David Zhang Email & Phone Number

Paris, Île-de-France, FR

South San Francisco, California, US

• As a founding member of the executive management team, took on a range of responsibilities to set the foundation of the company to grow from a start-up with 3 employees to a phase 3 ready enterprise today.
• Served as Chief Information Officer during early days of the company founding to establish initial capabilities in Biometrics, Data Management, IT, Facilities, and Investor Relations.
• Built up and grew Biometrics and Data Management team from ground up, as well as the cloud based GCP-compliant, submission-ready Biometrics Computing Environment.
• Successfully executed topline readout and ongoing data snapshots for the psoriasis phase 2 and open label extension studies to enable decision making and fundraising to support the phase 3 development on multiple.
• Established and organize Alumis Senior Leaders Group (ASLG) to ensure effective communications and alignment between senior leaders and the rest of the company as the company scales to the next phase of its.

As the Chair the 2021 BBSW Annual Conference Organizing Committee, I led a group of highly passionate and talented leaders and professionals to successfully conduct one of the first in-person conferences to help advance statistical and data sciences, expand our leadership presence and establish meaningful connections.https://www.bbsw.org/bbsw2021

Lawrence Township, NJ, US

Brisbane, California, US

• Build and lead advanced analytics capabilities to generate insights through integrating data from clinical trials and digital health to support MyoKardia's mission of developing and commercializing targeted.
• Oversee the expansion of Biometrics group to deliver pipeline projects and set solid foundation for the pivotal trial data readout and regulatory filings with in-house capabilities
• Spearhead the digital health effort across clinical development programs by incorporating wearable devices in clinical trials to enhance patient-centric data collection
• Build data science capability to better understand relationship between patient generated wearable data, PRO data, biomarker data and clinical trial data in an effort to have an integrated view of study results
• Serve on the R&D Data Warehouse Steering Committee to set out strategy and guide team on building the integrated data warehouse and analytics platform across MyoKardia.

Brisbane, California, US

• Build and lead Biometrics group to support company's mission of pioneering a precision medicine approach to discover, develop and commercialize targeted therapies for the treatment of serious and neglected rare.
• Recruited top talents to build the Biometrics group from ground up to support all development programs in the pipeline
• Established first GCP compliant Biometrics Computing Environment to enable robust in-house data analytics and NDA filings
• Played key role in crafting a novel primary endpoint for phase 3 pivotal study in obstructed hypertrophic cardiomyopathy (oHCM) to meet the unique needs of this patient population

Switzerland 🇨🇭, CH

• Reported to Chief Medical Officer as a core member of Medical Science and Affairs Leadership Team. Led biomarker and clinical data analysis to advance the development and launch of first next-generation-sequencing.
• Founded Biometrics and Data Science organization through strategic hiring and mentoring team members, creating data management and computing infrastructures, securing internal and external resources, and instituting.
• Led cross-functional analytics team in establishing medical values of NGS products through advanced data analytics and machine learning to fundamentally understand the linkage between somatic mutations and human.
• Spearheaded and managed pilots to introduce new technology by working with emerging analytics platforms such as Medidata CTG to enhance analysis of genomics data.

Fremont, CA, US

• Built and led sustainable biometrics functions to support lifecycle of product development for an innovative medical device using micro-needle technologies to increase speed, convenience, and efficiency of drug delivery.
• Performed speedy statistical analysis for driving critical pipeline decisions based on clinical trial data.
• Provided consultation on experiment and product design to clinical, CMC, research and manufacturing departments.
• Produced high-quality deliverables on time and on budget by identifying, negotiating, and managing CRO vendors.
• Partnered with Business Development and Packaging Design teams in deriving insights with data-driven approach.

Switzerland 🇨🇭, CH

• Built partnerships with external organizations to create tangible solutions that drove innovation in drug development.
• Led engineering initiative to forge strategic partnerships with internal and external innovators (GoogleX, Walgreen), transforming the drug development process through patient‐centric approach.
• Built and managed a 50‐member Global Innovation Advisory Board to co‐create visions for sustainable innovations with cross‐industry experts and internal executives and establish a network of 100 leaders connected with.
• Served as key member of Innovation Management Leadership Team catalyzing innovations, guiding 50% of molecule teams to adopt new tools in one year by applying design‐thinking methodology.
• Led clinical trials optimization in drug development by facilitating Roche’s participation in industry‐wide consortia (TransCelerate, Innovative Medicines Initiative, Clinical Trial Transformation Initiative).

Switzerland 🇨🇭, CH

• Drove rapid adoption of innovative tools and systems to solve the challenges.
• Launched an innovative tool to gather external physician insights on trial design and feasibility in over 30 teams, increased speed to market by saving time (over 3 months) and over $2M annually with broader inputs.
• Partnered extensively with Product Development (PD) business and functional leaders to identify and address unmet business needs, driving mindset shift for accessing external innovations.
• Delivered 10 Open Innovation experiments by working with PD teams and managing relationship with Open Innovation platform vendors, being recognized with Collaborative Innovation Excellence Award from Nine Sigma, Inc.
• Led a global cross‐functional team in the Innovation Hub and built an Open Innovation infrastructure to access innovations from outside the company and industry.

South San Francisco, California, US

• Managed high performing biostatistics teams and led molecule development in pivotal stages. Provided technical and strategic input to Genentech Research and Early Development (gRED) molecule teams across broad range of.
• Played key role in designing the pivotal trial using a novel approach and defended trial outcome in front of FDA, resulting in fast approval (without Advisory Committee) and successful launch of a drug for a difficult.
• Headed the cross‐functional Biometrics Submission Team and Development Filing Team for two BLA filings, securing timely FDA approval and market launch.
• Led statistical discussions in numerous key regulatory interactions with FDA and European Regulatory Agencies (EMEA, MHRA, Danish HA, Netherland HA) to enable INDs, EOP2 discussions and BLA filings.
• Served on the Task Force Experts Panel to define lupus endpoints by working with FDA and advocacy groups for lupus drug development, achieving FDA approval of 1st lupus drug in 50 years.
• Recognized as an award‐winning manager in Roche Global Biometrics for effective team mentorship.

South San Francisco, California, US

• Provided technical and biometrics leadership in multiple mission critical development programs.
• Headed Design, Analysis, Technology and Administration (DATA) Team in supporting development of anti CD20 Multiple Sclerosis treatment, resulting in groundbreaking effectiveness of new therapy, Ocrevus.
• Chaired the BILAG Subcommittee to ensure the understanding, training and implementation of this lupus assessment instrument was optimized across the novel lupus trials.
• Identified and brought on board a new Data Coordinating Center to scale up the DMC activities.
• Created the Rituximab Data Monitoring Committees and collaborated with Data Coordinating Centers in conducting ongoing DMC reviews, resulting in early stopping of lupus trials.
• Negotiated and resolved various technical issues with multiple developmental partners through collaborations.

Indianapolis, Indiana, US

• Provided leadership in study design, statistical analysis and result reporting of clinical trials in generalized anxiety disorder, epilepsy, Alzheimer and diabetic neuropathy.
• Provided expert input and statistical rationale during direct regulatory interactions with FDA in the US and KIKO in Japan.
• Formulated a proposal to convince FDA accepting diabetic neuropathy registration strategy with 1 successful trial and supportive data from 2 studies from similar indication.
• Participated in the preparation of NDA filing of PKC-beta Inhibitor for Diabetic Retinopathy. Responsible for the compilation of Clinical Summary of Safety reports.

North Chicago, Illinois, US

• Provided statistical leadership in study design and statistical analysis of Phase III/IV clinical trials for new drug development in neuroscience.
• Initiated the "Teacher's Forum" where local high school math/science teachers came to learn about how statistics is applied in the workplaces.

New York, NY, US

• Supervised a staff of 5 research associates during the data collection and data management process for trials conducted at the Anxiety Genetic Family Study and performed extensive data analysis and published results.
• Participated in the development of new statistical methodologies applied in genetic psychiatric research.

Ph.D., Biostatistics

Master Of Business Administration (M.B.A.), Finance

Master'S Degree, Statistics