Senior Director Clinical Development
Overview
Lead clinical study portfolio and drive diagnostic product development for cancer detection. Oversee strategy execution and collaborate with cross-functional teams to advance product claims and reimbursement.
What You'll Do11
- 1Develop and execute clinical studies generating robust evidence for product claims
- 2Advance diagnostic product development for cancer detection
- 3Implement five-year clinical development strategy aligned with scientific evidence
- 4Manage clinical development and operations groups along with CROs and investigators
- 5Partner with R&D Biostatistics to design and analyze clinical studies
- 6Direct clinical trial timelines budgets and risks in line with product development processes
- 7Interact with FDA on IVD product approval submissions and document preparation
- 8Collaborate with Medical Affairs to identify evidence gaps and gather real-world data
- 9Work with Data Engineering to store and curate clinical data
- 10Participate in industry stakeholder groups and present findings to senior leadership
- 11Drive start-up mindset with proactive decision-making and cross-functional teamwork
Requirements8
- 1PhD in physical or natural sciences or MD degree
- 2Expertise in cancer biology strongly preferred
- 38+ years leading clinical studies for pharma or diagnostics with strong publication record
- 43-5 years experience in IVD diagnostics development
- 5Knowledge of clinical regulatory standards ICH E6(R3) GCP ISO 14155 ISO 13485 21 CFR Part 820
- 66-8 years management experience including recruitment coaching and performance management
- 7Excellent communication skills in written and oral presentations
- 8Familiarity with AI approaches in clinical trials and international data standards
Salary Insight
Salary not disclosed in listing
Location
Required Skills
Similar open positions
Explore active roles that match your skills and interests.
Globalchannelmanagement
VerifiedClinical Development Trial Lead Associate Director
Drive successful clinical trial outcomes leading large-scale studies across multiple regions. Own end-to-end trial execution while fostering collaboration among diverse teams. Shape strategic direction influencing regulatory and operational frameworks.
AbbVie
VerifiedSenior Medical Director Oncology Clinical Development Solid Tumors
Lead and direct clinical development programs for solid tumors therapies. Oversee study design execution and interpretation of clinical data. Ensure regulatory compliance and drive scientific strategy. Collaborate with cross-functional teams to achieve therapeutic goals.
4314 AstraZeneca Pharmaceuticals LP Company
VerifiedExecutive Director Clinical Operations, Early Oncology
You lead the Executive Director, Clinical Operations role for Early Oncology, driving global clinical delivery and strategy for a significant portfolio. You own the execution and compliance, integrating AI and digital innovations to redefine trial operations. Oversee a team of 8-10 Sr. Directors and 15-20 Study Leaders, driving operational excellence and regulatory compliance. This role shapes industry standards in speed, quality, and patient engagement.
AbbVie
VerifiedSenior Medical Director Oncology Early Development AbbVie
Lead clinical development programs for oncology therapeutic area focusing on scientific and business strategy. Oversee study enrollment timelines and safety efficacy assessments. Provide in-house clinical expertise for molecules and diseases. Contribute to translational strategies and asset development initiatives.
US01 Illumina, Inc.
VerifiedDirector Product Management Integrated Clinical Solutions
Illumina seeks a Director Product Management leader to define and drive cohesive product strategy for an integrated clinical solution. This senior leader sets vision and evolves roadmap for instrumentation software and assay content. The role involves leading a team of product managers and influencing cross-functional stakeholders.
Treeline Biosciences
VerifiedRegulatory Affairs Director, Oncology Clinical Development
You will own global regulatory strategy and submissions for our oncology pipeline, driving INDs, NDAs, and BLAs through FDA and EMA approvals. Reporting to the VP of Regulatory Affairs, you will lead cross-functional teams across Clinical, CMC, and Pharmacovigilance to ensure compliance and speed. This role suits a hands-on strategist eager to shape regulatory precedent in a small, nimble biotech. You will directly influence agency interactions and regulatory policy, making a tangible impact on patient access.