Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment. At Allucent, our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and applying your scientific knowledge, clinical expertise, and experience to partnerships with our clients in small and mid-sized biotech companies.
These customers have new therapeutic ideas, but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You’ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you’ll help make a positive difference in patients’ lives.
The Feasibility Manager (FM) produces and oversees recommendations for country and site selection strategies, as well as enrollment projections and subject recruitment strategies within the Global Study Start-Up and Site Intelligence department.
This position assures the integrity and proper interpretation of used data sources and the resulting strategy provided in feasibility proposals and reports. The FM supports Business Development (BD) as well as CTO.
This position is within our Pre-Award division.
Location: Poland or Eastern EU
- Provide input to proposals and business development to help build project assumptions, budget, and timelines (including overall recommendations on the countries, number of sites and projected number of patients).
- Identify and present regions where the disease is prominent to create an initial country pool to be further refined based on corporate experience, operational capabilities, medical input, and other feasibility considerations
- Identify the incidence and prevalence of the disease / syndrome
- Analyze competing clinical trial landscape in order to assess study feasibility and identify barriers for enrollment.
- Access open source and proprietary databases to determine similar patient populations and or therapeutic classes of drugs under investigation.
- Determine whether the countries proposed have comparator drug access/reimbursement. As appropriate, prepare tabular displays of this information for evaluation by the feasibility stakeholder pool.
- Represent Allucent’s global or regional expertise by presenting our study footprint in the indication, which may include compiling corporate experience, and expertise in specific indication when needed.
- Work with Allucent’s medical experts / KOLs on the conduct of the study as well as its acceptance and standard of care in target regions.
- Collaborate with Global Study Start-Up to determine strategy, regulatory pathway and timelines associated with the conduct of the proposed study.
- Conduct/oversee the conduct of post-award feasibility studies with potential sites as required, in order to select the most appropriate sites for the execution of Allucent studies.
- Write or oversee the writing of feasibility reports for clients as required.
- Present and explain feasibility analysis to BD/Clients (e.g. during bid defense meetings), including the process, recommendations and rationale.
- Proactively provide input to clinical project teams on patient recruitment & retention strategies to prevent and mitigate recruitment issues
- Maintain internal libraries and databases related to feasibility
- Expand and maintain site and investigator network
- Assure the Feasibility function interfaces effectively with all other key operating departments within Allucent
- Review and approve reports and manuscripts, as necessary, within management structure.
- Maintain current knowledge of regulations, guidelines and technologies appropriate for functioning in this capacity.
- Comprehensive benefits package
- Competitive salaries per location
- Departmental Study/Training Budget for furthering professional development
- Flexible Working hours (within reason)
- Opportunity for fully remote/hybrid working
- Leadership and mentoring opportunities
- Internal growth opportunities and career progression
- More task variety
- Financially rewarding internal employee referral program
- Access to online soft-skills and technical training via GoodHabitz and internal platforms
To all recruitment agencies: Allucent does not accept agency resumes. Please do not forward resumes to our careers alias or other Allucent employees. Allucent is not responsible for any fees related to unsolicited resumes.
- Experience in pre-award preferred.
- Bachelor's Degree in a life sciences field is required. Masters Degree or Ph.D. in Healthcare or Biological Science is preferred. Minimum of 5 years of experience in drug development and/or clinical research; or equivalent combination of education, training, and experience.
- Minimum 5 years of Global Feasibility & Site Identification experience; experience in strategic feasibility preferred.
- Basic knowledge of ICH-GCP, GDPR/HIPPA, CFR/CTR/CTD and applicable (local) regulatory requirements
- Demonstrable experience with analytics involving large datasets.
- Strong written and verbal communication skills including good command of English language
- Representative, outgoing and client focused
- Demonstrated knowledge of government/international databases, open-source databases or more proprietary databases (e.g., PubMed/Medline, ClinicalTrials.gov, Citeline)
- Ability to interpret data sources and translate information in clear and usable recommendations
- Demonstrated ability to form strong working relationships with other groups within the organization essential to high-level performance in this position
- Ability to work in a fast-paced challenging environment of a growing company
- Administrative excellence
- Proficiency with various computer applications such as Word, Excel, and PowerPoint required