Senior Director, Clinical Development
Remote
Full Time
Senior Manager/Supervisor
Objective
The Senior Director, Clinical Development, will provide medical and scientific leadership for oncology clinical trials across pre-clinical through phase 1-4 development. This role requires strong expertise in oncology, radiopharmaceuticals, and clinical drug development to ensure patient safety, scientific rigor, and regulatory compliance across assigned programs.
The Senior Director will serve as a medical leader within cross-functional development teams, contributing to clinical strategy, protocol development, and regulatory interactions. This individual will play a critical role in advancing clinical programs toward regulatory approval and supporting future commercialization, while partnering closely with Clinical Operations, Regulatory Affairs, Safety, Translational and other teams as needed.
Essential Functions
Medical Strategy and Clinical Oversight- Provide medical leadership for assigned oncology clinical programs across pre-clinical through phase 1-4 development.
- Contribute to the development and execution of clinical and medical strategies aligned with program and company objectives.
- Oversee patient safety, therapeutic efficacy, and clinical trial data integrity, including identification and mitigation of clinical risks.
- Ensure compliance with Good Clinical Practice (GCP), ethical standards, and applicable regulatory requirements.
Medical Leadership and Scientific Expertise
- Serve as the primary medical expert for assigned studies, advising on protocol design, eligibility criteria, endpoints, and safety monitoring and study execution and management.
- Support regulatory interactions by providing medical input for health authority meetings, briefing documents, and responses to regulatory questions.
- Review and interpret clinical data to inform internal decision-making and external communications.
- Mentor and support medical monitors and clinical development team members, contributing to a collaborative and high-performing development environment.
Cross-Functional Collaboration
- Partner closely with Clinical Operations, Regulatory Affairs, Translational Medicine, Biostatistics, and CMC to support efficient trial execution.
- Contribute to the development, review, and approval of clinical protocols, informed consent forms, clinical study reports, and other key documents.
- Provide medical input to support dose selection, risk/benefit assessments, and lifecycle planning activities.
Regulatory and Corporate Contributions
- Support preparation and review of regulatory submissions, including INDs, amendments, clinical study reports, and safety documentation.
- Participate in health authority meetings and advisory boards as a medical representative for assigned programs.
- Asist in data interpretation, clinical presentations, and publications to support regulatory and scientific objectives.
Innovation and Industry Leadership
- Stay at the forefront of advancements in oncology, radiopharmaceuticals, and clinical development methodologies, integrating new scientific and technological innovations into the company’s clinical strategy.
- Build and maintain relationships with KOLs, academic institutions, and industry consortia to enhance scientific collaboration and drive innovation.
- Advocate for the company’s vision and therapeutic advancements, positioning the organization as a leader in oncology drug development.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education / Experience
- Medical Doctor (MD) degree from an accredited medical school required; Board certification in oncology strongly preferred.
- 5+ years of relevant industry experience, or an equivalent combination of industry experience, clinical practice, academic research, and demonstrated leadership in drug development.
- Demonstrated experience contributing to clinical development programs across one or more phases (Phase I–IV), preferably in oncology and/or radiopharmaceuticals.
- Proven ability to operate with increasing independence and accountability within cross-functional drug development teams.
- Experience participating in global regulatory interactions and contributing to clinical regulatory submissions.
Knowledge, Skills & Ability
- Strong working knowledge of Good Clinical Practice (GCP), FDA regulations, ICH guidelines, and global regulatory standards.
- Ability to apply clinical judgment and scientific rigor to complex development challenges.
- Excellent collaboration and communication skills, with the ability to engage effectively with both internal and external stakeholders.
- Strong analytical and problem-solving capabilities with a data-driven mindset.
- Proven ability to manage multiple complex programs and drive execution in a fast-paced, dynamic environment.
- Willingness to travel up to 30% of the time, including domestic and international travel as needed.
This role represents a pivotal opportunity for a strategic and visionary medical leader to shape the future of oncology drug development and drive transformational impact in cancer treatment.
Work Environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- May be required to sit or stand for long periods of 8+ hours a day while performing duties.
- Willingness to complete safety training within allotted timeframes, and work in a team-based environment.
Perspective Therapeutics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
For information on Perspective Therapeutics, visit our website at: www.perspectivetherapeutics.com.
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