ERGOMED

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!).

Director / Senior Director, Operational Strategy (Rare Disease)

Senior Site Contracts Manager

Site Contracts Manager

Senior VP, Strategic Solutions and Patient Centricity, Oncology