Location: Boston, MA
As a member of the Global Medicines Development & Medical Affairs (GMDA), QA & Regulatory Affairs Technology leadership team, the Senior Director is accountable for the Biometrics & Information Sciences and Real World Data/Evidence (RWD/RWE) technology strategy, portfolio and operations function and oversee a team of highly specialized technology personnel. You will help drive the Data/Technology/Engineering (DTE) mission and be responsible for business relationship management and end-to-end ownership of the technology platforms enabling core capabilities within the following Vertex GMDA business functions: Biostatistics, Statistical Programming; Modeling & Simulation and Real World Evidence. Drives the complete lifecycle management of a portfolio of digital platforms, including SAS Clinical Study Data Platform; CDISC Compliance Platform (Pinnacle21); Patient Monitoring (JReview); Modeling & Simulation Platform (Metworkx & PGxP) and Real World Evidence Computing Environment etc. This role will also develop an overarching long-term vision for digital engagement in alignment with specific GMDA business strategies and in collaboration with our key internal and external business partners.
Key Duties & Responsibilities
- Directs the complete lifecycle of Biometrics, Real World Data/Evidence (RWD/RWE) and Information Sciences technology solutions - defining business need, project planning, vendor selection, development, deployment, and end user adoption and provide ongoing management and functional oversight for all related systems.
- Directs and coaches team members to achieve organizational objectives of an expanding matrix organization and growing pipeline, fostering team-work, demonstrating efficient and clear decision making, embedding principles and values that place patients and quality first, and maintaining a leadership presence throughout.
- Business relationship management and end-to-end ownership of the technology platforms enabling core capabilities in related Vertex business functions.
- Digital Strategy - Define and support an aligned vision for digital Biometrics and Information Sciences & RWE environment. Develop governance platforms for digital engagements across multiple channels and functions. Demonstrates appropriate risk management in context of changing business and regulatory environment.
- Digital Solution Management - Understand the evolving needs of the business, appropriately prioritizes digital demands, and selects appropriate solutions, tools and platforms to be deployed. Navigate a highly complex digital ecosystem in support of global trials, a variety of 3rd party providers, as well as GMDA partners, and delivers timely audit ready solutions that can manage the volume and complexity required by the clinical development plan
- Digital Improvement - Leads a team of technology platform owners ensuring new features and functionality to better serve our business are identified, designed and implemented in alignment with key business areas. Measures and communicates business value, e.g., improved efficiency.
- Expert consultant in support of championing and delivering clinical trial vision associated with being digital from source to submission. Represents Vertex among industry experts and leaders to ensure industry alignments, developing innovative risk-based approaches, and adapting to constantly evolving digital solutions.
- Translates outputs of operational data analysis into clear insights for executive management's consideration. Works with functional leaders to align on key measures and metrics for success.
- Stays current with new developments in clinical systems, drug development, and regulatory guidance, including global regulatory standards for data and document solutions.
- Pro-actively identifies and mitigates key cross-functional and vendor issues independently with limited need to escalate.
- Bachelor's degree in technology discipline or equivalent
- Typically requires 12 years of experience as a leader in information technology or the equivalent combination of education and experience
- 15+ years of team leadership, building strong technical & operations-based teams with business acumen, consultative skills, results orientation and influencing capabilities that derive value.
- Proven experience in Biometrics & clinical data sciences digital strategy generation in a complex business, demonstrating integration & alignment with multiple constituents, functional area strategies and objectives.
- Significant knowledge of broad array of systems including SAS Clinical Study Data Platform; CDISC Compliance Platform; Patient Monitoring; Modeling & Simulation Platform and Real World Evidence Computing Environment; data visualization/reporting solutions as well as data exchange with third party providers.
- 15+ years of experience working in relationship management roles at the intersection of the business and information technology in innovative, technology-driven environments.
- Significant experience in pharmaceutical/biotechnology and extensive knowledge of ICH-GCP guidelines, 21 CRF Part 11, and major Health Authority regulations as they pertain to the operational aspects of clinical studies.
- 10+ years systems development experience informing expert knowledge on clinical trial systems validation, related global regulatory agency requirements, and direct inspection readiness experience audit participation.
- Vendor management accountabilities that drive effective governance, inspection readiness and expected results.
- Demonstrated ability to analyze complex issues, to develop relevant and realistic recommendations and plans, and to drive projects to consistently meet multiple project deadlines while mitigating risks.
- Significant knowledge of portfolio management of critical technology-fueled business programs and projects. Includes creation of integrated annual plans, resource allocations, communication strategies, stakeholder management methodologies and value creation measurement.
- Well networked with technology innovators and industry peers.
- 15+ plus years in a digital program leadership role within pharma/biotech drug development, clinical digital technology company, or CRO. Must include service delivery experience and formal project management experience.
- The Senior Director will have background where he/she has led major global enterprise initiatives that improved the company's technology platforms in a highly innovative and effective way. He/she has built effective relationship with the business and championed new initiatives that broaden and deepen end to end business technology capabilities and resources.
- He/she is a visionary leader with a collaborative leadership style and a proven track record as a champion of technology solutions that transforms business results.
- Change Management:
- The executive is a decisive, action-oriented strategic leader, who should have demonstrated capability to lead large change management initiatives in prior organizations.
- Strong process orientation:
- The Senior Director will have a strong sense of ownership and accountability for achieving results and will continually track performance against key KPIs. He/she will have demonstrated experience establishing clear lines of accountability and driving key decision making processes, which are business-focused and result in the delivery of "game changing" technology-driven business solutions.
- Strategic agility and strong planning orientation, with ability to clearly and convincingly articulate plans that align stakeholders with process and technology.
- An innovator who has experience in building integrated digital solutions and with significant experience in partnering with business and key suppliers in implementing complex tools and platforms.
- Passionate about team development and fostering a positive culture, in a complex environment.
- Extensive business transformation capability with demonstrated expertise in continuous improvement and change management. A track record of consistent high performance in demonstrating organizational impact through measurable improvements across multiple key projects.
- Excellent communication skills with demonstrated ability to simplify complex concepts, produce concise & simple impactful summaries and communicate to the highest levels in the organization as well as diverse cross-functional audiences.
- Customer focused, with ability to maintain an independent view. Proven ability to interpret internal and external customer needs, negotiate and influence.
- Demonstrated ability to effectively represent IT organization in agency and internal audits, upholding compliance and audit readiness.
- Excellent interpersonal skills, ability to develop relationships with key stakeholders, good conflict management and negotiation skills.
- High degree of motivation; results oriented.
- Business improvement qualifications and/or lean six sigma experience/certification preferred
- Strong network of industry contacts that can be effectively leveraged for benchmarking, contacts and perspective is highly preferred
Other Personal Characteristics
- An individual who sets high standards for himself/herself and applies those standards to their team, as well as being capable of coaching and upgrading organizations.
- Emotionally intelligent; realizes and manages the impact of personal style on others.
- Possesses a high level of personal integrity, is passionate, and understands the personal and business value of treating others with honesty and respect. Displays confidence with internal and external clients and colleagues.
- Must be a team player who, through his/her leadership skills, builds confident and highly productive teams and an exceptionally practical and highly collaborative leader who engages business partners in the governance of establishing priorities and lines of business requirements.
- Exposure to international pharmaceutical operations and processes that cross multiple time zones, legal entities and regulatory functions.
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at (see application details).