interpretation efforts. This is a high-impact leadership role responsible for ensuring the accuracy and defensibility of data that powers our products, supports clinical decision-making, and informs pharmaceutical research.

As our curation volume, product complexity, and client engagements continue to grow, this role will serve as the scientific authority for complex variant interpretation while building and leading a high-performing QA function. You will shape how interpretation is done at scale—driving standards, improving systems, and mentoring a team of scientists.

If you are passionate about genomics, thrive in complex scientific problem-solving, and want to influence both product and patient impact, this is an opportunity to lead from the front.

Position Responsibilities:

Variant Interpretation & Scientific Leadership

• Serve as the final scientific authority for complex or ambiguous variant interpretation cases, including conflicting clinical and functional evidence
• Apply deep expertise in ACMG/AMP guidelines to ensure accurate and defensible classifications
• Leverage clinical experience to contextualize variant interpretations and ensure clinical relevance and applicability
• Guide evaluation of functional studies and literature to support high-confidence interpretation decisions
• Support high-impact client deliverables, including clinical and pharmaceutical use cases
• Germline experience preferred

Quality Assurance & Standards Ownership

• Own QA/QC standards across all variant interpretation workflows
• Ensure consistent application of internal frameworks, nomenclature standards (HGVS), and interpretation criteria
• Oversee external data quality, including ClinVar submissions and discrepancy resolution

Team Leadership & Development

• Manage, mentor, and develop a team of QA scientists and curators
• Provide coaching on interpretation, evidence evaluation, and best practices
• Set clear performance expectations and maintain accountability for quality standards

Process Improvement & Scalability

• Design, implement, and continuously improve SOPs, QA processes, and workflows
• Identify systemic quality issues and lead solutions that scale across teams and projects
• Balance standardization with flexibility to meet diverse client and product needs

Cross-Functional Collaboration

• Partner with product, engineering, and leadership to improve tools, workflows, and data quality
• Contribute to broader data and product strategy through scientific expertise 

About You:

You are a highly experienced variant interpretation expert who combines scientific depth with leadership capability. You’re comfortable making high-stakes decisions in ambiguous situations, and you take ownership of quality, not just your work, but the work of the team.

You bring a strong QA mindset, a bias toward evidence-based decision-making, and a drive to improve systems.

Required Skills & Experience

• 5+ years of hands-on variant interpretation experience in a clinical or equivalent setting
• Advanced degree (PhD, MS in Genetics/Genomics) or Genetic Counselor (CGC)
• Deep expertise applying ACMG/AMP guidelines in complex scenarios
• Strong experience evaluating clinical and functional evidence from scientific literature
• Proficiency in HGVS nomenclature, including normalization and variant disambiguation
• Demonstrated ability to make independent, high-confidence scientific decisions

Preferred / Nice to Have

• Experience with ClinVar submissions and resolving interpretation discrepancies
• Prior people management or strong leadership experience
• Experience developing SOPs
• Exposure to a broad range of disease areas or gene classes

What You’ll Bring

• Strong scientific judgment, especially in ambiguous or conflicting evidence scenarios
• A rigorous QA mindset with exceptional attention to detail
• Ability to mentor and elevate others
• Process-oriented thinking with a focus on scalability
• Clear, structured communication of complex scientific concepts
• Ownership mentality for quality, team performance, and outcomes

Why Join Genomenon

Own Scientific Quality at Scale
Shape how variant interpretation is performed across products, clients, and public data resources.

Lead and Build
Develop a high-performing team and establish systems that scale with the organization.

Make a Real Impact
Your work directly supports clinical decisions, patient outcomes, and pharmaceutical research.

Tackle Meaningful Complexity
Work on challenging, high-impact problems at the intersection of genomics, data, and real-world application.

Interview Process

• Initial Video Screen
• Technical Video Screen
• Take Home exercise
• Team Panels (2)
• TopGrading Interview

About Us

About the Role

The Senior Medical Director, Clinical Development will be the clinical and medical strategic lead of one or more clinical trials for DNTH212.

Reporting to the SVP, Clinical Development, you will steer the preparation, review and execution of clinical study synopses and protocols, investigator brochures, and clinical study reports; review SAPs and TLF shells, guide the evaluation of emerging clinical trial data, oversee/guide the data interpretation and data mining, and ensure assigned studies are conducted according to GCPs and SOPs. You will act as a the medical monitor in close collaboration with the CRO medical and clinical monitors, ensure timely recruitment in collaboration with clinical operations, oversee/guide in conducting literature searches and reviews, meta-analyses, and publishing data. You must have experience with Rare Diseases or Rheumatology within the biotechnology or pharmaceutical industries.  

This is a unique opportunity to join a growing organization with an expanding pipeline and lead clinical strategy for auto-immune indications. 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.

Key Responsibilities

• Providing clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical program.
• Leading development of clinical sections of trial and program level regulatory documents.
• Driving execution of the program and/or clinical trial in partnership.
• Supporting the Senior Vice President, Clinical Development by providing medical input into Clinical Development Plan (CDP) and Clinical Trial Protocol (CTP) reviews and contributing to/driving development of disease clinical standards for new disease areas.
• Literature review, KOL interactions, attending scientific meetings, and presenting the clinical development plan to the relevant internal stakeholders to help shape the new indication selection process.
• Leading the protocol development for the new selected indication/s, working closely with the relevant external and internal stakeholders.
• As a medical specialist, supporting and leading interactions with external and internal partners and decision boards.
• Medical monitoring of the assigned clinical trial/s, data and safety review and working closely with the clinical operations, and external partners to oversee conduct of the assigned clinical trial/s.
• Working closely with the internal and external stakeholders as well as the clinical sites, and investigators to help ensure timely recruitment.

Experience

• MD with board certification in US, with clinical experience in Immunology or Rheumatology.
• 8+ years of previous experience in clinical research in the CRO/ biotech/ pharma setting preferred. Experience in rare diseases, neurology is highly preferred.
• Proven ability to work with cross functional teams, study vendors and clinical trial sites.
• Strong business communication skills, written and verbal, and comfortable with giving presentations internally and externally.
• Knowledge – thorough understanding of GCP/regulatory requirements.
• Proactiveness – the ability to identify challenges and risks and implement appropriate actions with some supervision.
• Motivation – highly motivated and self-starter; able to organize and perform complex tasks with minimal supervision.
• Collaboration – to coordinate activities of internal cross-functional study team as well as external vendors as applicable.
• Open-mindedness – listen to ideas from others and seek guidance when applicable; inform manager as situations arise to brainstorm and seek best solutions.

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

About Us

About the Role

The Director, Clinical Quality Assurance (QA), will be responsible for end-to-end quality oversight of global clinical trials to ensure compliance with applicable regulatory requirements and internal standards.

Reporting to the Sr. Director, Clinical QA, you will provide independent quality oversight of clinical development programs, ensuring that clinical trial conduct, data integrity, and sponsor oversight activities meet expectations of global regulatory authorities (e.g. ICH, FDA, EMA, MHRA, etc.)

You will partner cross-functionally with Clinical Operations, Clinical Development, Data Management, Pharmacovigilance, Bioanalytical, CMC, and Regulatory Affairs teams, while working closely with other functions of the Quality Unit (e.g. Clinical Quality Systems and Quality Systems and Compliance) to ensure the global GCPs are met for our clinical studies and to support inspection readiness and quality system alignment. Your role will be integral in assuring Dianthus is always inspection ready. You must possess experience and skill collaborating and influencing CRO’s, laboratories, and other clinical vendors in order to be successful in this role.

This is a unique opportunity to join a rapidly growing organization and have a significant impact at Dianthus. 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.

Key Responsibilities

• Provide proactive, risk-based quality oversight for global clinical trials across all phases (e.g. Phase I, II, and III).
• Serve as the primary QA lead for clinical development programs, ensuring quality is embedded from study design through close-out.
• Ensure compliance with ICH E6 (R3) GCP and applicable global regulations (e.g. FDA, EMA, MHRA, etc.)
• Provide expert guidance on quality risk management, issue escalation, and mitigation strategies.
• Establish and maintain robust sponsor oversight frameworks for CROs and other third-party vendors.
• Ensure effective oversight of delegated activities, including monitoring, data management, and safety management.
• Collaborate with the Quality Unit to assess vendor qualification, performance metrics, and compliance trends.
• Lead and execute a risk-based GCP audit program, including investigator site audits, clinical vendor/CRO audits, and clinical process/system audits.
• Align audit strategy with clinical milestones and BLA readiness.
• Oversee audit findings, CAPAs, and effectiveness checks, ensuring timely and sustainable resolution.
• Ensure data integrity principles (ALCOA++) are embedded across clinical programs.
• Partner with the Director/Sr. Director of Clinical Quality Systems and the Sr. Director of Quality Systems and Compliance to support inspection readiness activities, provide audit insights and risk signals, contribute to inspection strategy and preparation.
• Participate in regulatory inspections as a QA subject matter expert.
• Act as a trusted advisor to Clinical Development and Operations leadership.
• Drive a culture of quality, compliance, and continuous improvement.
• Provide QA input and conduct QC of protocols, amendments, CSRs, and regulatory submission components.
• Provide quality oversight of bioanalytical activities, including review of bioanalytical method validation documentation to ensure alignment with regulatory expectations and clinical program needs.
• Lead or contribute to quality governance forums and risk review boards.
• Identify and assess systemic quality risks and compliance gaps
• Ensure appropriate classification and management of protocol deviations, serious breaches, and inspection findings.
• Escalate critical risks to senior leadership with clear, risk-based recommendations.
• Additional duties may be identified by functional management based on current project/business objectives.
• Some travel (approx. 20%) is required for company meetings and support of audits or regulatory inspections (e.g. in support of Sr. Director Quality Compliance as needed).

Experience

• BS or MS degree in life sciences or related field required.
• 12+ years of experience in GxP with minimum of 5+ years in GCP within the biotech or pharmaceutical industry.
• Deep knowledge of GCP regulations and guidance’s (e.g. ICH, FDA, EMA, MHRA, etc.)
• Significant experience supporting global clinical trials (e.g. Phase I, II and III).
• Demonstrated experience supporting or leading submissions and regulatory inspections (e.g. BLA, PMA, BIMO).
• Deep expertise of Sponsor oversight and CRO/vendor management responsibilities.
• Deep expertise in data integrity principles and risk-based quality management.
• Demonstrated experience in clinical audit strategies including investigator site audits, audit execution, and CAPA management.
• Experience working with or managing eQMS platforms and quality processes.
• Knowledge of Clinical Quality Systems.
• Experience with project management processes / tools to support in meetings, assist with project planning, and facilitate completion of tasks.
• Proven ability to lead strategically while remaining hands-on in a fast-paced biotech environment and risk-based thinking is critical.
• Proven capability to drive alignment and influence stakeholders across global, cross-functional organizations.
• Ability to translate regulatory expectations into practice, risk-based solutions.
• Excellent communication skills with the ability to engage senior leadership and regulatory inspectors.

About Us

About the Role

We are building our Clinical team and need two Senior Clinical Trail Associates who are open to owning end-to-end processes. You will report directly to the respective Senior Director, Clinical Development Operations global leads.

As the Senior Clinical Trial Associate (Sr. CTA)/ Sr. Associate, you will play a crucial role in the Clinical Development Operations (CDO) department to support the planning, execution, and management of clinical trials in accordance with regulatory requirements and industry best practices.  In this role, you will collaborate with cross functional study teams, clinical Research Organizations (CROs), and other external vendors to ensure the successful delivery of clinical study activities.

You must have experience supporting global clinical study teams in order to be successful. Experience in rare diseases is ideal, however not required. We are looking for someone who can grow with our organization and will continue to support your ongoing development. 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.

Key Responsibilities

• Provides support to assigned clinical studies, taking on various responsibilities to support project and study deliverables.
• Coordinates, attends and may lead study team meetings; ensures appropriate meeting scheduling and documentation, including creation, distribution and filing of meeting agendas and minutes.
• Maintains and generates applicable study trackers and documents (for example: action-decision log, storyboard, patient enrollment and IRB approvals).
• Monitors clinical trial insurance and license agreements across studies and work with vendors to ensure current agreements.
• Supports the development and review of study documents, including study manuals.
• Maintains knowledge and acts as team super-user or subject matter expert for study-related systems and processes.
• Manages deliverables and navigates changing priorities.
• Supports the clinical team with coordination and preparation for investigator meetings, PI calls, conferences as well as internal clinical meetings.
• Supports management of the Trial Master File according to Sponsor Oversight plan to ensure accuracy and completeness.
• Assists with study budget oversight, including invoice tracking, reconciliation and collaboration with cross-functional teams and vendors.
• Participates in vendor selection and management meetings (e.g., CROs, IVRS, Central Labs, etc).

Experience

• BA/BS degree or equivalent, relevant work experience.
• Minimum of 5 years’ experience working on clinical studies in pharmaceutical, biotech, or CRO setting preferred. Prior CTA experience required.
• Excellent interpersonal and communication skills with ability to work collaboratively across functional teams.
• Strong organizational and time management skills, and strong attention to detail.
• Knowledge of global regulatory and compliance requirements for clinical research.
• Experience with essential documentation for Trial Master Files required.
• Knowledge of drug development, clinical operation processes, medical terminology, and procedures according to FDA GCP/ICH regulatory guidelines.
• Excellence with MS Office products Word, Excel, SharePoint, PowerPoint.
• Experience working with clinical trial systems (CTMS, IRT, EDC) preferred.
  
  

Essential Duties and Responsibilities:

• Establish and maintain operational readiness frameworks for existing products, releases, and product partners
• Define and enforce readiness criteria to ensure offerings are implementable, supportable, and scalable
• Build and standardize processes for ongoing product releases, partner enablement, and cross-functional execution
• Coordinate execution across Product, Professional Services, Sales, Marketing, Support, and Engineering to ensure alignment and accountability
• Serve as the central point of coordination for third-party partners (e.g., AG Mednet, Pharmaseal), ensuring operational alignment and scalability
• Translate product enhancements and partner initiatives into clear operational plans, including workflows, ownership, and delivery models
• Establish and maintain structured customer feedback loops, incorporating insights from internal and external Product Advisory Councils into operational planning
• Identify and resolve gaps between product design and real-world customer usage
• Define and track key metrics related to readiness, operational efficiency, and partner performance
• Provide clear communication on readiness status, risks, and dependencies to internal stakeholders and leadership
• Continuously improve processes and frameworks to reduce friction and support scale

Customers or Clients:

• Conducts market research and interviews customers in order to obtain product feedback, inform GTM strategy, and validate customer profile 
• Partners with internal stakeholders across Product, Professional Services, Sales, Marketing, Support, and Engineering.
• Collaborates with external partners (e.g., AG Mednet, Pharmaseal, ThoughtSphere) to ensure successful execution and delivery of integrated solutions.

Education and Years of Experience:

• 6+ years of relevant experience in Product Operations, Organizational Readiness, Project Management, and/or Product Management
• Bachelor’s Degree
• Clinical Trial experience preferred but not required 

Working Conditions (include any required travel): 

This position is remote, and may require some travel (~10- 25%)

Other Skills and Abilities:

• Strong ability to bring structure to ambiguous and evolving environments
• Proven experience driving cross-functional initiatives without direct authority
• Excellent organizational and operational thinking skills
• Strong stakeholder management and communication skills, including executive-level interaction
• Ability to balance strategic thinking with hands-on execution
• Experience working with third-party vendors or strategic partners preferred

About Medrio:

At Medrio, we look for smart, capable, and conscientious people to help us expand our product capabilities, grow our business, and better serve our customers. Our employees love working for us because they get to develop, market, and sell a product that advances human health, and they enjoy many perks, including

• Great benefits: We offer medical, dental, vision, and life/LTD insurance, and we cover 100% of our employees’ health insurance premiums and 50% of dependent premiums.
• Wellness: Medrio values our staff’s well-being. To prove it, we promote an atmosphere of work/life balance, including flexible work schedules and locations.
• Weekly company-wide standup.

The Medrio team is made up of individuals with a wide array of skills and interests, but all have a passion for providing the best possible user experience for our customers. We value collaboration, ingenuity and creating a culture of excellence!

Salary Range: $120,000 - 140,000 USD

To see detailed information on the data we collect during the application process, and how Medrio complies with data privacy laws, visit our Careers page.

Essential Duties and Responsibilities:

• Develop, maintain, and scale end-to-end automation frameworks for UI, API, and backend services independently with minimal supervision.
• Integrate automated tests into CI/CD pipelines to ensure fast, reliable delivery.
• Define and execute comprehensive testing strategies across API, UI, integration, regression, performance, and security testing.
• Collaborate with engineers to improve code testability, reliability, and overall product quality.
• Track and analyze quality metrics, automation coverage, defect trends, and regression risks; recommend improvements.
• Participate in code reviews and provide technical guidance from a quality perspective.
• Mentor and coach junior QA/SDET engineers, promoting best practices in automation and quality engineering.
• Drive quality initiatives across teams, influencing design and architecture decisions to enhance testability.
• Leverage AI/ML tools for intelligent test generation, prioritization, defect prediction, and test data management.
• Advocate for quality in product planning, release readiness, and post-release analysis.

What You'll Do

• Implement & Enhance: Translate requirements into robust, maintainable test automation using Python and Robot Framework. You’ll be expanding our existing suite, not just running static tests.
• Leverage AI Safely: Utilize AI tools (like Cursor) to boost your development velocity. You will be responsible for validating, debugging, and refining all AI-generated code to meet our internal standards.
• Architecture Stewardship: Build out test scenarios using the Page Object Model (POM), ensuring code reuse and long-term maintainability.
• Pipeline Management: Monitor and debug our CI/CD pipelines (Jenkins), ensuring test results are actionable and feedback loops are tight.

Tech Stack You'll Work With

• Languages: Python 3.11+
• Frameworks: Robot Framework 6.1.1, Playwright, Selenium
• Core Patterns: Page Object Model (POM)
• Tools: Cursor (AI-assisted coding), Pabot (Parallel Execution), Git, Jenkins, Testrigor, Postman
• Cloud Environments: GCP, Azure
• Database: SQL/ Oracle DB (Strong relational database knowledge)

Working Conditions (include any required travel): 

• Remote

What We're Looking For

We need a Quality Engineer who balances technical precision with a forward-thinking    mindset. You don’t just test code; you build systems that ensure long-term stability.

• Software Quality Expertise: 3–5 years of experience in software quality engineering, with deep hands-on expertise in test automation frameworks (e.g., Playwright, Selenium) and testing libraries.
• Engineering Proficiency: Strong coding skills in Python or JavaScript. You don't just write scripts; you write clean, modular, and maintainable code.
• Architectural Awareness: You understand the "why" behind patterns like Page Object Model and can implement them independently to create scalable testing suites.
• Technical Ecosystem: Solid understanding of the SDLC, Agile practices, and CI/CD pipelines. You have experience working with cloud environments (GCP or Azure), relational databases (SQL), and developer tools like GitHub Actions.
• AI-First Mindset: You’ve experimented with AI coding tools and understand their limitations. You know that while AI can generate a script in seconds, a human engineer is required to ensure it is reliable, secure, and optimized for intelligent test coverage and defect prediction.
• Security & Collaboration: You respect the "guardrails" for eg: data security and environment separation are second nature to you. You thrive in cross-functional environments, partnering with architects and stakeholders to solve complex problems.
• Mentorship: You have a passion for mentoring junior team members and fostering a culture of quality across the engineering organization. 
• Experience working in a clinical trial industry or healthcare is a huge plus

About Medrio:

At Medrio, we look for smart, capable, and conscientious people to help us expand our product capabilities, grow our business, and better serve our customers. Our employees love working for us because they get to develop, market, and sell a product that advances human health, and they enjoy many perks.

The Medrio team is made up of individuals with a wide array of skills and interests, but all have a passion for providing the best possible user experience for our customers. We value collaboration, ingenuity and creating a culture of excellence!

Salary Range: $120,000 - 140,000 USD

To see detailed information on the data we collect during the application process, and how Medrio complies with data privacy laws, visit our Careers page.

Bioinformatics Machine Learning Intern

RefinedScience | United States (hybrid or remote)

At RefinedScience, our mission is to advance care by bringing together the best science, data and minds – disease by disease, patient by patient, cell by cell to discover pathways to life beyond disease.

What We Are Looking For

We are seeking a highly motivated Bioinformatics Machine Learning Intern to join our team. This internship is designed for Ph.D. candidates with experience applying machine learning, deep learning, or generative AI methods to single-cell omics data. You will contribute to active projects spanning single-cell biology, multiomics integration, and computational approaches to precision medicine and drug development.

Our Bioinformatics team plays a crucial role in integrating computational biology, large-scale data analysis, and machine learning to drive discoveries in precision medicine and drug development.

Key Activities

• Analyze single-cell and multiomics datasets to extract biological insights supporting precision medicine and drug development programs
• Apply and evaluate machine learning and deep learning approaches to single-cell data for tasks such as cell type classification, biomarker discovery, and patient stratification
• Explore and prototype generative AI and LLM-based approaches to accelerate biological data interpretation and scientific workflows
• Collaborate with scientists, clinicians, and data scientists to design and execute data-driven research projects
• Document and optimize computational workflows following reproducible research best practices
• Present findings through technical reports, visualizations, and presentations to cross-functional teams

Must Haves

• Current Ph.D. candidate in Bioinformatics, Computational Biology, Computer Science, Biostatistics, or a related quantitative field
• Single-cell omics experience: Demonstrated ability to process, analyze, and interpret single-cell data (scRNA-seq, scATAC-seq, CITE-seq, or spatial transcriptomics) using frameworks such as Scanpy/scverse, Seurat, or Bioconductor
• Machine learning expertise: Applied experience developing and evaluating ML/deep learning models on biological data, including neural network architectures (GNNs, transformers, autoencoders), model selection and benchmarking, and integration of ML approaches into analytical workflows
• Programming proficiency: Python and/or R for data analysis, statistical modeling, and visualization
• Statistical foundation: Understanding of statistical methods for biological data (hypothesis testing, differential expression, multiple testing correction, clustering)
• Strong problem-solving skills and ability to communicate complex insights effectively

Desired Qualifications

Machine Learning & AI

• Experience with deep learning frameworks (PyTorch, TensorFlow, JAX)
• Familiarity with graph neural networks, attention mechanisms, or transformer architectures applied to biological data
• Experience with ML experiment tracking and reproducibility (MLflow, Weights & Biases)
• Exposure to representation learning, variational autoencoders, or contrastive learning methods
• Familiarity with scikit-learn, XGBoost, or similar ML libraries
• Interest in or experience with LLMs, RAG systems, or agentic AI tooling

Bioinformatics

• Experience with multimodal single-cell integration (Seurat WNN, scvi-tools/MultiVI/totalVI, Muon)
• Familiarity with spatial transcriptomics analysis (Squidpy, cell2location, nf-core/spatialvi)
• Experience with cell-cell communication inference (CellChat, NicheNet, LIANA)

• Knowledge of drug-gene interaction resources (CMap/LINCS, OpenTargets, ChEMBL)

Engineering & Infrastructure

• Familiarity with Linux/Unix CLI and version control (Git/GitHub)
• Experience with containerization (Docker, Singularity) and environment management (conda, venv)
• Exposure to cloud computing platforms (GCP preferred)
• Familiarity with workflow managers (Nextflow, Snakemake)
• Adherence to best-practices for conduct reproducible computational research

Duration

8–10 weeks

Why You'll Love RefinedScience

Team + Values

At RefinedScience, we seamlessly integrate top-tier clinical and biological data with expert knowledge to provide unparalleled insights. We maximize patient impact with these unique insights by optimizing clinical trial probability of success and time to actionable results. We work across biopharma and we are a trusted partner in achieving better results, faster – working together to unlock strategic advantage.

Our Values

• Act with Purpose – We believe in rigor through deliberate and thoughtful actions
• Be Curious – Curiosity is the spark that ignites innovation and growth
• Take Ownership – True ownership leads to pride and commitment in the work we do
• Invest in Relationships – Building strong connections is the foundation for effective collaboration and trust for long term success
• Embrace Agility – We celebrate agile thinking, resilience, and adaptability

Compensation

• $34-$38 per hour

Are you a medical professional fluent in Arabic and eager to shape the future of AI? Large-scale language models are evolving from clever chatbots into powerful engines of scientific discovery. With high-quality training data, tomorrow’s AI can democratize world-class education, keep pace with cutting-edge research, and streamline clinical work for healthcare professionals everywhere. That training data begins with you—we need your expertise to help power the next generation of AI.

We’re looking for Arabic-fluent professionals with a strong medical background—whether you’ve worked in clinical care, medical research, public health, biomedical education, or related fields. You should be comfortable engaging with topics across medicine, including internal medicine, pharmacology, pathology, clinical diagnostics, medical ethics, human physiology, epidemiology, immunology, and evidence-based medicine. You’ll challenge advanced language models on subjects like differential diagnosis, drug interactions, treatment protocols, pathophysiological mechanisms, clinical trial design, public health interventions, and diagnostic imaging interpretation—documenting every failure mode so we can strengthen model reasoning.

On a typical day, you will converse with the model on clinical scenarios and theoretical medical questions in both Arabic and English, verify factual accuracy and logical soundness, capture reproducible error traces, and suggest improvements to our prompt engineering and evaluation metrics.

A background in medicine, healthcare, or biomedical sciences is required. This could include clinical experience, academic or research work, health communications, medical translation, or public health engagement. Clear, metacognitive communication—explicitly articulating reasoning and decision processes (“showing your work”)—is essential.

Ready to turn your Arabic medical expertise into the knowledge base for tomorrow’s AI? Apply today and start teaching the model that will teach the world.

We offer a pay range of $6 to $65 per hour, with the exact rate determined after evaluating your experience, expertise, and geographic location. Final offer amounts may vary from the pay range listed above. As a contractor, you’ll supply a secure computer and high-speed internet; company-sponsored benefits such as health insurance and PTO do not apply.

Job title: Medical Specialist (Fluent in Arabic) – AI Trainer
Employment type: Contract
Workplace type: Remote
Seniority level: Open