General Description :
The Director of Global Medical Affairs Program Management Office (GMA PMO) will serve as the head of Medical Governance and Operations. In this role, the Director will work toward standardization of key operational activities across Global Medical Affairs (GMA) and provide Project Management support for the GMA Leadership Team. The Director will also have accountability of the following medical processes: Global and US Medical Review Committee process, Global and US Medical Education Grants Review Committee process, and Global and US Contracting process. This role will work closely across all functions, franchises and regions within Medical, as well as engage with key cross-functional partners including Compliance, Finance, Procurement, Regulatory, Quality, and Commercial.
The Director will ensure the delivery of results on-time and within-budget, while driving effective communication within the team and to key stakeholders. As an integral member of the growing PMO and Global Medical Excellence team, the Director will also lead other projects and initiatives to support standardization, optimization, and evolution of medical processes and governance.
The ideal candidate is a problem solver who has a strong Medical Affairs Operations background and is able keep the big picture in mind even as they support day-to-day tactics. The candidate must be an excellent communicator and have exceptional skills organizing and synthesizing information. Additionally, the candidate should thrive in an entrepreneurial environment and demonstrate a high level of initiative and resourcefulness.
This position will report to the Vice President of Global Medical Excellence within GMA.
Essential Functions of the job:
Manages the Global and US Medical Review Committees and is accountable for the MRC Global Policy and process
Manages the Global and USGrants Review Committeeprocess including execution of Medical Education, IME, CME, Grants, Sponsorshipsand helps to shapethe overall process
Facilitates the review, approval, and delivery ofenterprise and GXPtraining to Medical Affairs personnel, including during onboarding(excludes scientific training on data, publications, disease-state, and competitors)
Lead and supportcontinuous improvements efforts in the PMO by sharing best practices,identifyingcross-projectand cross-functionalopportunities/interdependencies/risks, assessing key performancemetricsandestablishingstandardizationacross GMA
Provide Project Management of GMALT andoperational initiatives supportingthe GMA Leadership Team, including planning of Global Town Halls and othercross-GMAteam meetings
SupportsVice President of Global Medical Excellencein management ofbudgetsacross GMA
Support contracting processin Global and US, ensuring allregions are following best practices
Serve as a liaison to keycross-functional partners including Compliance, Finance, Procurement, Regulatory, Quality, andPRC
Proactivelyidentifiescritical milestones, interdependencies,risksand resource constraints that couldimpactplans/timelines and collaborates with teams to developappropriate solutions
Creates andmaintainsproject timelines that are critical tools for tracking progress against goals; closely and transparently manages the critical path of projects
Effectively communicates actions, decisions, timelines,risksand changes toplans
Effectively manages and/orfacilitatesvarious meetings and manages meeting documentation (agendas, minutes, action/decision trackers, etc.)
Drives use of consistent project management tools and practices
Partners with non-GMA stakeholders (e.g., Finance,Procurement, etc.) to drive execution
Effectively and quicklyestablishesrapport with all key internal/external partners and stakeholders and influences without authority
Optimizescommunication within and between teams, in and outside of meetings, and at varying organizational levels
Develops and delivers critical presentations to communicate medicalprocesses and governance
Adept at learningnew technologiesand platforms
Ensure compliance with corporate policies and procedures, as well as US healthcare laws and regulations
Education Required:
Bachelor's degreeisrequired,advanced degrees (Master's Degree, PhD, PharmD) are a plus
Qualifications:
BA/BS degree with 10 + years of experience or a Master's or higher with 7 + years of experience within the pharmaceutical,biotechor life sciences industry
6 + years of experienceworking ina project or program management roleor in Medical Operations
Industry experience -astrong understanding of the biotech/pharmaceutical industry andpreviousdrug development experience isrequired.
Operationalexperience within Medical Affairs isrequired. Oncologytherapeutic areaexperience preferred
Analytical Thinking -possessesthe ability to breakdown a problem and implement a scalable solution that takes long-term strategy into account
Excellence in Execution - ability toexecute accurately andwith a sense of urgency; strong organizational skills and attention to detail
Initiative andResourcefulness - works independently,anticipatesneeds to help mitigate problems ahead of time, and solves problems without needing guidance/direction
Communication-excellent writing and oral communication skills; ability to present key information objectively andclearly
Meeting Management - excellent meeting planning and facilitation skills
Project Management - highly proficient at both building andmaintainingGantt charts, tracking systems, spreadsheets and tools that support a systematic and scalable approach to managing projects
Problem Solving -A proactive and effective problem solver who works well with others; proven ability to manage complex and challenging situations to drive to clarity
TeamPlayer-has ateam-oriented approach
BusinessSense - has a strong business sense and can decipher priorities and make sound judgment calls when needed
Proficiencywith Microsoft Office applications (e.g., Outlook, Excel, Power Point) isrequired
Proficiencywith Smartsheet is preferred, competency isrequired
Familiarity with VeevaMedComms, VVQD,Cybergrantsare all a plus
Project Management certification is a plus
Supervisory Responsibilities:
Yes, supervisory experience preferred
Travel:
Work-related travelwill be less than10%.Over-timeand weekendtravelmay berequiredon occasion.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
