Director of U.S. Policy & Advocacy at DBV Technologies managing government affairs and patient advocacy efforts. Engaging with key stakeholders and overseeing strategic initiatives in the healthcare sector.
MS
Hybrid Executive Director, Bio S&T Platform, Data, Statistics & Modeling
Posted 4 weeks ago
About the role
- Executive Director leading biologics process strategies for digital transformation in an innovative healthcare company. Overseeing data strategy and integration of analytics in cross-functional teams to enhance operational efficiency.
Responsibilities
- Develop and co-own with Digital Manufacturing a multi-year digital and data strategy for biologics late-stage pipeline and inline aligned with enterprise priorities; translate strategy into a prioritized execution roadmap with clear business cases and ROI metrics., and drive execution against that roadmap.
- Establish approach and drive acceleration of adoption of analytics, statistics, modeling, AI/ML and structured content practices in Bio S&T, while holding functions accountable for execution.
- This role will also be responsible for integrating across the Bio S&T functions in driving a robust knowledge management and document management strategy for CMC filings.
- This will be done in close integration and collaboration with Digital Manufacturing and Digital CMC.
- This role will oversee the integrated data architecture and governance model within Bio S&T that unifies process data across upstream/downstream, scale-up/tech transfer and commercial operations, including external CMOs/CDMOs.
- Serve as Bio S&T functional owner for key lab/process systems across Bio S&T (e.g ELN, utilization of VTN, KX etc); drive adoption and enable cross program learnings.
- Coordinate and sustain maintenance of process platforms and standards across Bio S&T functions, with functions holding content accountability.
- Identify needs, develop biologics tech business strategy for mechanistic/statistical modeling, predictive analytics, digital twins, and support NLP-enabled data extraction driving Bio S&T level execution of Digital CMC strategies, ensuring sustainability and efficiency.
- Drive strong collaboration with Digital Manufacturing to link business and data science & analytics capabilities in Digital Manufacturing.
- Define, track and report KPIs for data quality, model impact, process performance (yield, cycle time, first-pass success), submission timelines and cost savings, while driving execution through Bio S&T functions.
- Drive operationalization of analytics into workflows (experimental design, tech transfer, manufacturing control, lot release) and partner with continuous improvement teams to capture efficiencies.
- Integrate at site technology process data leads and above site process data leads driving to efficient and sustainable execution of overarching biologics data strategy and process monitoring.
- Oversee and streamline statistics support & training across Manufacturing process and analytical working groups, and functions.
- This role will partner very closely with Digital Manufacturing and Digital CMC to drive an integrated strategy for biologics across Bio S&T functions.
- This team will integrate existing local efforts on data management, data strategy, modeling, statistics, data sciences within Bio S&T.
- Drive change and adoption of data and digital mindset within Bio S&T across all functions and all levels of the organization.
- Recruit, develop and retain a multidisciplinary team; champion inclusive talent management and succession planning.
Requirements
- 10+ years industry experience in biologics process development, manufacturing, CMC or related functions, with substantial experience leading enterprise digital/data transformation.
- Demonstrated experience building COEs or comparable cross-functional organizations, implementing enterprise data strategies and integrating external manufacturing data.
- Strong domain knowledge of biologics upstream/downstream processes, PAT, analytical workflows, tech transfer and regulatory expectations.
- Technical fluency with data architectures and ability to interface with IT and Digital CMC.
- Proven track record delivering measurable cost and process improvements from digital initiatives; strong financial acumen for business case development.
- Exceptional leadership, communication and stakeholder management skills; success operating in matrixed environments and partnering with Quality/Regulatory teams.
- Ability to work through influence, action orientation and drive change.
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
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