Celgene Director, Medical Affairs Systems Strategy & Operations in Summit, New Jersey
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
The Medical Affairs functions within Celgene are responsible for multiple activities, including:
• Developing medical disease strategies across all therapeutic areas of interest
• Responding to inbound medical/scientific queries from internal/external customers through multiple channels
• Planning and presenting/publishing scientific/medical data to inform the healthcare and payor communities
• Evaluation and provision of educational grants to organizations focused on enhancing patient care
• Managing relationships with key customers/institutions including academia, research organizations, patient care groups
• Commissioning drug studies; evaluation and provision of grant or drug substance to Investigator Initiated Trials
• Organization and provision of external research data to support Celgene’s scientific and medical objectives
• Aggregating and synthesizing customer insights to support informed decision making throughout the company
Medical Affairs (MA) has developed a Systems Roadmap, designed to revolutionize the functional performance of the medical business processes and information systems capabilities. MA functions across Celgene will develop and implement business processes and IT systems that are robust, global, structured but flexible, and capable of taking the organization into the future with a focus on the next 5-years as well as beyond.
The MA Roadmap Strategy (MARS) comprises multiple programs that will change business processes where necessary, organize data strategically, and fully leverage effective technology solutions. It will serve multiple geographies, therapeutic areas, and functional groups within and outside MA requiring the consideration of significant organizational, cultural, operating model, practical and personal challenges to be faced by the MA colleagues and their customers/stakeholders. This position will serve as the business lead in the development, support and governance of MARS.
Additionally, this individual will be responsible for the management of the Medical Affairs Integrated Platform, a community of systems that support Medical Affairs activities such as IIT Management, Medical Information requests, Publications, Educational Grants, Medical Content, multi-channel delivery and cross-platform reporting and analytics. This individual will represent the platform across Celgene and lead governance with business and IT. It will be important for this role to gain alignment and streamline activities across the platform to support the diverse user population.
This role will represent MARS and the Medical Affairs Integrated Platform globally in cross-functional and cross-regional meetings to promote worldwide user adoption.
- Serves as Business Lead of the Portfolio Enablement Committee (PEC) that provides governance, management, operational support and infrastructure to enable achievement of the Roadmap solutions and benefits (includes project management, financial tracking, risk and issue management, design authority and vendor management)
• Ensure all levels of governance are aware of roles and responsibilities to achieve success of MARS
• Fosters awareness of MARS among global, regional, and local MA constituents to ensure a coordinated, worldwide effort and alignment on new ways of working
• Support business in identification and documentation of emerging needs or capability gaps and develop a business case for governance review.
• Develops and implements a robust and targeted communication plan that addresses the need to manage the flow of information in a timely and effective manner across all geographies and levels
• Identifies, analyzes and manages stakeholder groups to support the organization through change (e.g. people, process, technology) on an ongoing basis
• Enables impacted stakeholders to use new technology together with related business processes, policies, and/or procedures to effectively carry out their day- to-day function
• Ensure benefits realization statements are included in all new program/projects charters and are presented to the governance teams following project completion to ensure return on investment for new technology solutions is being assessed regularly.
Participates in regular design and implementation reviews so that any potential challenges are identified and mitigated early
Represents Medical Affairs in Celgene initiatives such as Master Data Management, Taxonomy and global corporate technology solutions
Identifies, with colleagues, changes in business circumstances and/or opportunities that may require adjustment of MARS. Works with the PEC on completing the impact assessment and identifying alternative solutions
Participates in RFPs, vendor evaluation, and selection of business solution and external resources to meet internal skills/resource shortfalls
Conducts business in accordance with Celgene Values. Completes all assigned SOPs and training within designated timeframe and adheres to job-specific SOPs and work instructions
Medical Affairs Integrated Platform Lead Responsibilities:
Responsible for the business ownership, overall management and oversight of the Medical Affairs Integrated Platform
Lead the platform governance at all levels; informs Medical Affairs Integrated Platform executive sponsors and leadership of new and existing projects including status updates, risk identification and mitigation, financial impacts, communication plans and any escalations as needed.
Lead global cross-functional interaction within and beyond MA to ensure optimized processes, consistent performance, and quality related to information maintenance and reporting across the Platform.
Leads the definition of business processes and development/refinement of “best practice” procedures to influence proper usage of the Medical Affairs Integrated Platform.
Through governance, lead the MA and IT support team to elicit information/ideas, analyze gaps/recommendations document/communicate/validate business needs/requirements for changes to the business processes, policies, and/or Medical Affairs Integrated Platform.
Ensure all established business and IT processes are followed in system build, launch and enhancements.
Develop and implement plan to make routine system enhancements and ensure the plan is followed by individual system (owners) and IT, with all deviations documented
Line management of Medical Operations System Owners and other systems support team members
Responsible for communicating cross platform issues, updates, and information to the end users in a timely, effective fashion.
Develop and deliver training on platform level updates and changes; oversee individual system training development and delivery.
Oversee integrations and data feeds into and outside of Medical Affairs Integrated Platform to ensure all business needs are met through partnership with appropriate business contacts.
Oversee delivery of business requirements for all systems on platform to IT and ensure they are tested and implemented effectively.
Oversee development of reporting and analytics module, including development and maintenance of system specifics tools and reports that assist in identifying signals and trends in MA data to promote informed decision making.
Actively engage with end users to gain continual feedback on Platform and any recommendations for improvement to ensure optimal use and execution of business process.
Serve as a subject matter expert within MA for Platform
Creates and implements departmental SOPs regarding processes and procedures necessary to achieve organizational objectives and for complying with government regulations and company policy. Evaluates adherence to policies/procedures and institutes corrective action when needed.
Attends external meetings and educational seminars to enhance technical knowledge and broaden pharmaceutical industry experience.
• Advanced degree in life sciences, business, IT, or general management
Industry-based Medical Affairs or Clinical experience preferred
• Minimum of 8 years of business process, IT experience and/or consulting
• Strong stakeholder management experience required
• Strong project management experience required
• Demonstrated experience managing large scale change and technical implementation in a matrix environment
• Demonstrated record of leadership, professional advancement and accomplishments
• Ability to work collaboratively with multidisciplinary business and IT teams
• Self-motivated with exceptional follow-through
• Thorough knowledge and experience of successfully implementing new business capabilities for MA or similar Pharmaceutical R&D and/or Commercial organization
• Excellent written, verbal and interpersonal communication skills
• Flexible, with positive attitude, strong ability to multi task, prioritize projects effectively and communicate at all levels within the company
• Proficient with Risk and Issue management and resolution
• Proficient with business process, operations, and metric definition best practices
• Experience with Program/Project Management or equivalent experience, ideally in a cross-functional technical delivery capacity
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.
Director, Medical Affairs Systems Strategy & Operations
Location: Summit, NJ, US
Job ID: 17000968