Global Clinical Development Head

Actithera • Cambridge, MA

10d • $250,000 - $375,000 • Remote

About The Position

The Global Clinical Head, Lead Asset is a senior leadership role responsible for overseeing the clinical development strategy and execution for the company's flagship radiopharmaceutical ligand therapy (RLT) asset. This position plays a pivotal role in advancing innovative therapies from early-stage development through regulatory approval and commercialization. Reporting to the Chief Medical Officer or Head of Clinical Development, the incumbent will drive scientific and strategic initiatives to ensure the asset's clinical success, focusing on protocol design, target product profiles, key opinion leader engagement, investigator brochures, and scientific presentations. This role requires deep expertise in oncology or related fields, with a strong emphasis on radiopharmaceuticals, to navigate the unique challenges of RLT, such as radiation dosimetry, targeted delivery, and safety profiling.

Requirements

• 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.

Responsibilities

• Protocol Ownership: 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. Incorporate RLT-specific considerations, including radionuclide selection, biodistribution studies, and therapeutic index optimization.
• Target Product Profile (TPP) Management: 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.
• KOL Strategy Development: Build and execute a comprehensive key opinion leader (KOL) engagement strategy, identifying global experts in RLT, oncology, and nuclear medicine. Foster relationships through advisory boards, scientific collaborations, and presentations to gather insights and advocate for the asset's value.
• Investigator Brochure (IB) Oversight: 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.
• Scientific Slides and Presentations: Develop and maintain all scientific slides and materials for internal and external use, including investor presentations, regulatory meetings, and conferences. Ensure content is data-driven, visually compelling, and highlights the innovative aspects of RLT therapies.
• Cross-Functional Leadership: Collaborate with clinical operations, regulatory affairs, and overall R&D team to align on asset strategy. Provide clinical input into IND/CTA submissions and contribute to publication strategies.
• Risk Management and Innovation: 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).
• Team Leadership: Mentor junior clinical staff and contribute to talent development within the clinical organization.

Benefits

• Actithera offers a competitive compensation package designed to reward both performance and expertise through market-based, results-driven pay.
• For this role, the anticipated base salary range is $250,000 – $375,000, complemented by eligibility for an annual bonus, equity participation, and a comprehensive benefits program.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: Ph.D. or professional degree