Director of Clinical Program Management (Autoimmune)
Full-time
Newave Pharmaceutical Inc,
Company Description Newave Pharmaceutical Inc. is a biopharmaceutical company focused on advancing innovative therapies in autoimmune and related disease areas. The organization emphasizes rigorous science, patient-centered development, and collaboration with clinical experts to bring new treatment options to market. Team members work in a dynamic, mission-driven environment that supports cross-functional collaboration and continuous learning. The company values integrity, inclusion, and accountability in all aspects of its operations, from research through commercialization.
Role Description The Director of Clinical Program Management (Autoimmune) is a full-time remote role responsible for leading end-to-end planning and execution of clinical programs in autoimmune indications. This role oversees cross-functional program timelines, budgets, and risk management, ensuring that clinical trials are delivered on schedule, within scope, and in compliance with regulatory and quality standards. The director will coordinate with clinical operations, medical, regulatory, biostatistics, and external partners to design, initiate, and manage global clinical trials. Day-to-day activities include managing program governance, preparing program-level reports and updates for leadership, driving protocol and operational strategy, optimizing site and vendor performance, and resolving issues that impact study conduct. The role also involves mentoring team members, supporting process improvement, and contributing to long-term portfolio and indication strategies within the autoimmune therapeutic area.
Qualifications
Role Description The Director of Clinical Program Management (Autoimmune) is a full-time remote role responsible for leading end-to-end planning and execution of clinical programs in autoimmune indications. This role oversees cross-functional program timelines, budgets, and risk management, ensuring that clinical trials are delivered on schedule, within scope, and in compliance with regulatory and quality standards. The director will coordinate with clinical operations, medical, regulatory, biostatistics, and external partners to design, initiate, and manage global clinical trials. Day-to-day activities include managing program governance, preparing program-level reports and updates for leadership, driving protocol and operational strategy, optimizing site and vendor performance, and resolving issues that impact study conduct. The role also involves mentoring team members, supporting process improvement, and contributing to long-term portfolio and indication strategies within the autoimmune therapeutic area.
Qualifications
- Demonstrated expertise in Clinical Operations, including planning, conducting, and overseeing complex clinical trials.
- Strong Program Development and program management skills, with experience leading multi-study or multi-indication clinical programs.
- Background in Medicine or related life sciences, with a solid understanding of autoimmune disease mechanisms and treatment landscapes.
- Experience with Clinical Trials in autoimmune or immunology, including protocol development, site management, and regulatory coordination.
- Awareness of Mental Health considerations in autoimmune populations and ability to integrate holistic patient-centric approaches into program design.
- Advanced degree in life sciences, medicine, pharmacy, or related field (MD, PhD, PharmD, or equivalent preferred; master’s degree with significant experience considered).
- Proven leadership skills, including managing cross-functional teams, influencing without direct authority, and mentoring staff.
- Excellent analytical, organizational, and communication abilities, with proficiency in remote collaboration and digital project management tools.
- Experience interacting with regulatory authorities, ethics committees, and external partners such as CROs and academic investigators.
- Track record of driving process improvements and implementing best practices in clinical development and program governance.
Vacancy posted 2 days ago
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