The Medicine Team Lead (MTL) for Benign Hematology is responsible for leading the cross-functional Global Medicine Teams for Benign Hematology assets from Proof of Concept (POC) to First Major Approval, and co-leads the team following first major filing through to end of lifecycle to deliver additional Life Cycle Management (LCM) development activities.
The MTL is the single point of accountability for timely, cost-effective and high quality execution of project deliverables and decision-making for post-POC assets, maximizing the long-term value of the medicines through development of integrated strategies and aligned execution plans which cover all aspects of drug development - Commercial, Clinical, Medical, Regulatory, Manufacturing, Access, Project Management and Operations.
The MTL Franchise responsibilities will also include leading above asset strategic decision making for the franchise including product concept development and maintenance, transition planning for advancing assets and leadership of technical due diligence for Business Development opportunities.
The MTL may have direct reports including, Global Clinical Leads and/or administrative partners.ROLE RESPONSIBILITIES
• Leads the cross-functional GLOBAL MEDICINE TEAM (GMT) responsible for maximizing the long-term value of the medicine.
• Integrates GMT deliverables and serves as the single point of accountability for the medicine within Global Product Development (GPD); is the point of contact and program representative to executive leadership, governance and other decision-making bodies.
• Drives creation of the Medicine Plan, setting global strategies and aligned operational plans which are built based on global customer insights to maximize the value of our medicines to customers.
• Creates an inclusive environment to ensure input from all team members, regions, lines, and management is heard, validated and considered throughout the lifecycle.
• Manages interactions with internal stakeholders and governance bodies on behalf of the GMT; ensures transparent information flow internally and externally.
• Continuously drives quality, cost and speed improvements, and makes necessary tradeoff decisions to maximize asset value.
• Proactively manages medicine-related events, risks and opportunities.
• Franchise responsibilities will also include leading above asset strategic decision making for the franchise including product concept development and maintenance, transition planning for advancing assets and leadership of technical due diligence for Business Development opportunities
• Will use medical knowledge and acumen to guide asset and franchise level decision making
Strategy and Execution for Each Program within Remit
• Manages the overall medicine/asset budget within GPD; makes investment decisions and trade-offs across the program.
• Drives execution of strategies and programs to maximize medicine/asset performance including:
o Program Delivery - Accountable for delivering program milestones in a timely, cost-effective and high quality fashion (including de-risking assets and investments as early as practical).
o Risk Management - Pro-actively and continuously identify and communicate program risks; develop and implement risk mitigation strategies and resolve critical program issues.
o Resource Management - Work with leaders across functions to ensure that projects have appropriate resources and technical expertise to meet strategic objectives.
o Program Management - Accountable for ensuring that the program is managed appropriately within budget and that resource forecasts for all activities across all functions are accurate and up to date
• Accountable for driving technical review for the program and driving overall due diligence related to the program
• Maintains scientific and regulatory awareness to ensure that project plans reflect the latest scientific/medical developments and regulatory/commercial environment.
• Creates, leads and delivers continuous improvement strategies to improve productivity and increase asset value.
• Ensures the articulation of appropriate standards and specifications for input to contracts with vendors, suppliers and industry partners to deliver the project.
• Drive effective operation of the GMT to ensure flawless execution of programs and activities across functions and regions.
• Create and/or lead a motivated, committed and engaged GMT. Model and expect effective team behavior to achieve the program goals.
• Accountable for decision-making (strategic, operational, and budgetary) within the GMT for the medicine/asset. Effectively leverages the expertise of GMT members in challenging the status quo, providing decision-making recommendations and effectively resolving conflict.
•Develops an effective and collaborative work environment across Categories, GPD and partner lines. Ensures that inputs from all GMT members, regions, lines and management are heard, validated and considered throughout the program lifecycle.
• Manage internal relationships (e.g., platform lines, other BUs) and external relationships (e.g., customers, regulatory agencies, key opinion leaders) either directly or through appropriate medicine team members. Serve as medicine champion by negotiating with and influencing key internal/external stakeholders.
• Engage executive leadership regarding strategic issues, project plans, options and recommendations to support uninterrupted program execution.
• Lead development strategy for SCD area including product concept development and maintenance
• Lead transition team for advancing assets through collaboration with project leaders and managers in Research & Development and/or with licensing partners ensuring a seamless transition of potential medicines through development, registration and/or commercialization.
• Work in concert with appropriate GMT members to build a network to key opinion leaders to support program development and commercialization.
• Lead technical due diligence for Business development opportunities within Benign HematologyBASIC QUALIFICATIONS PREFERRED QUALIFICATIONS
- Minimum of 10 years drug development experience and expertise
- Track record of high performance in a relevant discipline within pharmaceutical development and/or commercialization.
- Experience leading development or medical teams.
- Experience managing the drivers of commercial value in a medicines development, medical or commercial role.
- Experience with the process of developing a competitively superior product label.
- Knowledge of regulatory review and response processes.
- Regulatory filing experience (eg, MAA, BLA)
- Proven management and leadership skills.
- Demonstrated initiative, creativity, strategic capabilities, and strong analytical and financial management skills.
- Ability to lead by example and effectively implement strategies through influence and persuasion of executive leadership and internal/external stakeholders.
- Ability to lead effectively in a cross-functional, matrix team environment. Ability to manage team dynamics and to recognize when team interventions are required to enhance team effectiveness to ensure delivery of program deliverables.
- Ability to work on multiple tasks and prioritize effectively in order to successfully deliver activities against all revenue, cost, time and quality requirements.
- Ability to lead and implement continuous improvement strategies.
- Possesses enthusiasm, energy, confidence and outstanding communication skills.
- Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
Ability to perform complex data analysis.NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
International travel required.
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