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.
Oncology 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 all aspects of clinical trials, from conception to closure, including data management and quality assurance practices.
Proven the 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.

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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills

clinical trial protocolsstudy designdata analysisregulatory guidelinesGood Clinical Practice (ICH/GCP)data managementquality assurance practicesmedical data monitoringclinical researchoncology experience

Soft skills

written communicationverbal communicationinterpersonal skillsorganizational skillsanalytical skillsproblem-solving skillsproject managementmentorshipcollaborationadaptability