Operations Leader - Global Medical Affairs
25 W. Watkins Road Ã¢ÂÂ 403A Gaithersburg, Maryland 20878
Operations Leader, Global Medical Affairs
Lead the delivery of a portfolio of Company and Non-Company sponsored studies and manage the cross functional activities required for granting Early Access to Investigational Medicinal Products up to 6 months post marketing authorization approval within any defined market, region, institution and/or therapeutic area(s). Ensures compliant and appropriate adherence with all relevant Company policies/procedures, local and international regulatory and legislative guidance for the different procedural frameworks as well as when operating with external organizations. Company Sponsored Observational and Interventional Research projects: Ensure delivery of portfolio projects by effective collaboration with the Delivery Directors, Epidemiologists/MALs and other internal cross functional global functions as well as selected External Service Providers (ESPs). Contribute to the selection and review of External Service Providers (ESPs) to ensure high level return on investment through initial RFP review and subsequent ESP selection, agreement on significant out of scope changes and general high level issue management. Ensure the operational aspects of Clinical Research Organization (CRO) collaboration are effectively undertaken. Undertake feasibility assessments on company sponsored study proposals Ensure the CRO commitments are delivered. Work with Marketing Company (MC) resources where required to ensure that commitments are delivered. External Sponsored Scientific Research (ESR) Projects: Provide oversight to MC ensuring all operational aspects of ESR delivery within agreed timelines and budgets, and in line with the legal and compliance requirements for non-company sponsored research. Lead and Manage the delivery of complex multi-product/country/cross regional ESR Collaborative Research studies. Early Access programs/Named Patient Supplies (NPS): Lead the NPS cross functional team interactions Ensure all relevant documentation is in place for timely review and decision making of NPS requests.
Company Sponsored Observational and Interventional Research:
• Contribute into the planning of projects where required, by coordinating protocol development in collaboration with the Epidemiologist/Medical Affairs Leader (MAL)/external medical writer (if applicable) to make sure input of all relevant internal, cross functional and external stakeholders into the study design is obtained.
• Contribute to CRO selection and award (bid defense)
• Assure that studies proposed are feasible before a project commitment is made.
• Assure that study feasibilities are completed, assessing several delivery options (e.g. cost, time) and include appropriate risk analyses.
• Ensure global oversight over the operational study start up and implementation
• Deliver projects to agreed timelines (scorecard), within the approved budget and respecting the quality standards.
• Ensure the final development and implementation of study risk mitigation plan and actions.
• Ensure internal reporting of compliance issues as per process
• Act as a contact point to assigned ESP/CRO teams on specific projects ensuring they have clear remits for delivery, and manage their deliverables to reflect the agreed priorities across the portfolio.
• Act as the key contact point for Stakeholders.
• Manage study specific issues and conflicts with ESPs/CROs.
• Work with the Delivery Directors to judge the impact of new requests or project changes on time, cost and quality on deliverables to ensure they are realistic.
• Ensure an effective communication plan exists and is implemented between the MEOR stakeholders and External Service Providers, so that the business need of information exchange occurs, whilst ensuring minimal resource is required to develop and support this activity.
• Manage study finance appropriately:
o Collaborate with procurement to set up and keep contracts with ESP’ s up to date and accurate in accordance with the agreed scope o Keep track of CRO and other External Service Provider’ s (ESP’ s) budget, managing scope and change orders where appropriate
o Keep track of study budget on an ongoing basis (expense tracking)
o Complete finance management systems (ACCORD) and collaborate with budget holders to ensure full transparency on study budget and obtain approval for budget changes associated with changes in scope
• Ensure appropriate level of involvement of the external scientific community (PI, NPI, Steering/Executive Committee) in the project design and delivery External Sponsored Scientific Research (ESR):
• Acts as the first point of contact for MC operational research enquiries, ensuring that proposal guidelines and standards are met, escalating the proposal as appropriate to the relevant TA director
• Supports/Coordinates the review of External Sponsored Scientific Research (ESR) proposals to enable a consistent, high quality approach to evaluation e.g. gathering required data from MC
• Co-ordinates complex external research in conjunction with MC, overseeing Medical Affairs specialists and/or study management specialists to ensure compliance with project management guidelines, external regulations and internal processes/policies to enable high quality research projects. This includes overseeing the launch of new clinical trials
• Leads the project management of complex joint research projects ensuring compliance with project management guidelines, external regulations and internal processes/policies to enable the delivery of high quality Investigator Sponsored Research and Externally Sponsored Collaborative Research. This includes co-ordination of resource identification and allocation, overseeing the launch of new clinical trials and the initiation/maintenance of supplier contracts
• Lead product supply forecasting process, engaging key stakeholders across 3 science units as applicable to ensure timely supply availability to markets.
• Revises all project planning in light of changing needs and requirements to ensure that deliverables continue to be efficiently and effectively met and continued compliance
• Tracks all project time, cost and quality KPIs, taking corrective action as required to ensure that project targets are met
• Oversees the development of final research evaluation reports, ensuring compliance with reporting publication policies and guidelines.
• Lead project finance forecast and budgeting for assigned projects/portfolios, utilizing appropriate Company systems. Early Access programs/Named Patient Supplies (NPS):
• Lead the NPS cross-functional team interactions - Outsourcing partner, triaging physician, Chief Medical Office (CMO) representative and Pharmaceutical Development to secure all documentation is in place for timely review and decision making of NPS requests. Minimum
Bachelor’ s degree required preferably in medical or biological science or equivalent by experience.
Extensive pharmaceutical industry/CRO experience within clinical study/research project delivery, drug development process and relevant guidelines, for example GCP/ICH, for a specific therapeutic and geographical area.
Project Management qualification or demonstration of project management skills including scope, budget, timeline, resource management and use of associated tools.
Scientific awareness and extensive knowledge of observational study guidelines and SOPs
Extensive knowledge of early and late stage Pharmaceutical Development
Ability to effectively work with Clinical Research Organizations/External Providers.
Proven ability to interact widely and effectively within the company across regions, functions and cultures.
Experience and knowledge within compliant management of Externally Sponsored Scientific Research
Persuasive communicator in English with a proven ability to work collaboratively in a multi-cultural environment
Open to periods of travel
Ability to demonstrate corporate values in the day to day work
Proven leadership promoting motivation and empowerment of others in order to accomplish organizational objectives in a matrix environment
Manages change with a positive approach to the challenges of change for self, team and the business. Sees change as an opportunity to improve performance and add value to the business.
Excellent written and verbal communication skills, negotiation, collaboration and interpersonal skills
Good problem solving and conflict resolution skills
Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a global and regional environment
Ability to understand and summarize complex, medical data
Ability to identify and champion more efficient and effective methods/processes whilst operating with required policies and regulations
Flexibility and adaptability
High levels of enthusiasm and energy
Integrity and high ethical standards