Actithera · 3 days ago
Global Clinical Development Head
United States
Full-time
Remote
Director/Executive
$250K/yr - $375K/yr
10+ years expActithera is a company focused on innovative therapies, and they are seeking a Global Clinical Development Head to oversee the clinical development strategy for their radiopharmaceutical ligand therapy asset. This role involves leading protocol design, managing key opinion leader engagement, and ensuring the asset's clinical success through strategic initiatives and collaboration with cross-functional teams.
BiotechnologyHealth CareLife ScienceMedicalTherapeutics
Responsibilities
Lead the development, review, and optimization of clinical trial protocols for the lead RLT asset, ensuring alignment with scientific objectives, regulatory requirements, and patient safety
Define and refine the TPP for the lead asset, integrating input from cross-functional teams (e.g., R&D, regulatory, commercial) to outline desired clinical outcomes, efficacy endpoints, safety profiles, and market positioning in the RLT landscape
Build and execute a comprehensive key opinion leader (KOL) engagement strategy, identifying global experts in RLT, oncology, and nuclear medicine
Oversee the creation, updates, and dissemination of the IB, ensuring it accurately reflects preclinical and clinical data, including RLT-specific risks like radiation exposure and long-term effects
Develop and maintain all scientific slides and materials for internal and external use, including investor presentations, regulatory meetings, and conferences
Collaborate with clinical operations, regulatory affairs, and overall R&D team to align on asset strategy
Identify and mitigate clinical risks associated with RLT, such as off-target radiation effects, and drive innovation in trial design (e.g., adaptive trials or biomarker-driven approaches)
Mentor junior clinical staff and contribute to talent development within the clinical organization
Qualification
Required
MD, PhD, or equivalent in a relevant field (e.g., oncology, nuclear medicine, or pharmacology); board certification in oncology preferred
10+ years of experience in clinical development within biotech or pharma, with at least 5 years in leadership roles focused on radiopharmaceuticals or targeted therapies
Proven track record in protocol design, TPP development, and KOL management for Phase I-III trials
Strong understanding of RLT principles, including radiochemistry, dosimetry, and regulatory pathways (e.g., FDA/EMA guidelines for radioactive drugs)
Excellent communication skills, with experience presenting to executive teams, regulators, and scientific audiences
Ability to thrive in a fast-paced, startup-like biotech environment with a collaborative mindset
Benefits
Eligibility for an annual bonus
Equity participation
Comprehensive benefits program
Company
Actithera
Actithera is a molecular radiotherapeutic company that develops radioligand therapies.
2-10 employees
Funding
Current Stage
Early StageTotal Funding
$75.5M2025-07-09Series A· $75.5M
Leadership Team
Andreas Goutopoulos
CEO and Founder
Darshan Dalal
Chief Medical Officer
Recent News
2025-12-04
Company data provided by crunchbase