itcss
Director, Early Development - Clinical Science
Irvine, California, United States · Director
Sponsorship not specified$203k-$285kDetected 53 days ago
RecruitingHRFDA RegulatoryResearchLeadershipCommunicationCollaborationProblem SolvingBiostatisticsRegulatory Affairs
About the role
- This individual will be accountable for leading the cross-functional Study Teams to meet study deliverables and represent clinical development in core team and investigator meetings as needed.
- Shape clinical plans including timelines, budgets and oversight of clinical teams.
- Engage with internal and external stakeholders, including KOLs and regulators.
Responsibilities
- Interpret clinical data and support data-driven decisions.
- Outcome Driven - Demonstrates strong outcomes focus by aligning teams around shared priorities, proactively addressing risks and dependencies, and driving cross-functional accountability to sustain progress and deliver results.
- Empowering Others - Fosters empowerment by aligning authority with accountability, developing leaders' decision-making capability, and creating systems that support performance and growth.
- Emotional Intelligence - Foster trust and psychological safety, navigating complex interpersonal dynamics with compassion and accountability, and adapting leadership style to support others while maintaining composure under pressure.
Requirements
- Some travel may be required - up to 30%
Nice to have
- Advanced degree in sciences (e.g. PharmD, MD, PhD) with deep experience in early clinical development
- Experience in ophthalmology is preferred
- dermatology or infectious diseases a plus.
- Minimum of 10 years of biotech/pharmaceutical clinical development experience, with a minimum of 8 years leadership in clinical trial management experience required
- Established leadership track record with evidence of excellent performance-based people management experience, problem solving, collaboration, cross functional leadership and effective communication skills.
- Expertise with SOPs, GCPs and regulatory and compliance guidelines for clinical trials.
- Must be willing to be "hands on" and delve into details
- Empowering Others
Skills
- Your Human Resources Team
Compensation
- The expected base pay range for this position is $203,200 - $284,600 plus bonus, stock equity, and comprehensive benefits.
Benefits
- Conduct research to develop foundational education material to inform the early development program strategies.
- Collaborate with Clinical Operations, Regulatory Affairs, Translational Sciences, Biostatistics, Medical Affairs and others to ensure robust trial design, scientific and operational alignment and execution.
- The position will be based in our beautiful Irvine office, complete with onsite gym, pool, snacks, drinks, and occasional catered meals.
Company info
- We are passionate about our culture! Our Tarsans live our values of commitment to patients, empowerment to champion innovation, and teamwork to amplify impact!
- We are passionate about our culture!
- Our Tarsans live our values of commitment to patients, empowerment to champion innovation, and teamwork to amplify impact!
This listing is sourced directly from itcss's careers page and normalized into a canonical job model.