Executive Director, Program Management (Biotechnology Oncology)
PharmaBiotechRegulatory AffairsQuality Assuranceemacroinform
Job description
SUMMARY/JOB PURPOSE The Executive Director, Program Management is a key leadership role with substantial strategic input. As a seasoned program leader, the executive director of program management demonstrates a mastery of core and technical competencies, navigating myriad of complex and ambiguous therapeutic area scenarios. The Executive Director, Program Management partners with team leaders on highly complex programs and leads enterprise-level programs and initiatives involving senior and executive level stakeholders. This role serves as a key leader in the Program Management function and is expected to manage or lead a team of direct reports. The Executive Director, Program Management partners with Team Leaders and cross-functional teams to manage multiple highly complex Discovery and Translational Research (DTR), CMC and Development programs, spanning from Discovery to Phase 1 to 3 development, CMC, NDA/BLA filings, and approvals. This position plays a critical role in the development and execution of program strategy and leads the creation and implementation of team processes to enable the timely delivery of program goals and deliverables. Develops and maintains integrated project plans, Gantts/timelines, status reports, strategic development and filing plans in collaboration with team leaders and cross-functional team members. Oversees and manages the operational aspects of ongoing drug development projects to ensure goals and objectives are met. Acts as a strategic thought partner to team leaders as well as executive level functional leaders across the organization. ESSENTIAL DUTIES/RESPONSIBILITIES Oversees multiple highly complex projects or initiatives, or a portfolio of discovery and translational research (DTR), CMC, Phase 1 to 3 clinical development, NDA/BLA filings/approvals and/or post approval programs. Leads and ensures product strategy alignment across cross-functional teams and beyond team member level. Develops detailed cross-functional integrated project plans, Gantt charts and status reports of key deliverables for project, portfolio and enterprise-wide planning. Understands timeline interdependencies between functions and accurately captures key milestones and critical path. Proactively highlights and captures risks and implements efficiencies. Captures and clearly articulates dependencies of key milestones on critical path. In collaboration with Finance and team leader, keeps track of project resources and budget and schedules appropriate governance approvals. Identifies risks impacting success of TPP and helps the team with mitigation plans. Oversees risk management and contingency planning for the team, ensuring proactive identification and resolution of issues; navigates uncertainties with agility and accountability. Escalates risks to stakeholder, supports enterprise-wide initiative to define risk management process. Communicates effectively with executive leadership and governance bodies, providing clear, concise updates and recommendations; sets clear meeting agendas, facilitates meetings, writes clear minutes, assigns action items, follows up on action resolution. Oversees department initiatives to establish and implement processes and documentation best practices. Leads departmental or organizational initiatives, manages FT or governance bodies, creates and implements processes and templates as needed. Proactively identifies gaps in processes, develops proposals and implements solutions to address as needed. Can prioritize critical solutions and address stakeholder concerns. Maintains strong external awareness of scientific, regulatory, and commercial trends and understand impact on portfolio programs. Communicates relevant information, highlighting relevance to departmental or cross-functional team. Performs other duties as assigned Complies with all policies and standards SUPERVISORY RESPONSIBILITIES Directly supervises employees or leads a team of direct reports. EDUCATION/EXPERIENCE/KNOWLEDGE/SKILLS & ABILITIES Education BS/BA degree in STEM or related discipline and a minimum of 18 years relevant experience; or, MS/MA degree in STEM, biological or pharmaceutical sciences and a minimum of 16 years relevant experience; or, PhD in STEM, biological or pharmaceutical sciences and a minimum of 15 years relevant experience; or, Equivalent combination of education and experience. Experience 15-18 years of experience managing cross-functional teams in biotech/pharma, including CMC, discovery or development. Minimum of 5 years of experience managing at the Director level. Experience managing small molecules/biologics in cancer immunology and/or oncology fields is preferred. Has experience working with BD or alliance management on a deal. Past experience leading deals or managing corporate partnerships or alliances is a plus. Extensive experience of the full Discovery, preclinical and clinical development across all stages, including CMC activities, and filing support process (oncology is preferred). Experience in at least two different functions or phases of development preferred. Knowledge, Skills and Abilities Required: Exceptional analytical skills with an ability to summarize and present complex information in a clear and concise manner including clarity on prioritization and criticality of topics discussed. Able to drive complex decision making processes. Excellent verbal and written communications, presentation, collaboration and negotiation skills. Excellent leadership and influencing skills at departmental, organizational and cross-functional levels. Shows excellent drive and self-motivation, sets a fast pace for self and teams while maintaining strong relationships. Excels in motivating others in a fast-paced environment. Excellent organizational and efficiency skills, excellent attention to detail. Processes significant amount of complex technical and project related information rapidly. Is an excellent role model, leads by example and is a strong advocate for Exelixis' mission, vision and corporate values. High proficiency with MS Office Suite, Planisware, MS Project or equivalent project management software. Core competencies:*Leadership: A seasoned leader, capable of managing significant complexity and has clear vision based on big picture understanding of company strategy and context. Develops and mentors emerging leaders.*Communication: Excellent skills in reducing complex topics and issues to simpler components. Excellent ability in providing context, identifying and articulating key messages without being lost in details. Excellent in being able to see and articulate the big picture. Excellent skills in identifying the right audience and the right forum for communications. Excellent skills in promoting open and honest communications.*Influencing and Persuasion: Excellent understanding of the company's organizational structure and culture. Excellent ability to gain support for business ideas at departmental and cross-functional levels. Excellent negotiation and listening skills. Technical competencies:*Project Management: Excellent understanding of program management trade-offs, scope, timelines, budget/resources and quality. *Excellent technical knowledge and a record of execution in either discovery, CMC or development and solid breadth in drug development process, including product franchise knowledge. Is well known for deep expertise in several relevant R&D disciplines. Demonstrated experience in building long-term program strategies. *Drug development: Excellent knowledge of th
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