THE ROLE

The company is expanding and looking for an experienced Head of Early Development. Reporting to CEO, the Head of Early Development will lead Augustine Therapeutic's research and early development non-clinical studies through early clinical development. Non-clinical studies relate to preclinical toxicology, DMPK supporting IND readiness and regulatory filings for pipeline candidate. Early clinical development relate to Phase 1 human clinical trials and related operations towards Phase 2-ready drug candidate stage. This leader will contribute to fostering the culture of innovation, as well as strategic and scientifically sound approaches for advancing novel therapies. This professional will work closely and collaborate with leaders across the company including medicinal chemistry, pharmacology, drug manufacturing and regulatory.
 

KEY RESPONSABILITIES:

• Devise and execute the late-stage non-clinical development strategy until early clinical development with the support of internal and external representatives and clinical experts.
• Create the target product profile based on interaction with KOLs and consultancy agencies and adjust this profile as new information and insights are gained. Communicate key program risks and potential solutions to R&D leadership and to the executive team in a transparent and timely manner.
• Assemble and coordinate early development teams for lead assets together. Ensure key proof-of-concept, pilot, and pivotal/IND-enabling studies are performed. These include supporting safety, toxicology, and pharmacokinetics that enable clinical exploration of novel therapeutics.
• As leader of early compound development team drive decision-making on compound strategy, ensuring relevant research, analysis, and expertise are taken into account.
• Support drafting of regulatory filings in collaboration with Augustine Therapeutics program leadership and management, regulatory and development operations group and the strategic curation and delivery of key content for non-clinical sections of INDs/CTAs support Phase 1 studies.
• Design and execute the early clinical development plan in accordance with industry standards and in alignment with the overall development strategy of Augustine Therapeutics. In addition will be responsible for the work planning and management.
• Ensure alignment of non-clinical activities with clinical development, drug manufacturing, and regulatory plans, including translational aspects and a biomarker strategy.
• Interact with Scientific Advisory Board as the representative for non-clinical and early clinical science
• Have key interactions with regulatory agencies as representative for non-clinical science and early clinical science (responses to queries, preparation of pre-meeting documents, attend teleconferences and meetings with health authorities, as needed)
• Ensure development and implementation of optimal IP, publication and regulatory strategies to protect and maximize asset value.
   

  PERSONAL STRENGTHS:

• Highly motivated, data-driven, rigorous, and curious scientist with high quality standards and proven ability to collaborate cross-functionally to deliver on program goals.
• Have a hands-on and solutions-oriented mindset.
• Highly capable leader and mentor.
• Entrepreneurial spirit thriving in the dynamic environment of a small company, willing to reach outside own discipline to ensure that projects are driven to success, and looking to create maximal value for stakeholders and patients with limited resources.
   

EDUCATION / EXPERIENCE / QUALIFICATIONS:

• PhD or MD/PhD degree in biology, pharmaceutical science, toxicology, veterinary pathology, or other closely related discipline is required.
• 10+ years of experience pertaining to IND enabling activities and related disciplines till early clinical stage, with a minimum of 5+ years applicable experience in field of small molecule therapies
• Excited about identifying and meeting the challenges inherent in bringing drugs with novel mechanisms of action into the clinic.
• Requisite and evidenced expert contributions and broad experience in executing and curating documentation for successful IND/NDA applications towards first-in-man studies.
• Established capacity to oversee and guide focused and efficient study execution efforts to generate key data with high scientific integrity and innovative value
• Strong quantitative skills and ability to represent the interpretation of non-clinical data to early discovery and clinical development project teams and to health authorities
• A track record of scientific accomplishments spanning the field as demonstrated through scientific publications, presentations, patents, and contributions to nonclinical/translational peer groups or consortiums
• Clear and influential communicator: exceptional influencing, negotiation and conflict resolution skills that demonstrate strong thought partnership and create effective relationships with internal and external stakeholders
• Excellent collaboration skills and ability to build and connect strong and high performing teams
• Actively contribute to a team culture that promotes continuous improvement, ownership, professional growth, and inclusion.
• Demonstrated scientific leadership experience, including demonstrated capacity to develop and mentor others.
  
  AUGUSTINE THERAPEUTICS OFFERS:
• An exciting job in a dynamic, international, early-stage biotech environment.
• An opportunity for fast intellectual and professional growth with a potentially life-changing impact on neuropathy patients.
• An opportunity to shape a new company and drive it to success.
• A competitive compensation package.
• Flexible work hours and the ability to work from home where possible.

LOCATION:
The role should be ideally based in Bio-Incubator Leuven, Gaston Geenslaan 1, 3001 Leuven, Belgium or be partially remote.