PandorumActive opening

Senior Director - Medical Affairs

Bangalore · DelhiDirectorFound 27 days ago
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investigator trainingclinical study managementregulatory affairspublication strategymedical affairssite managementpatient-reported outcomesstakeholder engagement

Job Description:

Mandate

  1. 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.

  1. 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.

  1. 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.

  1. 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.

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PandorumSenior Director - Medical Affairs
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