Associate Director, Clinical Sciences, Oncology

Responsibilities

• Contribute to the development and execution of clinical trial strategies and other study-related materials (e.g. case report forms, operational plans) and provide clinical representation for study-related review committees (e.g., protocol review committee).
• Contribute to the execution of clinical strategies for clinical trial protocols, ensuring compliance with scientific, organizational and regulatory standards.
• Oversee end-to-end delivery of a clinical trial protocol, including study design, initiation, medical data monitoring, data dissemination, and closeout activities.
• Contribute to the management and coordination of activities with internal functional partners and external partners to ensure timely scientific and clinical execution of a clinical trial.
• Contributes to the maintenance of the quality and integrity of clinical data, which is critical to the evaluation of study endpoints.
• Support interaction and collaboration with investigators and study teams during the conduct of the trial(s).
• Lead training on study protocol, disease evaluation criteria, and other essential components to enhance the understanding of clinical development processes.
• Contribute to the review, interpretation, and reporting of clinical trial data, supporting accuracy and integrity for health authority submissions.
• Contribute to the preparation of documents for reporting clinical trial data (e.g., clinical study reports, patient narratives, investigator brochures, and periodic safety updates).
• Collaborate with Study Responsible Scientist and Study Responsible Physician to assess and evaluate clinical trial data (i.e. adverse events, labs, medications, etc).
• Establish and define medical data review plan in partnership with Study Responsible Physician.
• Performs medical data monitoring/reporting and evaluates ongoing clinical trial data.
• In partnership with Study Responsible Physician, act as a liaison between the company and clinical investigators, fostering collaborations with key opinion leaders and external advisors.
• Develop and maintain relationships with internal and external stakeholders, including senior management, cross-functional trial teams, and external partners/vendors (e.g. CRO, ARO).
• Contribute to mentorship and training of junior team members, fostering a collaborative work environment.
• Actively engage in opportunities to enhance clinical development and therapeutic area expertise.
• Identify opportunities for process improvements and implement best practices in clinical trial execution.
• Drive innovative research methods and operational strategies to enhance clinical development efficiency.
• Collaborate with cross-functional partners to align clinical strategies with overall product development goals.
• May participate in governance meetings, as appropriate, and cross-functional initiatives to promote business strategies and process improvements.
• Prepare and present findings and results of clinical research at internal and external meetings, including regulatory body interactions.
• May act as an author on scientific publications, as applicable, to contribute to clinical development practices and advancements.
• Research and review medical literature and new technologies to support operational planning and scientific strategy implementation.
• Integrate scientific and technological innovations into clinical trial designs, including biomarkers and digital health initiatives.

• A minimum of a bachelor’s degree in a scientific or related discipline is required.
• An advanced degree (e.g., MS, PharmD, PhD) is preferred.
• 6 years of relevant experience in clinical research and development within the pharmaceutical industry, biotech, CRO or equivalent is preferred.
• Prostate cancer and or solid tumor experience preferred.
• Strong understanding of clinical development processes, including trial design, protocol development, data analysis, regulatory guidelines, Good Clinical Practice (ICH/GCP), and study execution.
• Demonstrated experience in managing critical aspects of clinical trials, from conception to closure, including data management and quality assurance practices.
• Proven ability to interpret scientific literature and apply findings strategically within clinical projects.
• Proficiency in Microsoft Office Suite, especially Excel, Word, and PowerPoint, and familiarity with generative artificial intelligence and clinical trial management software are advantageous.
• Excellent written and verbal communication skills in English; ability to effectively present information to the stakeholders.
• Strong interpersonal skills with a collaborative approach to working within cross-functional and global matrix teams.
• Excellent organizational skills, ability to manage multiple tasks, prioritize effectively, and respond to changing business needs in a dynamic environment.
• Proven analytical and problem-solving capabilities, with a detail-oriented mindset.
• Ability to proactively identify program level issues/discussions that require escalation.
• Ability to…