16 Aug
|
Pandorum Technologies
|
Bengaluru
16 Aug
Pandorum Technologies
Bengaluru
Mandate
- Design fidelity in the clinic
- Own investigator training on the tissue-state eligibility framework, the structural grading scales, and patient-reported outcome administration, across all participating sites and indications.
- Build and run the grading calibration and inter-rater reliability programme: reference materials, calibration rounds completed before first patient in, pre-specified reliability thresholds, periodic re-calibration, and ongoing drift monitoring.
- Own the adjudication pathway for discordant and borderline gradings.
- Maintain criteria-integrity surveillance: every eligibility decision documented against the framework, every borderline case and deviation escalated.
- Investigator, expert and institutional engagement
- Act as principal scientific relationship owner for UAE clinical partners and health-authority stakeholders.
- Sustain and deepen the established investigator relationships in India and Japan.
- Build the investigator network for the pre-planned second-stage indication.
- Evidence and publication strategy
- Own the publication plan for a study intended to be a landmark first-in-human result, and drive it to delivery.
- Set congress and scientific-communication strategy.
- Hold scientific-narrative consistency across every output — abstracts, posters, manuscripts, investigator materials, and health-authority correspondence.
- Regional medical and access foundation
- Support the epidemiology and market-access groundwork underway with regional partners.
- Build the medical foundation for eventual payer and reimbursement engagement across MENA.
Scope boundaries
These are stated up front, deliberately. This role does not own:
- Clinical operations — regulatory submissions, site contracting and initiation, monitoring, data management and vendor oversight sit with the CRO, under the CEO.
- Study design — the protocol, endpoints, eligibility criteria and statistical architecture are set and, in material part, filed as intellectual property. This role executes fidelity to the design; it does not redesign it.
- Intellectual property and regulatory strategy, which sit with the CEO and counsel.
- Financing and investor engagement.
Requirements
- Medical degree, with 10+ years in medical affairs and substantial depth in ophthalmology.
- Demonstrated ownership of multi-site, multi-investigator scientific standardisation or diagnostic-competency programmes — at scale, and with measurable outcomes.
- Regional medical strategy experience across emerging, Middle East or Asia-Pacific markets.
- A track record of building durable scientific relationships with academic and government institutions.
- Willingness to be present in the UAE as the programme requires — including sustained presence around site initiation, investigator calibration, and the first-patient-in period.
📌 Senior Director - Medical Affairs (Bengaluru)
🏢 Pandorum Technologies
📍 Bengaluru