For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
Essential Functions:
Lead the development and implementation of therapeutic strategies that align with client goals and market trends.
Support early engagement with customers (ahead of RFP submission) alongside BD team, providing PPG background and therapeutic alignment for indication.
Drive innovative strategies on assigned opportunities; protocol or operational suggestions, budget comparison with similar bids or region-specific recommendations to maximize program delivery and increase likelihood of award
Conduct comprehensive market assessments to identify opportunities and challenges within various therapeutic areas.
Collaborate with internal teams, including medical, operations, regulatory affairs, and commercial to ensure a cohesive approach to client engagements.
Stay abreast of industry trends, emerging therapies, and competitive landscapes to inform strategy development.
Ability to take ownership of developing responses for RFIs, RFPs, and capabilities presentations related to therapeutic strategy and operations delivery
Apply extensive business and industry expertise.
Apply strong knowledge of global regulatory requirements and ICH / GCP guidelines.
Work with Business Operations and Clinical Operations leadership to develop budgeting standards for RFPs and RFIs.
Support development of refined bidding algorithms as assigned.
Assist in the development of bid defense materials and serve as clinical operations contact for bid defense preparation and attendance as assigned.
Work closely with Clinical Operations leadership to lead and suggest and implement process improvements to enhance operational delivery.
Drive continuous improvement therapeutic initiatives and consult with customers and teams that support the customer portfolios, leveraging feedback, metrics, and best practices to optimize patient recruitment and outcomes.
Cultivate a culture of accountability, transparency, and collaboration within the team and across the organization, promoting knowledge sharing and cross-functional teamwork.
Provide regular reports and updates to senior leadership on the status, progress, and performance of key projects and initiatives, highlighting achievements, challenges, and recommended actions.
Mentor and develop junior team members, fostering a culture of excellence and continuous learning within the therapeutic strategy team.
Other duties as assigned.
Necessary Skills and Abilities:
Proven track record of successfully leading strategic initiatives and managing client relationships
Proven ability to drive and contribute to organizational results.
Strong analytical and problem-solving skills, capable of conveying complex ideas to diverse audiences.
Broad protocol and therapeutic area knowledge.
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 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.
Excellent verbal and written communication skills.
Ability to work independently and collaboratively, as required, in a fast-paced environment consisting of internal and external team members.
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
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”).
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.
Proven track record in operational delivery and / or drug development; or equivalent combination of education, training, and experience.
Educational Requirements:
Bachelor’s degree or advanced degree in life science preferred. Candidates with the equivalent combination of education, training, and experience will be considered.
Experience Requirements:
10+ years of progressive leadership in life sciences industry including direct clinical project management experience or equivalent with a focus on therapeutic strategy and consulting.
Experience and understanding of all phases of clinical development and ability to contribute to study budgets during the development, review, and implementation phases.
Appropriate level of industry and delivery challenges and issues with the ability to support root cause analysis and support strategies to course correct.
Recent experience in operational and / or business development roles at a biotechnology company or CRO (preferred).
Strong knowledge of global regulatory requirements and ICH / GCP guidelines.
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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.
All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.
Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***