ERGOMED

Operations

• Lead and oversee all operational aspects of global pharmacovigilance activities, ensuring compliance with regulatory requirements, company SOPs, and industry standards
• Manage PV teams, optimize operational processes, and collaborate cross-functionally to ensure the highest level of patient safety and product quality
• Optimize cost, speed and quality of delivery through leveraging metrics to inform management interventions
• Provide strategic direction for PV operations, aligning with corporate goals and regulatory expectations
• Develop and implement strategic plans for expansion of Safety and Pharmacovigilance services in terms of revenue, operational margins and resources
• Lead, mentor and develop PV operational teams; define KPIs and monitor team performance
• Partner with Enterprise PMO/BPO to realize objectives of the value creation plan and optimize/standardize end-to-end PV processes
• Drive operational excellence through process mapping, automation, and technology adoption including AI-supported case processing
• Lead inspection readiness and quality excellence initiatives and foster cross-functional collaboration to integrate safety insights into product lifecycle management

Executive Vice President, PV Operations

• Lead and oversee all operational aspects of global pharmacovigilance activities, ensuring compliance with regulatory requirements, company SOPs, and industry standards
• Manage PV teams, optimize operational processes, and collaborate cross-functionally to ensure patient safety and product quality
• Optimize cost, speed and quality of delivery through leveraging metrics to inform management interventions
• Provide strategic direction for PV operations, aligning with corporate goals and regulatory expectations
• Develop and implement strategic plans for expansion of Safety and Pharmacovigilance services in revenue, operational margins and resources
• Lead, mentor, and develop PV operational teams, fostering a culture of accountability and high performance
• Partner with Enterprise PMO/BPO to realize the objectives of the value creation plan (VCP)
• Represent PV operations at senior/executive management meetings and governance boards
• Define KPIs and monitor team performance
• Champion operational excellence and continuous improvement across global PV operations
• Optimize and standardize end-to-end pharmacovigilance processes, leveraging automation and emerging technologies
• Drive global harmonization of PV processes and lead inspection readiness and quality excellence initiatives
• Lead process improvement, technology adoption, change management and implementation of AI-supported solutions
• Act as strategic bridge between PV Operations and internal stakeholders, embedding safety intelligence into product lifecycle management

• Lead and oversee all operational aspects of global pharmacovigilance activities ensuring compliance with regulatory requirements, company SOPs, and industry standards
• Manage PV teams, mentor staff and foster a culture of accountability, high performance, and continuous learning
• Develop and implement strategic operational plans for expansion of safety and pharmacovigilance services (revenue, margins, resources)
• Partner with Enterprise PMO/BPO to realize value creation plan objectives and standardize end-to-end PV processes
• Define KPIs, monitor team performance, and leverage metrics to inform management interventions
• Optimize operational frameworks via process mapping, automation, AI-supported case processing and technology adoption
• Drive global harmonization of PV processes across regions, affiliates, and partners and ensure inspection readiness and quality excellence
• Collaborate cross-functionally with Regulatory Affairs, Quality, Medical Affairs, and Clinical Development to integrate safety insights into product lifecycle management
• Accurately forecast resource needs, allocate resources, and engage commercial leadership on process variation and revenue opportunities
• Lead change management initiatives and implement process improvements to enhance efficiency, accuracy, reporting timeliness, and signal detection performance

• Lead and oversee all operational aspects of global pharmacovigilance activities, ensuring compliance with regulatory requirements, company SOPs, and industry standards
• Manage PV teams, optimize operational processes, and collaborate cross-functionally to ensure patient safety and product quality
• Provide strategic direction for PV operations and develop comprehensive operational strategies
• Develop and implement strategic plans for expansion of Safety and Pharmacovigilance services in terms of revenue, operational margins and resources
• Lead, mentor, and develop PV operational teams and define KPIs and monitor team performance
• Champion operational excellence, standardize end-to-end pharmacovigilance processes, and optimize workflows through automation and technology
• Drive process improvement, AI-supported case processing, and change management initiatives
• Represent PV operations at senior/executive management meetings, governance boards, and cross-functional leadership forums
• Lead inspection readiness and quality excellence initiatives and foster cross-functional collaboration with Regulatory Affairs, Quality, Medical Affairs, and Clinical Development

• Lead and oversee all operational aspects of global pharmacovigilance activities, ensuring compliance with regulatory requirements, company SOPs, and industry standards
• Manage PV teams, optimize operational processes, and collaborate cross-functionally to ensure the highest level of patient safety and product quality
• Optimize cost, speed and quality of delivery through leveraging metrics to inform management interventions
• Provide strategic direction for PV operations, aligning with corporate goals and regulatory expectations
• Develop comprehensive operational strategies and implement strategic plans for expansion of Safety and Pharmacovigilance services
• Lead, mentor, and develop PV operational teams and represent PV at senior/executive management meetings
• Define KPIs and monitor team performance
• Drive operational excellence, standardize processes, and implement automation and AI-supported tools
• Lead inspection readiness and quality excellence initiatives
• Foster cross-functional collaboration with Regulatory Affairs, Quality, Medical Affairs, and Clinical Development
• Drive process improvement, change management, and partner with Enterprise PMO/BPO on value creation plan (VCP)

• Lead and oversee all operational aspects of global pharmacovigilance activities, ensuring compliance with regulatory requirements, company SOPs, and industry standards
• Manage PV teams, optimize operational processes, and collaborate cross-functionally to ensure patient safety and product quality
• Optimize cost, speed and quality of delivery through leveraging metrics to inform management interventions
• Provide strategic direction for PV operations, aligning with corporate goals and regulatory expectations
• Develop comprehensive operational strategies and implement strategic plans for expansion of Safety and Pharmacovigilance services in terms of revenue, operational margins and resources
• Lead, mentor, and develop PV operational teams and represent PV operations at senior/executive management meetings and governance boards
• Define KPIs and monitor team performance and collaborate with Enterprise PMO/BPO to standardize end-to-end pharmacovigilance process
• Drive global harmonization of PV processes, lead inspection readiness and quality excellence initiatives, and foster cross-functional collaboration with Regulatory Affairs, Quality, Medical Affairs, and Clinical Development
• Drive operational excellence through process mapping, automation, and technology adoption, and lead change management initiatives to adapt PV operations

Marketing

• Shape and execute the company’s global marketing strategy to position Ergomed as a trusted leader in clinical research, pharmacovigilance and life sciences solutions
• Report directly to the CCO and track/report key marketing metrics and attribution to sales pipeline
• Oversee brand, communications, portfolio marketing, client engagement, and demand generation functions
• Define messaging pillars and corporate narratives and ensure regulatory compliance across marketing activities
• Build go-to-market strategies for services across clinical, safety and pharmacovigilance and establish KPIs for initiatives
• Partner with business development to design campaigns that generate qualified opportunities and deepen client relationships
• Drive thought leadership via publications, conferences and scientific forums and manage media/influencer relations
• Lead and develop a high-performing, globally distributed marketing team and promote cross-functional collaboration with BD and Operations
• Monitor competitor marketing and CRO/PV activities and translate industry insights into strategies that increase market presence

Senior Vice President, Marketing

Clinical Operations

• Ensure that projects are delivered on time, within budget, and agreed scope, maintaining appropriate industry, sponsor and Ergomed quality standards
• Liaise with project team members, provide training where needed and ensure correct allocation to tasks
• Develop, review and edit project plans to assure consistency with goals and milestones
• Organize and facilitate project meetings related to study activities (study organization, initiation, execution, closure)
• Serve as primary point of contact with sponsor and Ergomed Senior Management on project status
• Represent Ergomed at external meetings, liaise with scientific/medical experts and committees (e.g. EC/IRB)
• Develop, review and edit relevant SOPs and develop study related training programs
• Contribute to bid defense activities

Clinical Project Manager – Oncology and Radiopharmaceuticals

Compliance

• Act as primary local contact person with local regulatory authorities for Regulatory Affairs and Pharmacovigilance
• Prompt and effective communication with local regulatory authorities
• Provision of local regulatory intelligence screening and expert advice
• Collection and reporting of locally suspected ADRs or ICSRs (follow-ups, translations)
• Local management/oversight of risk minimization measures related to urgent safety restrictions and emerging safety issues
• Preparation and collection of documentation for submissions to the regulatory authorities
• Review and linguistic input on local Product Information and mock-ups
• Development and implementation of local pharmacovigilance system in compliance with Global MAH's system and local regulations
• Perform local non-indexed literature screening and screening of regulatory authority websites for potential ADRs and safety information
• Maintain accurate records and documentation at local level
• Provide support to the RA & PV Global operations team
• Ensure compliance with MAH's and PrimeVigilance's procedures
• Support audits and inspections
• Handle local QA tasks such as suspected falsified products, quality alerts and other quality-related requirements from the local market

Local Contact Person, Pharmacovigilance and Regulatory Affairs

• The Senior Vice President, Global Marketing is responsible for shaping and executing the company’s global marketing strategy to position us as a trusted leader in clinical research, pharmacovigilance, and life sciences solutions. Reporting directly to the CCO, this role oversees brand, communications, portfolio marketing, client engagement, and demand generation functions. The Senior Vice President of Global Marketing will work closely with the Senior Management team and Functional Heads, collaborating to cultivate strong, long-term relationships with the key decision-makers in life sciences organisations. The ability to incorporate scientific, operational, and technological rigor so as to differentiate Ergomed’s service solutions is crucial.
• Key Responsibilities
• Strategic Leadership
• Develop and execute a global marketing and client engagement strategy that differentiates Ergomed Group in CRO and PV markets. Define key messaging pillars and narratives to effectively communicate the company's value proposition, competitive differentiation, and corporate story Track and report to senior leadership on key metrics and performance indicators such as attribution relative to vital sales pipeline Translate industry insights and client needs into strategies that increase market presence and pipeline quality. Monitor and track competitor marketing trend CRO/PV activities and support activities aiming to develop and retain clients Brand & Reputation Strengthen the company’s brand as a trusted, science-driven partner. Drive thought leadership through publications, conferences, and scientific forums. Ensure compliance with regulatory standards across all marketing activities. Build and maintain relationships with media outlets, industry influencers, and key stakeholders to secure positive coverage and thought leadership opportunities Portfolio, Client, & Demand Generation Marketing Build go-to-market strategies for services and solutions across clinical, safety, and pharmacovigilance. Establish key performance indicators (KPIs) to measure the effectiveness of marketing initiatives and campaigns Partner with business development to design campaigns that generate qualified opportunities and deepen client relationships. Oversee demand generation programs leveraging digital, content, and targeted outreach. Leadership & Team Development Lead a high-performing, globally distributed marketing team Set current and long-term goals for global marketing team, identify talent within, and oversee their performance Drive collaboration between Marketing and Internal Communication teams, BD and Operations. Build talent and promote a culture of accountability, innovation, and scientific credibility.

Director

• The Director / Senior Director, Operational Strategy (DOS) is a highly visible role in Ergomed, supporting the company’s objectives for winning new business through the development of comprehensive and innovative execution strategies for opportunities in the assigned portfolio in rare diseases.
• The DOS is a significantly experienced clinical research professional responsible for developing and articulating the Win Strategy in the pre-award period for new business opportunities presented to Ergomed within rare disease therapeutic areas.
• This role will require the DOS to have deep operational knowledge including experience with the development of clinical trial budgets, targeted therapeutic area knowledge, excellent interpersonal skills, and the ability to innovate.
• Upon award of a clinical trial or program, the DOS will support the ongoing relationship with the client and overall operational excellence by serving as a resource to assist in the transition of operational strategy to operational execution as needed.
• When relevant, the DOS will serve as the Executive Sponsor of the opportunity or client relationship as part of a client governance structure, in conjunction with the business development director and project management leadership.
• The DOS requires extensive clinical trial operations and execution experience to support operational design solutions, budget reviews, project oversight and information gathering.
• Role and Responsibilities
• Responsible to coordinate and develop competitive and flexible Win Strategies for potential awards, leveraging expertise, operational capabilities, and technologies to ensure client needs are addressed in the pre-award activities.
• This responsibility also includes reviewing project budgets to confirm that they reflect the agreed Win Strategy and supporting the Executive Bid Review process as necessary.
• Co-leads bid defense preparations with Business Development and participate in other client meetings as needed in collaboration with Business Development and other Senior Operational staff.
• Develops strong relations with clients’ key decision makers by leveraging knowledge and expertise to drive repeat business.
• Collaborates closely with other global functions, such as Project Management, Clinical Operations, Data Management, Statistics, Regulatory and Safety as per the scope of the opportunity.
• Supports functional teams to enhance client relations and ensure high customer satisfaction.
• Provides therapeutic and technical expertise as part of study transition and thereafter as requested or as part of governance.
• Remains current regarding the regulatory environment as it impacts the DOS’ portfolio.
• Stays abreast of the development of new, competitive, operational methodologies research in the therapeutic area or portfolio and provide training to operational leadership and business development, when appropriate.
• In the capacity of as a stakeholder in the project governance process, provide proactive guidance and direction to assigned staff around project planning, project execution, project review, risk mitigation, problem solving and customer management to assist in service delivery and professional development.
• Support business development and marketing activities by participating in conferences and meetings and generating marketing content such as webinars and white papers as part of Ergomed Group’s overall marketing strategy.
• Participate in recruitment and induction of new staff with Human Resources as requested.
• Participate actively in executive Project Review Meetings if requested and support strategy success by being available to the execution team to support any changes in strategy that may be necessary as the scope of the study evolves.
• Identify and escalate issues as appropriate within the organization.
• Support QA and functional teams in developing/adapting SOPs and working practices for SSPC functions as requested.

Director / Senior Director, Operational Strategy (Rare Disease)

Manager

• Due to the continued growth of our Global Study Start Up Group, we are now seeking a (Senior) Site Contracts Manager who will be responsible for overseeing the negotiation process of clinical study agreements on assigned trials, and who will act as a subject matter expert to our sponsors and stakeholders.
• The Senior Site Contracts Manager will be responsible for (but not limited to) the following activities: Oversees negotiations of clinical study agreements (CTAs) on a study level and drives CTA document finalization and execution, including contractual language & terms, financial attachments, and investigator budgets.
• Provides oversight of contact & budget negotiations status and manages escalation of out-of-parameter queries on budgetary and contractual requests to sponsor decision-makers.
• Plan the Clinical Site Agreement (CSA) execution strategy for assigned studies in line with overall study start-up delivery plans and client expectations.
• Work closely with internal and external stakeholders to prepare the necessary Clinical Site Agreement templates, payment terms, as well as fallback positions and negotiation parameters in line with Ergomed’s standards.
• Lead CSA negotiations on a study level and drive the finalization and execution of CSAs as per planned timelines.
• Create and maintain document status reports’ and update department tools/systems and team members on a regular basis; Ensure appropriate documentation is maintained by Ergomed staff assigned to the contracting process.
• Manage site and study level discussions with internal and sponsor team stakeholders around fair market value of investigator budgets and payment terms within corporate and industry standards during negotiation with sites.
• Establish strong working relationships and collaboration with Sponsor to ensure smooth negotiations and repeat business with Ergomed.
• Be accountable for Site Contracts delivery of assigned projects and/or initiatives.
• May oversee people management activities including interviewing and selection, terminations, professional development, performance appraisals, job description preparation, and employee counselling
• Perform other work-related duties as assigned.

Senior Site Contracts Manager

• Oversee the negotiation process of clinical study agreements on assigned trials, acting as SME to sponsors and stakeholders\n• Plan CSA execution strategy in line with study start-up delivery plans and client expectations\n• Prepare CSA templates, payment terms, budgets including fallback positions and negotiation parameters\n• Organize and lead CSA kickoff meetings with Ergomed staff globally\n• Lead CSA negotiations at study level, finalize and execute CSAs per timelines\n• Negotiate directly with sites in assigned countries; escalate out-of-parameter queries as needed\n• Coordinate and maintain documentation status reports and department tools; update team members regularly\n• Manage site and study level discussions on fair market value of investigator budgets and payment terms within standards\n• Ensure smooth negotiations and repeat business with Sponsor; maintain relationships\n• Collaborate with internal and external legal, finance, and clinical operations teams; communicate legal and budgetary issues\n• Be accountable for Site Contracts delivery of assigned projects\n• Perform other duties as assigned\n• Note: UK candidates considered as well.

Site Contracts Manager

Vice President

• As the Senior VP Strategic Solutions and Patient Centricity (SSPC) you will play a crucial role in driving the success of new business proposals as well as clinical trial delivery by combining strategic insight, targeted therapeutic oversight, a patient-centric focus, and industry expertise.
• The role bridges both Operations and Commercial departments, while maintaining its own autonomy.
• You ensure the right structure and environment so that your team can orchestrate the optimal path for successful clinical trial planning and execution.
• This role will lead a team of skilled professionals and collaborate closely with cross-functional stakeholders to shape the course of clinical trials globally.
• Drive overall operational strategy globally, with a focus on our key therapeutic areas of Oncology and Rare Disease, to maximize Ergomed’s revenue and reputation.
• Lead a team of highly skilled professionals, fostering a collaborative and innovative environment.
• Provide mentorship, guidance, and development opportunities to team members, enhancing their capabilities and expertise.
• Leverage your comprehensive understanding of clinical trial dynamics, incorporate the sponsor context, therapy characteristics, disease indications, scientific/medical knowledge, and regulatory requirements, to support your team in the design of strategic plans for successful trial outcomes.
• Collaborate with internal and external experts to incorporate innovative approaches and industry best practices into trial design and planning.
• Work closely with the Business Development department to contribute strategic insights during the proposal and client engagement phases, enhancing Ergomed's ability to win new clinical trial contracts.
• Develop and present compelling narratives that highlight Ergomed's expertise and unique approach to prospective clients, effectively demonstrating the value of our strategic solutions.
• Set up the Directors, Operational Strategy as the owners of the Win Strategy that will be created for every key new business opportunity.
• Ensure the creation of appropriate job descriptions and RACIs to maximize clarity of roles, efficiency of touch points, and levels of authority to underpin the rapidity of informed decision-making.
• Build the Operational and Clinical Intelligence team, by defining the value-added outputs from this team, and structuring the interactions with key stakeholders such as Medical Affairs, and Regulatory.
• Set up the appropriate access to empirical data sources focused on Ergomed’s target therapeutic areas (Oncology and Rare Disease) and develop a system to leverage intelligence from these data sources to inform our Win Strategy.
• Establish the Clinician Engagement function to gather insights from key opinion leaders in diverse geographic regions, to better inform our understanding of the standard of care, the clinician/investigator experience, the attractiveness of the scientific endpoints under investigation, and the viability of the protocol design.
• Promote a patient-centric approach across all stages of clinical trial planning and execution, ensuring trial execution strategies are designed with patient needs and experiences at the forefront.
• Partner with the full gamut of cross-functional operational colleagues to predict, identify, mitigate, and manage potential challenges and issues that arise during study execution.
• Represent the Company by attending industry meetings, speaking engagements, participating in booth exhibitions, etc., and by publishing scientific or industry related articles in industry journals.
• Participates in client development, proposal development, bid defense preparation and bid defense meetings as necessary.
• Establish Ergomed as a recognized authority in clinical trial strategy and patient-centricity within the broader pharmaceutical and clinical research landscape.
• Perform administrative tasks associated with being a department head (e.g., budget oversight, performance reviews, etc!).

Executive Vice President, PV Operations

Executive Vice President, PV Operations

Executive Vice President, PV Operations

Executive Vice President, PV Operations

Executive Vice President, PV Operations

Executive Vice President, PV Operations

Senior Vice President, Marketing

Clinical Project Manager – Oncology and Radiopharmaceuticals

Local Contact Person, Pharmacovigilance and Regulatory Affairs

Senior Vice President, Marketing

Director / Senior Director, Operational Strategy (Rare Disease)

Senior Site Contracts Manager

Site Contracts Manager

Senior VP, Strategic Solutions and Patient Centricity, Oncology