Development Project Lead

Confo Therapeutics

Zwijnaarde, Belgium

We are seeking an experienced and motivated individual to join us as the Development Project Leader. You will play a key role in the development organization to bring preclinical candidates through the IND/CTA application process and in early clinical development. Deliverables include scientific input and oversight, monitoring of studies, strategic planning, budget, and timeline management, as well as regulatory document review. This position reports to the Chief Development Officer and will frequently interact with Discovery, insourced staff, external consultants and CROs/CDMOs, Quality, Finance, Human Resources, site operations, and the company’s management team.

Your Responsibilities:

Provide project and team leadership (including insourced staff and external consultants) to support the pre-clinical and early clinical development of Confo’s pipeline assets;
Support the Development organization in providing scientific leadership and oversight and coordination of all pre-clinical and early clinical development activities for both NCEs and NBEs. Manage relationships with CROs/CDMOs, including requests for proposals, vendor selection (in coordination with Quality), review of contracts and statements of work with Legal, study proposals, (pre)clinical protocol drafting, pre-IND study monitoring and finalization and reporting of results, etc. in accordance with Confo’s internal procedures;
Work closely with Discovery Pharmacology and the Discovery Project Leads on strategy, forward planning, and proactive risk mitigation, to reach key milestone achievements spanning early research to post IND and early clinical activities. Specifically, formulate the project strategy for translation of preclinical biomarkers and their incorporation in clinical trials, in alignment with Discovery Pharmacology, including the development of assays and the execution of studies;
Ensure adequate resourcing to meet key deliverables, ensure timely follow-up on action items and proactively identify and escalate risks/issues in real time. File and maintain project information on secure data sharing platforms, create and maintain project plan documents, and effectively collect, summarize, and integrate information to generate high-level timelines and budgetary summaries for key stakeholders, including the management team. Assist with preparation of project presentation material (e.g., PowerPoint slides) and be a proficient user of project management tools. Be able to present project results and strategy both internally and externally;
Facilitate effective cross-functional communication between Discovery and Development, internal and external KOLs, be adaptable in executing on decision-making activities that meet realistic timelines. Support external collaborations and licensing efforts, including partnering and due diligence activities, by assembling and reviewing data packages and other tasks as required;
Some travel (domestic and international) may be required depending on business needs.

Job requirements:

PhD or equivalent in a scientific discipline, or/and at least 7 years of relevant experience in the pharmaceutical industry and specifically in drug development projects is essential;
Knowledge of and experience in small molecule and/or biologics drug development, specifically around the main activities leading to and including IND and/or CTA submission, is essential, e.g., familiarity with the general principles of DMPK, toxicology and safety assessment, CMC and early clinical development (Phase 1 and proof-of-concept);
Experience in preparation and/or review of regulatory documents such as INDs, CTAs, clinical study reports and briefing documents is essential; general knowledge of global regulatory guidance documents (e.g., ICH) is a strong plus;
Hands-on experience in Project Management is essential, and MS Project experience is a strong plus;
You are a highly collaborative, self-motivated, team-oriented individual, able to work in a fast-paced, highly integrated team environment where accuracy, accountability and timelines are essential, you are fluent in English and with excellent communication skills.

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