Pandorum·1 month ago
1 month ago
Senior Director - Medical Affairs
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About this role
Job Description:
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.
• This position involves travel across the UAE, Bangalore, and Delhi.
Company
Pandorum
Bengaluru, India
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