Shienal Patel Email & Phone Number

San Francisco, Ca, Us

Campbell, Ca, Us

South San Francisco, California, Us

- Accountable and responsible for leading internal Steering Committee(comprised of Clinical Science, Safety Strategy Lead, Lead Statistician and Product Technical QPL), overseeing various working groups related to device drug program- generation of sustainable processes for continuous image review with internal and external stakeholders- Evaluating and performing ongoing data analysis to support improvements, training and key messages to enable success with surgical and follow up procedures- Influence and garner support for ongoing collaboration with product technical, medical affairs and PD to support internal and external communications with knowledge sharing, for example- EACs, investigators- Garner support needed to help teams’ complete activities and drive to conclusions/decision making while influencing without authority via close partnership with cross functional colleagues to ensure alignment and empowering decision making- Clinical Science representative for the surgical training university team- Creating continuous education for our Retina Surgeons in the global field via Surgical learning series of lectures- Creating ongoing training needed internally- Support early stage development programs i.e.CDP design, evaluating FDA & EMA feedback, data driven decisions based on analysis conducted from existing available data- Close collaboration with late stage to establish learning from trial executions to support activities for upcoming Ph I study and future Ph III studies- Using opportunity to support beyond Ophthalmology TA with product Quality Assurance Head- Supported authoring of PIP/PSP application submissions for pediatric plans/exceptions as well as briefing packets for HAs- Supportive author for multiple abstracts and journal publications

South San Francisco, California, Us

Within the PDC I2O, tasked with pairing strategic work with effective operations and communications initiatives to deliver on functional business priorities. Assists in the planning and execution of PDC I2O functional projects and efforts, adopting project management best practices, executing consistently and with high quality to enhance long-term operational effectiveness. Partner with key stakeholders (e.g. PDMA, PSE, GPS, REDs, PDD, etc.) to enhance employee engagement and align on functional priorities and activities. Report into the Chief of Staff, PDC I2O & N •Engage in cross-functional initiatives that are integral to strategies•Development of communications efforts aiming to enhance employee engagement, awareness and understanding of our strategic priorities •Drive the rhythm of the business, business planning, business management, and team communications•Ensure effective management of the operational aspects, project management support for I2O business and community initiativesDesign, implement and optimize cross-functional processes and business practices to support efficiencies and effectivenessSupport design, development and execution of functional and cross-functional Town Halls, off-sites, F2F meetings and similar joint events with stakeholders Support efforts in cultivating an environment that makes a great place to work, nurture a collaborative community with strong sense of belongingRole model the Pharma Operating PrinciplesSelf-motivated, go-getter, curious, creative and excellent communicator ( written and verbal)Drive for results, communicate for actions, steward of the “big picture”Excellent teamwork, collaboration skills in a matrix environment and across organizational levelsLead cross-functional projects and deliver on promisesBuild and nurture positive and productive relationships Foster a great team cultureDrive multiple priorities, outstanding time management and planning skillsSimplify, bring order to chaos and focus

South San Francisco, California, Us

• Accountable leader within Operations managing small to large complex teams • Provide strong leadership and mentorship to enable and empowering cross functional team members • Develop strategy and garner support from key stakeholders to lead decision making for programs including prioritization of activities• Drive contributions at the strategic level including input into risk management plans, business value assessments and therapeutic area indication expertise• Global experience (NAM, EU, Asia Pac, China, Japan, LATAM etc.) in Ophthalmology and medical devices (Class I- III)• Accountable for people management in a global matrix environment• Mobilized teams to complete pivotal studies - strategic collaboration, motivation and empowerment to enable critical data readout, public presentations and timing of startup combined with implementation of novel tactics• Identified opportunities to leverage site relationships to support recruitment, retention and quality of data• Strategically implemented focus with Patient insights and education to support early immersion of key messages and lexicon• Developed the strategy and garnered support with internal leaders to create a new team with focused objective on surgical excellence within clinical trials using Surgical Device Liaison, Operations, Clinical Science, Technical and USMA/PDMA members• Leveraged external network to support enhancement of resources and skills needed to execute trial milestones• Actively involved in Agency and Regulatory meetings to support filing strategies, support globalization of trials, COVID-19 mitigations etc…• Implemented innovative tactics, tools and strategies to minimize COVID-19 disruption to ongoing recruiting studies as well as maintaining timelines for pivotal data and follow up snapshots – now being further developed for cross TA use• Strategically focused on building company reputation with physicians who were not familiar with Roche within this TA

South San Francisco, California, Us

South San Francisco, California, Us

● Focused on building and maintaining effective high performing teams with clear roles, responsibilities and accountability ● Chair and facilitate cross functional meetings and drive decisions to enable teams to meet deliverables and strategies implemented by Global Development Team and Life Cycle Team with Operations Program Leader (OPL)● Primary contact for key stakeholders such as OPL ● Responsible for setting and maintaining study team goals and milestones inclusive of timelines and resourcing plans to ensure success● Accountable and responsible for reporting and maintain progress within study budget with regular feedback to OPL and financial controllers, so that little variance is maintained between actuals and planned spend for accurate forecasting● Ensure that systems are current and updated as accordingly via Global Studies Managers (GSMs)/Global Studies Associates (GSAs)● Responsible for data collection and leading Study Management Team activities to ensure data is being cleaned on a regular frequency● Accountable for performance, issues and their resolutions of working with vendors and CROs to ensure studies are delivered as per scope of work, including any escalations as required● Responsible for quality, productivity and efficiency across the study inclusive of risk mitigation plans that could impact overall budget, quality and timelines of study● Provided GSM and GSA mentoring to ensure their success on the projects

South San Francisco, California, Us

South San Francisco, California, Us

● Provide expertise and leadership to other team members to ensure that the team has the tools to achieve results in support of clinical development plan● Responsible for feedback directly to the Operational Program Leader (OPL), and Global Studies Leader (GSL) based on monthly status reports from Vendors inclusion of risks, timeline impact and deliverables● Worked closely with Clinical Science and other function leads to develop key study documents and information for steering committees such as Protocol and ICF development and iDMC meetings● Developed strong relationship and leadership with co-collaborators for Global Phase III program inclusive of managing global CRO and third party CRO in Japan● Forecast, manage and track ~ $300 million study budget ● Led and contributed in the Request for Proposal (RFP) process, bid defenses, vendor selection and finalization of initial work orders and final work orders, inclusive of vendors such as CROs, IxRS, central labs and niche vendors● Responsible and accountable for CRO and overall performance, including their study plans and oversight of third party vendors such as Central Labs, Spirometry, Recruitment and Retention, ECG, ePRO, Meeting Planners, etc... ● Point person for study appointed Country Study Manger team across 30 + countries of the globe in North/South America, Europe, Middle East, Africa, Asia-Pacific● Manage global study feasibility & start up activates to ensure milestones such as submissions to IRBs, EC and MOH, activation and FPI met. Successfully met corporate goals and 4 out 4 LSPC goals● Responsible for vendor set up and performance ● Work closely with Pharma Technical Drug Supplies for management of device failures for auto injection syringes administered by subjects and pre-filled syringes ● Provide oversight for CRO planning/execution of face to face and Investigator meetings both US and ex-US● Provide oversight of study conduct to ensure compliance with ICH/GCP guidelines

South San Francisco, California, Us

Alameda, California, Us

● Managed study timelines and milestones such as submissions to IRBs, EC and MOH, activations, FPI, LPI, close out and clinical study reports (CSR) via proactively identifying issues and develop risk mitigation strategies.● Experienced in emerging countries such as Latin America and Asia as well as EU, Middle East and NAM ● Experienced in conducting site study start up activities, such as feasibility, IRB/EAC both local and central, training site personal via SIV and IMs● Experienced in authoring, facilitating and reviewing Informed Consent Forms (ICF) templates that are study specific, site specific (US) and Country specific (Ex-US) for initial submission, amendments and IB updates● Provided Clinical Operations feedback and input during development/amendments of protocols, radiology charters, PK and PD manuals, pharmacy manuals, safety management plans, data management plans, IDMC Meetings etc…● Authored and facilitated creation of various monitoring tools, monitoring plan, CRF guidelines and communication plans● Provided oversight of study conduct to ensure compliance with protocol, quality of data and ICH/GCP guidelines ● Developed and implemented risk mitigation plans to aid in completing enrollment via various recruitment tactics ● Contributed in the Request for Proposal (RFP) process during evaluation and selection of vendors by reviewing proposals and contracts, budget revisions and change orders● Facilitated and managed Clinical Working Groups that consisted of members from all functions in interdepartmental project meetings with follow up on action items● Reported back to Clinical filing team in preparation for NDA filing. Inclusive of ensuring the study timelines incorporated the clinical filing timelines to meet corporate deliverables and interim CSRs● Functioned as a vendor manager for the global Phase III study vendors such as: Imaging, ECG and central Labs.

Alameda, California, Us

Alameda, California, Us

Alameda, California, Us

● Collated, supported and presented at department and project meetings for program strategy development● Supported creation of Molecular Profiling Group (MP) within NLD● Developed assays targets using novel technologies to enhance data accuracy ● Designated expert for management and oversight of department robotic liquid handling systems ● Responsible and managed direct staff including appropriate training and performance evaluations for career growth

Alameda, California, Us

Kenilworth, New Jersey, Us

ASSISTANT SCIENTIST 2

New York, New York, Us

Worked in the GMP facilities updating company GMP and GLP SOPs and documentation

Pmp, Project Management

Bs, Biochemistry

Clinical Trials Design And Management