Sr. Manager or Associate Director, CRP (Oncology)

TL;DR

Sr. Manager or Associate Director, CRP (Oncology): Managing the planning, execution, and monitoring of global and regional oncology clinical trials with an accent on medical expertise and regulatory compliance. Focus on designing clinical trials, interpreting clinical trial data, and serving as the lead medical representative with regulatory agencies.

Location: Shanghai, China

Company

hirify.global is a biopharmaceutical company tackling unmet needs in oncology by developing differentiated and novel therapeutic candidates.

What you will do

• Lead the planning, execution, management, and monitoring of global and regional oncology trials.
• Support the drafting of core product profiles and clinical development plans.
• Provide medical direction for clinical trial design and interpret trial data for scientific conclusions and manuscripts.
• Write and review study-related documents including protocols, investigator brochures, and safety management plans.
• Act as a medical monitor and lead representative for communications with regulatory agencies.
• Collaborate with cross-functional teams to ensure trials meet key milestones and budgets.

Requirements

• MD and PhD preferred with specialized medical expertise in oncology.
• Over 3 years of experience in an R&D physician role within a pharmaceutical company.
• Proven experience in oncology projects, particularly with solid tumors in later-stage projects.
• Deep understanding of the strategic and operational aspects of clinical research and product development.
• Strong knowledge of GCP, FDA, and EMEA/CHMP regulations and guidelines.
• English: Strong communication skills required.

Culture & Benefits

• Competitive base salary, performance-based annual bonuses, and equity plans.
• Generous leave policy with up to 15 OPT and 12 sick days annually.
• Comprehensive medical coverage.
• Social Security and Provident Fund.
• Collaborative work environment emphasizing integrity, results, and accountability.