Confidential mandate
Interim Chief Data and Analytics Officer — Pharma Evidence
Urgent / Replacement
A failed regulatory data inspection and executive departure require interim leadership to repair clinical-commercial lineage, govern analytics use and establish a trusted enterprise data office.
The mandate
A regulatory inspection could not reproduce selected clinical-safety and medical-information data transformations, and the data executive departed after incomplete lineage was confirmed. Commercial analytics also use related master data, creating an urgent need to separate regulated evidence from exploratory reuse without fragmenting ownership.
The interim must begin within three weeks for twelve months, covering inspection response, lineage repair and two controlled release cycles. Permanent recruitment begins after the enterprise data-accountability model is approved, with extension possible for six weeks if inspection closure or successor notice moves.
Handover is complete when cited regulated datasets have field-level lineage and validated controls, high-risk master-data defects are closed, analytics use is classified and approved, the inspection response is accepted, and the successor chairs one regulated data release.
The interim may quarantine data, set standards, redirect the approved ₹13 crore repair budget and appoint temporary stewards. Changes to regulated retention, new secondary use of sensitive data, permanent executive hiring, cloud commitments above ₹20 crore and risk acceptance for critical lineage gaps require committee or board approval.
Drug development decisions, biostatistical interpretation and commercial targeting strategy are outside scope. The data office guarantees evidence and permissible use, while accountable scientific and commercial leaders retain domain judgement.
Why this seat is open
The inspection invalidated claims that platform metadata alone constituted usable lineage. Internal leads own either regulated pipelines or commercial consumption and cannot neutrally settle the boundary. A temporary CDAO can restore reproducibility before long-term data strategy resumes.
What you will own
- Define critical data elements for clinical safety, medical information and associated regulatory submissions.
- Map field-level lineage from source capture through transformation, review, release and retained evidence.
- Decide which datasets are quarantined, corrected, revalidated or retired based on patient and regulatory consequence.
- Establish master-data ownership and quality rules across product, site, study, investigator and healthcare-professional domains.
- Approve analytics use through purpose, provenance, access, validation and accountable domain review.
- Close the inspection response with reproducible samples and sustained control evidence.
- Transfer lineage maps, data decisions, accepted uses, unresolved defects and the next release calendar to the successor.
Candidate qualifications
- Held CDAO, data governance chief or regulated-data director authority in pharmaceuticals, biotech or life sciences.
- Repaired clinical, safety or regulatory data lineage after inspection or audit challenge.
- Led validated data engineering and governance across scientific and commercial domains.
- Established master-data ownership where multiple regulated functions depended on shared entities.
- Made quarantine and secondary-use decisions involving sensitive health or research data.
- Can present technical lineage and validation evidence to inspectors and board committees.
Non-negotiables
- Available in Hyderabad within three weeks.
- No current role with the inspection-response consultancy or data-platform vendor.
- Will not permit exploratory analytics to alter regulated source evidence.
- Must have personally defended regulated data lineage during an inspection or audit.
- 49 words maximum. Confirm availability and disclose any life-sciences vendor conflict.
- 49 words maximum. Describe a regulated data transformation you made reproducible and the retained artefact.
- 49 words maximum. Which condition requires quarantining a shared clinical-commercial dataset?
This mandate is confidential. The client is named only under a mutual NDA, and your own record is never listed, sold or shown to a company under your name until you release it for this specific mandate.