Ajay Bhasale

Senior Director, Data Management ✨

Transforming biopharmaceutical research through innovative data strategies and leadership in clinical data management.

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About Me 🤓

Profile Snapshot

  • Senior Director with 20+ years in
    Clinical Data Management
  • Based in San Mateo, CA
  • Bachelor of Engineering
    (Computer Science)
  • Relevant Certifications:
    - Machine Learning
    - CDISC (C-DASH, SDTM, ADaM, ODM)
    - Health Economics, Outcomes Research

Professional Summary

Seasoned pharmaceutical executive with extensive experience in clinical data management, analytics and programming within the biopharmaceutical industry. Proven track record of leading cross-functional teams to deliver high-quality data management solutions that accelerate drug development and ensure regulatory compliance.

My superpower? Making complex data concepts accessible to everyone from scientists to CEOs. I am passionate about data standards, process optimization, and mentoring the next generation of data professionals.

5+

Therapeutic Areas

(from A to Z)

75+

Clinical Trials

(and counting!)

30+

Team Members

(my data tribe)

20+

Recognitions

(shiny trophies)

My Professional Journey 🚀

From data newbie to data guru - here's how I leveled up in the pharma world

Senior Director, Data Management

2023 - 2024

CymaBay Therapeutics (Gilead Sciences), Fremont, CA

  • As Head of Clinical Data Management, I aligned internal teams and CRO collaborations to execute Phase I-III clinical trials for rare disease program, optimizing timelines and resource allocation. Streamlined execution of a pivotal Phase III trial through cross-functional coordination thereby significantly reducing time to database lock. Implemented a Business Intelligence analytics framework to expedite top-line results delivery. By refining risk-based monitoring metrics, successfully delivered key actionable insights on CRC, CRA, and CRO performance targeting high-data-burden sites. Finally, led functional deliverables for two regulatory inspections resulting in securing U.S. and EU approvals for Livdelzi.

Senior Director, Clinical Data Management

2018 - 2022

Arena Pharamceuticals (Pfizer), San Diego, CA

  • As Senior Director of Clinical Data Management, established and scaled a dedicated data management team from the ground up to support our inflammatory pain and cardiovascular portfolios. Authored and deployed functional SOPs and data specifications ensuring efficient, CDISC-compliant study execution across all trials. Developed and implemented a Business Intelligence analytics framework that embedded data-driven decisions into our daily workflow. Finally, by optimizing end-to-end processes, we drove meaningful efficiencies in database lock timelines.

Director, Clinical Data Management

2018 - 2018

Aquinox Pharamceuticals, San Bruno, CA

  • As Head of Clinical Data Management, I established data management function supporting our Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) program. By directing CRO operations, we maintained rigorous data quality and regulatory compliance while achieving on-time database locks for the pivotal clinical trial. To strengthen oversight, I established a monitoring framework using Business Intelligence that tracked site and CRO performance through actionable data insights.

Director, Clinical Data Management

2017 - 2018

Ionis Pharamceuticals, Carlsbad, CA

  • As Head of Clinical Data Management, I grew our data management team with a strategic mix of internal and external talent to advance rare disease development portfolios. By optimizing resourcing through strategic and focused insourcing and outsourcing, we accelerated delivery of data readouts for high-impact clinical development programs. This streamlined approach to data management across Phase I-III trials reduced data query volumes thereby freeing teams to focus on higher-value data priorities.

Program Director, Evidence Science and Innovation

2014 - 2017

Genentech Inc., South San Francisco, CA

  • As Program Director of Evidence Science and Innovation, I established the Design & Technology Lab (DTL), bringing together expertise in UX, Big Data, and Predictive Analytics. The team directed real-world data access shaping evidence strategies, addressing evidence gaps, and supporting clinical decisions. We built an unified platform to capture product evidence requirements thereby strengthening collaboration and data exchange with MCO partners.

Associate Director, Clinical Data Management and Programming

2010 - 2014

Roche | Genentech Inc., South San Francisco, CA

  • After the Roche-Genentech integration, I co-led the build-out of the clinical data management and programming function, structuring it from inception. My responsibilities included consolidating 25 studies across 10 clinical products into a unified operational framework ensuring zero disruption to the key portfolio objectives. Later, I spearheaded the design and launch of a digital engagement hub to inform clinical decisions through evidence based dialogue between HCPs and NSCLC patients at point-of-care.

My Data Superpowers 🦸‍♀️

The skills I have mastered to fight the forces of messy data and inefficient processes

Leadership

Building and mentoring high-performing global data management teams, fostering collaboration across functions, and creating a culture of continuous improvement and innovation.

Data Strategy

Developing comprehensive data strategies aligned with clinical development objectives, ensuring data quality, integrity, and regulatory compliance throughout the drug development lifecycle.

Regulatory Compliance

Ensuring adherence to FDA, EMA, ICH-GCP, and other regulatory requirements, with expertise in CDISC standards (C-DASH, SDTM, ADaM, ODM), 21 CFR Part 11, and data privacy regulations.

Therapeutic Expertise

Deep understanding of oncology, rare diseases, immunology, inflammatory pain, hepatology and cardiovascular therapeutics, with ability to tailor data strategies to specific therapeutic area requirements.

Process Optimization

Implementing lean methodologies and digital solutions to streamline clinical data processes, reduce cycle times, and improve operational efficiency without compromising quality.

Data Analytics

Leveraging advanced analytics, machine learning, gen AI, and visualization techniques to derive actionable insights from clinical trial data, supporting evidence-based decision making.

My Trophy Case 🏆

High-profile recognitions for my data wizardry over the years

Cymply The Best Awards (x 2)

CymaBay Therapeutics

Recognized for pioneering the implementation of a Business Intelligence framework for real-time clinical data quality monitoring, driving significant improvements in data accuracy and reducing time to top-line results, ultimately enhancing data-driven decision-making in clinical research.

#BusinessIntelligence #ClinicalDataQuality

Excellence in Leadership

Arena Pharmaceuticals

Acknowledged for leadership during the COVID-19 pandemic, establishing a decision framework to preserve eCOA (ePRO ClinRO) data integrity across three critical clinical programs, ensuring reliability, continuity, and scientific validity amid unprecedented challenges.

#Leadership #ClinicalDataIntegrity

NSCLC: gDATA Program

Genentech Inc.

Recognized for development and deployment of a responsive mobile/web platform integrating patient profile-based outcomes from nine pivotal NSCLC studies, accelerating evidence-driven HCP communication and optimizing access to critical clinical insights for informed decision-making.

#NSCLCResearch #HealthcareInnovation

ACE Innovator Awards (x 2)

Genentech Inc

Recognized for establishing the Design & Technology Lab in U.S. Medical Affairs, delivering two digital solutions through exceptional design and engineering. These innovations forged new MCO collaboration pathways, rapidly identifying evidence gaps to inform strategy for marketed drugs.

#DigitalHealthSolutions #MedicalInnovation

Let's Chat Data! 💬

Want to discuss how I can help with your data challenges? Drop me a message!

Ask away - I'm all ears (well, metaphorically)

Contact Information

I am always excited to connect with fellow data enthusiasts, potential collaborators, or anyone interested in advancing pharmaceutical data science.

Phone

(650) 477-0119

Location

San Mateo, California, USA