ProPharma Group is the leading global, independent, single-source provider of regulatory, clinical, and compliance services serving pharmaceutical, biotechnology, and medical device companies. Our team of experts brings a comprehensive portfolio of regulatory sciences, clinical research solutions, life science consulting, R&D technology, pharmacovigilance, and medical information services to help solve complex challenges in a dynamic regulatory environment. With our mission to improve the health and safety of patients, we are focused on delivering the highest quality of services throughout the full product lifecycle.
The Director of Clinical Operations Strategy is a key contributor in early client engagement and is responsible for developing client-centric solutions by designing both strategic and methodological approaches to ensure project wins. Ability to take ownership of developing responses for RFIs, RFPs, and capabilities presentations related to clinical operations services and operations delivery Works with Business Operations and Clinical Operations leadership to develop budgeting standards for RFPs and RFIs for clinical operations services. May support development of refined bidding algorithms as assigned Contributes to Clinical Operations strategy in RFI and RFP text Initial point of contact in early client engagements with business development and Clinical Leadership Assist in the development of bid defense materials and serve as clinical operations contact for bid defense preparation and attendance as assigned Works closely with Clinical Operations leadership to lead, and suggest and implement process improvements to enhance operational delivery Assist in other operational duties as directed by Clinical Operations leadership Broad protocol and therapeutic area knowledge preferred; must have knowledge in oncology, CNS, rare disease, respiratory, and infectious disease therapeutic areas Experience in pharma and MD IVD space is a plus Comprehensive global knowledge, awareness, and practical understanding of the biopharma industry, drug development lifecycle and operational clinical trial delivery Robust and current knowledge of scientific, clinical, regulatory, commercial, and competitive landscape in multiple therapeutic areas or ability to research and summarize current landscape Strong technical and computer skills to support data analysis, customization, and reporting Strong relationship development, communications, presentation, and negotiations skills Demonstrated ability to interact across numerous functional groups (both external and internal stakeholders) and in a team-based work environment Ability to respond quickly with concise answers to client questions (“think on your feet mentality ) Bachelor’s degree or advanced degree in life science preferred. Candidates with the equivalent combination of education, training, and experience will be considered. 10 years of progressive leadership in Clinical Operations including direct clinical project management experience or equivalent. Experience and understanding of all phases of clinical development and ability to contribute to Clinical Operations budgets during the development, review, and implementation phases. Proven track record in operational delivery and or drug development; or equivalent combination of education, training, and experience. Extensive experience with Clinical Project Management with ability to understand, explain and communicate project concepts and put into detailed plans. Knowledge of FDA and or ex-US Regulations, ICH GCP Guidelines, and any other applicable regulatory requirements that govern conduct of clinical trials. Demonstrated track record as a self-starter, showing personal initiative and resourcefulness to drive results. Recent experience in operational and or business development roles at a biotechnology company or CRO (preferred).HIRED: Douglas Baker (DJBJNB MSN.COM) | INTERVIEW HM Phone Interview: Angela Iheanacho (aai110.ai gmail.com)
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
ProPharma Group is the leading global, independent, single-source provider of regulatory, clinical, and compliance services serving the pharmaceutical, biotechnology, and medical device companies. Our team of experts brings a comprehensive portfolio... Read More
