Director | Senior Director - Operations & Strategic Programs
The Lead, Operations and Strategic Programs (Lead OSP) will be responsible for providing leadership and operational oversight within Medical Organization to ensure cross-functional alignment, to close strategic-execution gaps, respond to critical business needs & optimize decision-making. He/she will drive alignment and synergy across the Medical Organization by evaluating standard practice improvements and implementing new business-related processes to achieve key business objectives. In order to increase the value of the Medical Organization in support of our brand products, he/she will build new capabilities and create innovative programs which capture and leverage customer-facing insights.
The Lead OSP will be accountable for the performance and results of individuals and activities including: cross-functional strategic programs, investigator-initiated research and educational grants. He/she will be responsible for the operational aspects of running the Medical Organization, providing vision, leadership, and mentoring across the various operational functions in the CMO organization to ensure medical initiatives are successfully implemented according to all relevant regulatory and compliance standards. In addition, the individual is responsible for reviewing and evaluating business procedures to ensure efficient and effective organizational operation.
- Apply broad, in-depth Medical management expertise to assist each of the functions in the Medical Organization to translate functional area strategies to operational and organizational objectives; evaluate & resolve cross-functional business challenges; and set priorities to meet stakeholder needs.
- Direct the annual strategic planning process to ensure medical projects are aligned with company priorities and that resource allocation reflects the relative importance of therapeutic areas and products. Maintain alignment between the Medical Organization and commercial functions in a way that achieves collective goals and respects/maintains compliance with corporate policies and regulations.
- Lead and manage the team tasked with insuring compliant execution and maintenance of IIR and educational grants, supporting the logistics of Grant Review Committees and interfacing with external entities involved.
- Drive the development, alignment and execution of the Medical Brand Plan across the Medical Organization to shape product’s cross-functional, life-cycle strategy and planning in concert with the Program Management.
- Acquire and develop talent to cultivate and build a strong, multi-faceted operations organization and encompass the competencies required to navigate the organization & healthcarelandscape. Maintain a competitive organizational structure and supervise departmental recruitment initiatives to guarantee optimal resourcing for execution of medical initiatives.
- Lead the evaluation, recommendation, and presentation of standard practices and process improvements to ensure processes are harmonized and best practices are implemented across all therapeutic areas and all functions reporting to the CMO.
- Interface with Finance on forecasting and budgeting activities ensuring accurate planning and monitoring of spending and headcount, and provide recommendations to increase cost flexibility and achieve financial targets. Ensure departmental contracts and purchase orders are compliantly executed, a system for tracking of project milestones is established and maintained, and the departmental budget is tracked.
- Provide CMO and his direct reports with timely updates on progress and changes in scope, schedule, and resources across therapeutic and functional areas.
- Interface with Program Management in the creation, execution and tracking of pre-launch and launch readiness plans including the appropriate performance metrics ensuring cross-functional communication, driving strategic decision-making, and identifying actionable opportunities.
- Ensure compliance with company policies with regards to all functional team activities and engage and advocate to the business the criticality of these.
- Develop and lead a cross-functional Strategic Insight Program which establishes a set of measures, processes, and technology to capture medical and scientific insights from all the functions in the Medical Organization, working with functional leads on insight analysis, dissemination to stakeholders, and plans of action
- Partner with the VP of Field Medical Affairs to develop and lead a FMA Operations unit within the Operations & Strategic Programs group responsible for operations support for the field teams (MSLs and Clinical Specialists) with regards to training, scientific resource development, management of the CRM and othertechnologies, insight collection/analysis/dissemination, field metrics and score cards, and overall alignment with the headquarters team on objectives and strategies
- Collect and communicate performance measures for the Medical Organization across all functional and therapeutic areas. Monitor performance measures and take appropriate actions when necessary.
- Coordinate with the Director of Medical Alliance to provide therapeutic knowledge or expertise on business development projects, and drive and manage medical integration process after deal completion.
- Develop and manage a first-in-class medical training program; utilize company resources, to successfully execute medical training program for headquarters and field teams.
- Manage the overall performance of Medical Operations personnel.
- Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
- Perform other related duties and responsibilities as assigned.
Advanced degree in science or Bachelors with 15years relevant experiencerequired
Master of business administration (MBA) preferred
Project Management Professional (PMP) certification preferred
- Minimum 10 years pharmaceutical industry experience
- Project management experience in a regulated healthcare industry required
- In-depth knowledge of Medical Affairs and customer-facing team operations
- Ability to evaluate key business challenges and develop strategies to resolve them cross-functionally
- Broad knowledge of disciplines across the organization to promote synergy and strategic/operational alignment
- Ability to work in a fast-paced, dynamic environment; works well under pressure
- Applied knowledge of project management tools and processes (e.g. management of integration, scope, time, cost, quality, human resources, communications, risk, and procurement)
- Experience with developing and measuring performance outcomes (e.g. metrics, dashboards)
- Understanding of clinical trial design and working knowledge of cGCP guidelines, particularly concerning Investigator initiated research. Must be committed to full compliance with all company SOPs, regulatory requirements, and applicable laws
- Strong leadership skills and demonstrated ability to influence and direct others; capable and enthusiastic about managing and mentoring
- Ability to communicate clearly, and demonstrate vision and commitment; strong interpersonal and communication experience with the ability to effectively interface across all levels of the organization
- Must think strategically and drive programs forward with the ability to weigh both the short- and long-term impact of decisions
- Highly detail-oriented with excellent follow up skills
- Demonstrate integrity and trust to develop and mentor individuals across the organization