Director, Clinical Sciences – Oncology

Role Overview

• Drive clinical development strategy, contribute to the development of other study-related materials (e.g. ADP, SAP, CSR outputs, case report forms, operational plans) and provide clinical representation for study-related review committees (e.g., first in human committee, protocol review committee).
• Lead the execution of clinical trial protocols within the clinical development program, ensuring compliance with scientific, organizational, and regulatory standards.
• Oversee end-to-end delivery of clinical trial protocols/programs, including study design, initiation, medical safety data monitoring, data dissemination, and closeout activities.
• Manage and coordinate activities with internal functional partners and external partners to ensure timely scientific and clinical execution of clinical studies.
• Maintain the quality and integrity of clinical data critical to the evaluation of study endpoints. Interact and collaborate 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.
• Review, interpret, and report clinical trial data, ensuring accuracy and integrity for health authority submissions.
• Draft 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 medical/safety data (i.e. adverse events, labs, medications, etc.). Establish and define medical data review plan in partnership with Study Responsible Physician. Leads and 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 credible relationships with internal and external stakeholders, including senior management, cross-functional trial teams, and external partners/vendors (e.g. CRO, ARO).
• Provide mentorship and training to junior team members, fostering a collaborative work environment.
• Guide and support colleagues in clinical development processes and standards.
• Identify opportunities for process improvements and drive the implementation of 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.
• 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 and academic partners.
• May act as an author for scientific publications, as applicable, to influence 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.
• Requires 10 years of relevant experience in clinical research and development within the pharmaceutical industry, biotech, CRO, or equivalent.
• Knowledge and experience in solid tumor cancers specifically prostate cancer is 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 all 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 is advantageous.
• Excellent written and verbal communication skills in English; ability to effectively present information and negotiate with stakeholders.
• Excellent interpersonal skills with a collaborative approach to working within cross-functional and global matrix teams.
• Exceptional 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 leading scientific teams, providing mentorship, and managing direct or indirect reports.
• 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.
• A commitment to maintaining high ethical standards and fostering a culture of inclusivity in the workplace.

Tech Stack

• Google Cloud Platform

Benefits

• Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in the Company’s long-term incentive program.
• Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
• Vacation –120 hours per calendar year
• Sick time
• 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time
• up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year