Sr. Director, Clinical Development Oncology

Alentis Therapeutics

6d

About The Position

The Senior Director, Clinical Development provides medical leadership and strategic input across the company’s clinical development programs. Reporting to the Vice President, Clinical Development, the role contributes to the design, execution, monitoring, analysis, and reporting of clinical studies while ensuring scientific integrity, patient safety, and regulatory compliance. The position provides medical and scientific leadership for assigned oncology programs from early-stage development through late-stage trials; contributes to clinical development strategies, plans, target product profiles, and regulatory strategies; and evaluates emerging data to inform program decisions.

The role serves as Medical Monitor for clinical studies and contributes to protocol and clinical document development, study oversight, data review, safety assessments, regulatory submissions, and health-authority interactions. It also engages investigators, key opinion leaders, academic collaborators, clinical trial sites, and scientific audiences, while collaborating with Clinical Operations, Biostatistics, Data Management, Translational Medicine, Biomarker teams, Medical Affairs, and Business Development.

Requirements

• MD or equivalent medical degree, with advanced knowledge and clinical training in a medical or scientific area.
• Oncology clinical practice experience.
• At least 8 years of experience in clinical drug development in biotech, pharmaceutical, or academic settings.
• Experience serving as Medical Monitor in interventional clinical studies.
• Demonstrated involvement in the design and execution of Phase I–III clinical trials.
• Strong knowledge of GCP, ICH guidelines, and global regulatory requirements.
• Solid understanding of clinical trial methodology, statistics, and data interpretation.
• Experience in protocol development and clinical study reporting.
• Familiarity with pharmacovigilance and clinical safety processes.
• Valid US work authorization or US citizenship.

Nice To Haves

• Experience interacting with regulatory authorities.
• Prior experience in a small biotechnology company.

Responsibilities

• Contribute to the development and execution of clinical development strategies aligned with corporate objectives.
• Provide medical and scientific leadership for assigned clinical programs from early-stage development through late-stage clinical trials.
• Support preparation of Clinical Development Plans, Target Product Profiles, and regulatory strategies.
• Evaluate emerging scientific and clinical data to inform program decisions.
• Serve as Medical Monitor for clinical studies, ensuring patient safety and protocol compliance.
• Contribute to the design and review of clinical study protocols, investigator brochures, informed consent forms, and other clinical documents.
• Participate in study start-up, execution, oversight, and close-out activities.
• Review and interpret clinical study data and support data review meetings.
• Contribute to identifying and mitigating clinical risks.
• Review and assess serious adverse events and adverse events of special interest.
• Collaborate with Pharmacovigilance on safety monitoring and reporting.
• Participate in safety review committees and data monitoring activities.
• Support benefit-risk assessments throughout the development lifecycle.
• Contribute to regulatory submissions and interactions with global health authorities.
• Support preparation of briefing documents, clinical study reports, investigator brochures, and submission dossiers.
• Provide medical expertise during regulatory inspections and audits.
• Establish and maintain relationships with investigators, key opinion leaders, academic collaborators, and clinical trial sites.
• Represent the company at scientific meetings, investigator meetings, advisory boards, and industry conferences.
• Support publication planning and presentation of clinical data.
• Work with Clinical Operations to ensure efficient trial conduct.
• Collaborate with Biostatistics and Data Management on data analyses and interpretation.
• Partner with Translational Medicine and Biomarker teams to integrate scientific insights into clinical development.
• Provide medical input to Medical Affairs and Business Development activities as needed.

What This Job Offers

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