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.
Requirements
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 handle complex projects to overcome delays and obstacles to meet deadlines.
Experience in leading scientific teams and providing mentorship.
Strong project and time management skills; ability to develop timelines and ensure deliverables are met within project scopes.
Willingness to travel domestically and internationally, approximately 10%, as required by project needs.