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 15+ 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

  • Managed internal teams and CRO collaborations, ensuring efficient Phase I-III trial operations for a rare disease portfolio.
  • Optimized pivotal phase III trial execution, reducing database lock time by 40% via cross-functional efficiencies.
  • Developed Business Intelligence framework for a 35% faster top-line results.
  • Optimized risk-based monitoring by delivering key insights on CRC, CRA, and CRO performance.
  • Led two successful regulatory inspections, securing U.S. and EU marketing approvals for Livdelzi.

Senior Director, Clinical Data Management

2018 - 2022

Arena Pharamceuticals (Pfizer), San Diego, CA

  • Established and scaled a high-performing data management team for inflammatory pain and cardiovascular portfolios.
  • Authored & deployed SOPs and data standards, streamlining CDISC-compliant study execution.
  • Pioneered BI analytics framework, enabling routine data driven-decisions.
  • Optimized processes to accelerate database lock timelines by 30%.
  • Key contributor to COVID-19 vaccine trial data strategy.

Director, Clinical Data Management

2018 - 2018

Aquinox Pharamceuticals, San Bruno, CA

  • Established a high-performing data management department supporting interstitial cystitis/bladder pain syndrome program.
  • Directed CRO operations to maintain data quality, meet regulatory standards, and achieve timely database lock in a pivotal phase III study.
  • Established data-driven monitoring for Site and CRO performance using Business Intelligence.

Director, Clinical Data Management

2017 - 2018

Ionis Pharamceuticals, Carlsbad, CA

  • Expanded data management team to 12 members, including contractors, advancing rare disease development portfolios.
  • Optimized resourcing through strategic insourcing and outsourcing, accelerating topline outcomes.
  • Streamlined data management across 25+ phase I-III clinical trials, achieving a 15% drop in query rates.

Program Director, Evidence Science and Innovation

2014 - 2017

Genentech Inc., South San Francisco, CA

  • Established the Design and Technology Lab (DTL), assembling a specialized team in UX, Big Data, and Predictive Analytics.
  • Directed real-world data access initiatives, optimizing evidence availability for HCPs at point-of-care.
  • Established a technology-driven solution for capturing product evidence and optimizing MCO collaboration.

Associate Director, Clinical Data Management and Programming

2010 - 2014

Roche | Genentech Inc., South San Francisco, CA

  • Developed and structured clinical data management and programming function after Roche-Genentech integration.
  • Led integration of 25 studies across 10 clinical products post-merger, ensuring seamless transition.
  • Developed and delivered a scalable digital solution to optimize HCP engagement in NSCLC.

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!

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