Pharming Group N.V.

Role Description The Senior Director Labeling and Operations is responsible for directing, developing, implementing, and advising on labeling and advertising and promotional strategies for Pharming products in development as well as marketed. This individual will lead and direct regulatory labeling content through all phases of development, as well as post-approval across global markets. The incumbent will provide leadership and strategic regulatory oversight for designated projects ensuring that the latest global Health Authority requirements and standards are met. The Senior Director Labeling and Operations will also be responsible for assessment and research on regulatory precedence, to evaluate prescribing information content, advertising/promotional activities as well as educational materials. This individual will additionally be responsible to lead, develop and manage the review and approval of labeling content (i.e., TPL, CCDS, TPP). For promotional materials for marketed products, will also provide expert regulatory input, leading to the creation of strategies from an advertising and promotional perspective. Responsibilities - Leads and directs high level strategic and operational regulatory direction on projects including, but not limited to general regulatory labeling strategies, requirements, and associated risk assessments. - Demonstrated thorough understanding of product labeling content regulatory requirements in the pharmaceutical industry and healthcare environment, including policy trends globally. - Has extensive regulatory experience leading and managing the development and maintenance of product labeling, and associated review processes by managing the preparation and revision of regional labeling. - Ensures labeling content is accurate and developed in accordance with applicable Global Health Authority requirements. - Provides regulatory leadership and guidance to cross functional teams within the organization (including commercial and marketing teams) during the development, review, and approval of product labeling and advertising materials. - Prepares and submits appropriate ad/promo documentation to Health Authorities aligned with regulations. Additionally, interacts with global regulatory authorities on these submissions. - Actively participates in the resolution of key regulatory issues from the labeling and advertising and promotional perspective. - Leads regulatory oversight related to advertising and promotional activities and works directly with the marketing teams from concept through review and approval, up to and including submission. - Maintains awareness of global regulatory environment and assess impact of changes on business activities. - Responsible for the development and implementation of regulatory processes. - Uses extensive knowledge of regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues to support corporate goals. - Ensure that legal compliance is an essential aspect of all department operations. - Understand the legal and regulatory frameworks that govern operations of the department and ensure that the company has effective personnel and procedures to meet the requirements. - Know the department’s vendor relationships, scope of services provided by each vendor, and legal restrictions applicable to each. - Provide for procedure and guidance development, training, monitoring and reporting to ensure internal controls of company operations and vendor controls of vendor operations ensure adherence to legal requirements. Qualifications - Bachelor of Science degree in a life sciences or technical field from an accredited university; advanced scientific-related degree preferred. - RAC Certification preferred. - In depth knowledge of global regulatory affairs requirements for pharmaceuticals and biologics. - A minimum 15 years related experience in Global Regulatory Affairs. - At least 10 years of experience involving global labeling operations, development and maintenance. - At least 5 years of experience involving the direct implementation of promotional labeling and advertising regulations in the biotech/pharmaceutical industry globally; this must include experience providing regulatory input and evaluation as part of a promotional review committee. - Excellent oral and written communication skills are a must, as are superior planning skills. - Detailed-oriented, self‑motivated, and be comfortable with broad responsibilities in a fast-paced environment. - Ability to travel as needed both domestic and internationally (average of one trip per quarter). - Commitment and alignment to Pharming’s mission, core values and behaviors. Salary Range Pharming takes into consideration a combination of candidate’s work experience, training, and education, as well as the scope of the role, complexity, and external market and internal value when determining a salary level. The base salary range for this job is from $230,000 to $290,000 per year. Compensation & Benefits - A fully remote work schedule. - Competitive compensation package including annual target bonus. - Long-term incentive program. - 401(k) plan with company match. - Paid Time Off (PTO). - 13 Company Holidays per year. Other Benefits - Excellent benefit plans including medical, dental, and vision. - Flexible spending accounts. - Company-provided life insurance, short-term disability, and long-term disability plans. - Optional accident, hospital indemnity, critical illness, and pet insurance plans. - Tuition reimbursement program. - Health and wellness program. - Choice of company provided mobile phone or cell phone stipend. Additional Information Pharming Healthcare, Inc. is a merit-based equal opportunity employer. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected classes. An applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request via email to HR-US@pharming.com. Unsolicited resumes from agencies should not be forwarded to Pharming. Pharming will not be responsible for any fees arising from the use of resumes through this source. Pharming will only pay a fee to agencies if a formal agreement between Pharming and the agency has been established. The Human Resources/Talent Acquisition department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

Role Description The Senior Clinical Data Manager (Sr. CDM) serves as the primary in‑house data management expert within a near-to-fully outsourced clinical execution model. This role provides strategic oversight and hands‑on leadership of all data management activities across the development programs in the Pharming portfolio. The goal of this role will be to ensure timely, accurate, and compliant data delivery across the Pharming portfolio. - Building fit for purpose data capture systems - Database cleaning - Coordination of third-party data transfers to facilitate trial reporting - Ensuring end‑to‑end data quality, SDTM/ADaM traceability, and accuracy of all statistical outputs Responsibilities - Provide expert guidance on data implications for protocol design, endpoints, and operational feasibility. - Act as the primary liaison between Pharming and vendor data management and biostatistics teams. - Review and approve CRO plans, including Data Management Plans, CRF completion guidelines, edit check specifications, and data review plans. - Oversee CRO and vendor performance, ensuring adherence to timelines, data quality standards, and contractual deliverables. - Partner closely with Clinical team members, Safety and Regulatory to ensure cross-functional alignment on data strategy. - Support the development of study-specific database builds using study protocol and configuration specifications, including performance of the User Acceptance Testing (UAT). - Review SAPs and TLF mock shells for feasibility, completeness, and alignment with collected data, ensuring complete end-to-end traceability: CRF → SDTM → ADaM → TLF outputs. - Periodically conduct targeted QC of key listings (e.g., AEs, SAEs, ConMeds, labs, vitals, exposure, efficacy assessments) to identify outliers, missing data, unexpected patterns, and data inconsistencies; drive their resolution with CROs. - Manage clinical data cleaning and delivery activities, including (soft) database lock, for interim analyses, DMC/DSMB reviews, and final CSR. - Ensure all data cut and database lock criteria are met and documented. - Ensure alignment between data management findings and statistical programming outputs. - Ensure AE/SAE data quality, including reconciliation with safety narratives and coding consistency (e.g., MedDRA). - Validate treatment-emergent flags, exposure metrics, and safety population definitions produced by CRO partners. - Lead TFL review workshops and data review meetings with Medical, Safety, and Clinical Ops. - Manage ad-hoc biostatistics and data requests from Health Authorities (e.g., FDA, EMA) during NDA/BLA review and coordinate rapid turnaround analyses and data outputs with CRO Biostats/Programming. - Support data output and review for medical and scientific presentations/publications. - Collaborate with Regulatory Affairs to track requests, ensure timely responses, and document resolutions. - Drive both strategy and delivery of all data management related items. - Other duties as assigned. Qualifications - At least 6 years of clinical data management experience in the pharmaceutical/biotech industry, preferably in a small biotech. - Bachelor’s or Master’s degree in a scientific or technical discipline. - Expertise with EDC systems (e.g., Rave, Veeva, Inform) and vendor data pipelines. - Solid understanding of SAS outputs, derivations, and dataset structures (SAS programming experience a plus but not required). - Proficiency with CDISC standards, Pinnacle 21, and submission metadata tools. - Experience using AI tools to enhance work product and increase efficiency. - Proven experience overseeing outsourced DM/Biostats activities. - Experience supporting regulatory submissions (NDA/BLA) preferred. - Commitment and alignment to Pharming’s mission, core values and behaviors. Salary Range The base salary range for this job is from $130,000 to $170,000 per year. Pharming takes into consideration a combination of candidate’s work experience, training, and education, as well as the scope of the role, complexity, and external market and internal value when determining a salary level. Benefits - A fully remote work schedule - Competitive compensation package including annual target bonus - Long-term incentive program - 401(k) plan with company match - Paid Time Off (PTO) - 13 Company Holidays per year - Excellent benefit plans including medical, dental, and vision - Flexible spending accounts - Company-provided life insurance, short-term disability, and long-term disability plans - Optional accident, hospital indemnity, critical illness, and pet insurance plans - Tuition reimbursement program - Health and wellness program - Choice of company provided mobile phone or cell phone stipend

Role Description The Senior Clinical Project Manager (Sr. CPM) is responsible to plan, initiate, execute and report assigned clinical studies in accordance with the study protocol, ICH-GCP guidelines, SOP’s and other relevant laws and regulations. The Sr. CPM selects, guides, and supervises third party vendors and defines budgets, timelines, and resources for the assigned clinical studies. The person in this position implements effective training and guidance of study team interactions, study sites and external contributors throughout the course of a trial. This needs to be executed in close cooperation and transparent communication with cross-functional teams such as: Clinical study team, Pharmacovigilance, Supply Chain, Regulatory Affairs, Quality Assurance - requiring a huge ability to coordinate multiple, parallel processes in order to oversee and control a successful course. Responsibilities - Coordinate with cross-functional teams during the clinical study development phase to ensure there are appropriate internal resources, IMP and sufficient budget for the conduct of the clinical study. - Oversee project level operational aspects of the clinical study, including development and management of study timelines, budget and deliverables. - Lead the selection, contracting and budget negotiations of CROs, other third-party vendors and clinical trial sites. - Plan and implement the development of essential study documents (e.g. study protocol, SAP, ICF, etc.) and manage the review by in- and external teams. - Oversee the preparation of regulatory submissions to the IRB/EC (local/central) and national health authority(ies) for the assigned studies. - Provide direction to study team members with a support role (CPCs and CTAs). - Monitor and track project progress to proactively identify risks to study timelines and budget, mitigation strategies and mitigate risks by implementing appropriate corrective and preventive actions, escalating as necessary. - Ensure adequate oversight and management of clinical study sites by the CRO/monitors. - Oversee process and aspects of timely data cleaning, data analysis and the reporting of headline results, manage and contribute to the data review process, tables/listing/figures review and development of the CSR. - Proactively identify any issues or risks for the assigned studies and implement appropriate action and escalation of the issues. - Ensure appropriate procedures are in place for timely reporting and adequate follow-up of SAEs to PHV, and subsequently to the authorities. Other Responsibilities - Provide leadership, direction, and motivation to project team members, to promote their professional development. - Prepare updates for senior leadership on the progress of study timelines/milestones, budget and resources, and summarize associated risks and risk mitigation plans. - Provide updates and information related to assigned clinical stud(ies) to cross-functional departments, as needed (i.e. to PHV for periodic safety reports). - Participate in process improvement and quality related initiatives, such as review and/or provide input and/or write departmental SOPs, templates and forms. Qualifications - Bachelor’s degree or higher in a scientific or medical field preferred; work experience can be considered in lieu of degree. - At least five years of experience in sponsor-side Clinical Project Management roles at small-to-mid sized biotech/pharma companies. - At least two years of experience with global clinical trials. - In depth knowledge of ICH-GCP and regulatory requirements. - Ability to work across multiple time zones, including Europe. - Strong knowledge of protocol and clinical drug development processes, monitoring, clinical study planning, conduct and management. - Requires project management skills and study leadership ability. - Must have excellent interpersonal, written and verbal communication skills. - Excellent time management skills. Salary Range The base salary range for this role is from $145,000-$180,000 per year. Compensation & Benefits - A fully remote work schedule. - Competitive compensation package including annual target bonus. - Long-term incentive program. - 401(k) plan with company match. - Paid Time Off (PTO). - 13 Company Holidays per year. Other Benefits - Excellent benefit plans including medical, dental, and vision. - Flexible spending accounts. - Company-provided life insurance, short-term disability, and long-term disability plans. - Optional accident, hospital indemnity, critical illness, and pet insurance plans. - Tuition reimbursement program. - Health and wellness program. - Choice of company provided mobile phone or cell phone stipend.

Role Description The Senior Medical Director is a critical member of the Clinical Research and asset development teams for napazimone. Reporting to the Vice President- Clinical Research and working closely with the Executive Medical Director and Life Cycle Team leader for napazimone, this person will provide strategic medical and scientific leadership for development-stage products with a focus on napazimone for Primary Mitochondrial Disease. The successful candidate will lead/support global clinical research and activities for napazimone and other Pharming products. Responsibilities - Lead/support clinical development (strategy, develop protocols, study start-up, close-out, oversight, and regulatory support) for napazimone studies. - Dedicated medical and scientific role to execute the clinical strategy for the napazimone program, including: - Support the pivotal napazimone studies for mtDNA Primary Mitochondrial Disease. - Lead the napazimone pediatric study plan and clinical pharmacology studies. - Lead the napazimone program for new indications. - Work cross-functionally to define, plan, and implement studies. - Lead the sponsor oversight of medical monitoring across the napazimone programs. - Analyze and oversee data from clinical trials and produce reports, including safety data, efficacy data, completeness and trend analysis eCRF data, and oversight of protocol deviations. - Lead clinical study site engagement in the US. - Participate and provide clinical input into safety and regulatory interactions. - Participate in strategic planning as part of Medical Affairs, Marketing and Business Development teams. - Provide medical and scientific leadership and support at key scientific meetings (US and International). - Extensive interactions with academic thought leaders to optimize and develop clinical trial strategies. - Perform other duties as assigned. Qualifications - Must hold a medical license in good standing in a U.S. State or Territory. - 5+ years in clinical development including managing CROs. - Experience in product launch, regulatory filings and FDA communications highly preferred. - Strong leadership and management skills. - Strong verbal and written communication skills are essential. - Exceptional interpersonal skills and problem-solving capabilities. - Ability to work effectively across a global matrixed organization. - Travel - Include 20% travel time required for the position where travel occurs locally or internationally, if applicable. - Commitment and alignment to Pharming’s mission, core values and behaviors. Benefits - A fully remote work schedule. - Competitive compensation package including annual target bonus. - Long-term incentive program. - 401(k) plan with company match. - Paid Time Off (PTO). - 13 Company Holidays per year. - Excellent benefit plans including medical, dental, and vision. - Flexible spending accounts. - Company-provided life insurance, short-term disability, and long-term disability plans. - Optional accident, hospital indemnity, critical illness, and pet insurance plans. - Tuition reimbursement program. - Health and wellness program. - Choice of company provided mobile phone or cell phone stipend.