Sr. Director, Clinical Development Oncology

Alentis Therapeutics; United States; Remote; USD 180,000 - 320,000; Full time

Job summary

Alentis Therapeutics is seeking a Senior Director, Clinical Development to provide medical leadership across development programs. You will influence trial design, safety oversight, data interpretation, and regulatory strategies, ensuring scientific integrity and patient safety.

You will collaborate with cross-functional teams, engage with investigators and KOLs, and contribute to global regulatory submissions and inspections as part of a small biotech environment in the United States.

Qualifications

• MD or equivalent medical degree with advanced clinical training.
• Minimum 8 years of experience in clinical drug development in biotech/pharma/academic settings.
• Experience serving as Medical Monitor in interventional studies.
• Involvement in Phase I-III trial design and execution.
• Familiarity with regulatory interactions and GCP/ICH guidelines.

Responsibilities

• Provide medical leadership across clinical development programs.
• Design, execution, monitoring, analysis and reporting of clinical studies.
• Lead safety oversight, SAE review and pharmacovigilance collaboration.
• Support regulatory submissions and interactions with health authorities.
• Engage with investigators, KOLs and trial sites; represent company at meetings.

Skills

Medical leadership

Clinical development

Study design

Safety management

Regulatory interactions

Cross-functional collaboration

Data interpretation

Education

MD or equivalent

Job description

About this position

The Senior Director, Clinical Development is responsible for providing medical leadership and strategic input across the clinical development programs of the company. Reporting to the Vice President, Clinical Development, the incumbent will contribute to the design, execution, monitoring, analysis, and reporting of clinical studies, ensuring scientific integrity, patient safety, and regulatory compliance.

Your tasks:

Clinical Development Strategy

• 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 the preparation of Clinical Development Plans, Target Product Profiles, and regulatory strategies.
• Evaluate emerging scientific and clinical data to inform program decisions.

Clinical Trial Design and Execution

• 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 the identification and mitigation of clinical risks.

Safety Oversight

• Review and assess serious adverse events (SAEs) and adverse events of special interest.
• Collaborate with Pharmacovigilance to ensure appropriate safety monitoring and reporting.
• Participate in safety review committees and data monitoring activities.
• Support benefit-risk assessments throughout the development lifecycle.

Regulatory and Scientific Support

• Contribute to regulatory submissions and interactions with global health authorities.
• Support the preparation of briefing documents, clinical study reports, investigator brochures, and submission dossiers.
• Provide medical expertise during regulatory inspections and audits.

External Stakeholder Engagement

• Establish and maintain productive relationships with investigators, key opinion leaders (KOLs), 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.

Cross-Functional Collaboration

• Work closely 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.

Role requirements

• MD or equivalent medical degree in addition to advanced knowledge and clinical training in medical/scientific area; Oncology clinical practice experience.
• Minimum 8 years of experience in clinical drug development within 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.
• Experience interacting with regulatory authorities is preferred.
• Prior experience in a small biotechnology company is advantageous.
• 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.

Work permit

Candidates must hold valid US work authorization or be US citizens.