Senior Director, Pediatric Translational Medicine

Planet Pharma; California; Hybrid; USD 246,000 - 332,000; Full time

Job summary

Planet Pharma seeks an Executive Director, Translational Medicine and Pediatric Planning to lead integrated pediatric development strategy across the portfolio. This role links disease biology, nonclinical findings, biomarkers, and clinical data to decisions on indication selection, dose, and progression.

The position involves developing PSPs/PIPs, waivers, deferrals, and regulatory commitments, with strong leadership in a matrixed organization. Domestic and international travel expected.

Qualifications

• Advanced degree in medicine, pharmaceutical sciences, pharmacology, immunology, translational science.
• 12+ years of relevant experience in clinical research or drug development.
• 5+ years leading cross-functional clinical-development, translational, or pediatric strategy.
• Experience developing PSPs, PIPs, waivers, deferrals, and health-authority interactions.
• Experience in regulatory submissions and post-marketing commitments.

Responsibilities

• Lead portfolio-level pediatric development strategy from candidate transition through registration and lifecycle management.
• Develop and execute pediatric plans across indications and therapeutic areas, including PSPs and PIPs.
• Create integrated translational strategies linking biology, biomarkers, and endpoints to decisions.
• Evaluate adult, adolescent, pediatric, nonclinical, and real-world evidence for extrapolation opportunities.
• Partner with Clinical Pharmacology to establish pediatric starting doses and dose-escalation approaches.
• Address age-appropriate formulations and administration with CMC and device teams.
• Lead pediatric study design, endpoints, eligibility criteria, and enrollment strategy.
• Own regulatory deliverables and support meetings with FDA, EMA, and other authorities.
• Maintain portfolio visibility of pediatric obligations and mitigate risks.
• Provide recommendations on pediatric opportunity and regulatory requirements.

Skills

Cross-functional leadership

Pediatric development knowledge

Regulatory strategy

Data-driven decision making

Education

Advanced degree (MD/PhD)

12+ years in biotech/pharma

5+ years pediatric strategy

PSPs & PIPs experience

Regulatory submissions experience

Job description

Planet Pharma seeks an Executive Director, Translational Medicine and Pediatric Planning to lead integrated pediatric development strategy across the portfolio. This role links disease biology, nonclinical findings, biomarkers, and clinical data to decisions on indication selection, dose, and progression.

The position involves developing PSPs/PIPs, waivers, deferrals, and regulatory commitments, with strong leadership in a matrixed organization. Domestic and international travel expected.