Summary
Overview
Work History
Education
Skills
Timeline

Dr. Med. Just Joachim Klaus Genius

Drug Development Executive
Victoria

Summary

Genius Biotech Solutions Ltd is consulting biotechnology and pharma companies with a focus on translational strategy support and all aspects of the design and execution of complex clinical trials, including clinical aspects, operational execution, biomarker strategy, regulatory aspects, safety and filing activities. I cover the entire spectrum of neurological diseases, including PD (as a focus area), AD, MS, FTD and ALS with additional focus on inflammatory diseases, fibrosis, NASH, vascular diseases and neuropediatric diseases, specifically orphan diseases. I am very experienced and have developed a dedicated tool in matching novel indications to emerging or existing pipeline assets, and supporting successful entry into new therapeutic areas. I am highly experienced in managing external stakeholders (key opinion leaders, patient advocacy groups and regulatory authorities). My company is operating from Gozo Island (Malta). Currently, I am mainly working for a biotech company from Switzerland (AC Immune, mainly PD, ALS and FTD as well as neuroinflammatory disorders and neurogenetic disorders). I collaborate with an artificial intelligence company providing services to optimize antibody design (EVQLV, New York) . I have generated the clinical protocols for an active PD vaccination program, which has just successfully proceeded into Phase 2 as well as for an early-stage program on FTD/ALS (therapeutic antibody and novel PET-tracer) and an early-stage program for tauopathies. Currently, I am clinical lead for a novel, anti-inflammatory compound exploring multiple potential, target indications and providing the necessary translation framework. This activity also includes intense, competitive intelligence work. For BioNtech, I have established a neurology strategy for compounds entering FIH, including all aspects of translational strategy, clinical design, KOL management and competitive intelligence. I have developed a new score-based methodology to optimize indication selection. A special focus is the digital transformation utilizing novel wearable technologies, computational biology and artificial intelligence to optimize signal detection in clinical trials.

Overview

23
23
years of professional experience
1
1
year of post-secondary education
3
3
Languages

Work History

Founder and CEO

Genius Biotech Solutions, Ltd
07.2021 - Current
  • Cultivated forward-thinking, inclusive and performance-driven company culture to lead industry innovations.
  • Managed financial, operational and human resources to optimize business performance.
  • Secured funding for company growth through investor relations and networking activities.
  • Oversaw business-wide changes to modernize procedures and organization.

Senior Medical Director, Neurology Development

UCB
01.2019 - 04.2021
  • Medical Lead and Digital Biomarker Workstream Lead for an early phase clinical development program (disease modification in early Parkinson’s Disease) achieving successful transition into Phase II
  • Led a large, multidisciplinary matrix team and one direct report ( Senior Medical Director, Neurology)
  • Clinical lead for the translational strategy including implementation of digital biomarkers in ongoing and planned Neurology development activities (collaboration with Google/Verily)
  • Led and oversaw development of POC strategies and beyond, also including commercial and regulatory activities as well as KOL outreach
  • Major contributions to projects directed against complement in multiple non-neurological diseases
  • Successfully and swiftly responded to the COVID crisis by implementing hybrid trial structures and remote monitoring options
  • Clinically led the strategy of the overall Neurology portfolio from early translation to first-in-man studies and the design and execution of proof-of-concept studies in several indications
  • This included the translational medicine and biomarker strategy for the Neurology Early Development pipeline in neurodegeneration and neuroinflammation
  • I have closely interfaced with colleagues from different backgrounds to improve the current outcome measures, e.g
  • By developing and validating more appropriate PRO scales and implementing novel digital tools (including artificial intelligence and deep learning approaches) as Clinical Workstream Lead for the Verily Collaboration
  • I have interfaced with internal Discovery functions and external consortia to support identification and further qualification of biomarkers (biochemical, imaging and digital)
  • Member of the FNIH Neuroscience Steering Board
  • I have also served as Medical Lead for an discovery stage gene therapy program in FTD to prepare candidate selection and transition into FIH
  • Ensured compliance with accreditation requirements through regular audits of facility operations and diligent record-keeping practices.
  • Worked with research and pharmaceutical organizations to conduct clinical trials.
  • Recruited, hired and trained all staff, providing direct supervision, ongoing staff development and continuing education to employees.
  • Drove planning for business development and relationship building with healthcare partners.
  • Verified effective, consistent communication between department heads, medical staff and governing boards through board meeting attendance and synchronization of interdepartmental functions.
  • Implemented innovative technologies to streamline workflows and improve overall patient experience.
  • Contributed to the growth and success of the organization by participating in regional and national conferences, sharing best practices with industry peers.
  • Collaborated with stakeholders to develop comprehensive medical programs addressing community needs.
  • Oversaw clinical trials, ensuring compliance with regulatory requirements and ethical standards.
  • Reviewed material used by medical team as part of Medical Review Board standards.
  • Monitored industry trends and advances in evidence-based medicine to purchase and utilize innovative equipment while maintaining operating budgets and expenditures.
  • Championed a culture of continuous learning within the organization, encouraging staff to pursue ongoing education opportunities relevant to their roles.
  • Mentored physicians and other medical staff, facilitating professional development through training programs.
  • Enhanced operational performance by identifying areas of improvement and implementing change management strategies.
  • Interpreted [Type] results and provided recommendations to treat variety of [Type] disorders.
  • Developed strategic plans to achieve organizational goals and ensure long-term success in the medical field.
  • Managed multidisciplinary teams, fostering collaboration between various healthcare professionals for optimal patient care.
  • Designed and introduced leadership development, coaching and team management model, resulting in promotion of employees into increased levels of responsibility.
  • Established and maintained effective communication with staff, physicians and community organizations to promote high quality patient care.
  • Defined testing protocols, quality assurance initiatives and clinic policies and procedures.
  • Negotiated contracts with vendors, securing cost-effective supplies while maintaining high-quality standards for equipment and materials used in patient care.
  • Evaluated vendor contracts for practice specialists and operations staff, and reviewed non-contracted instrumentation technology vendor agreements.
  • Optimized resource allocation by analyzing departmental budgets and reallocating funds where necessary for maximum impact on patient care.
  • Developed and updated policies and procedures, maintaining compliance with guidelines relating to HIPAA, benefits administration and general liability.
  • Established partnerships with external organizations, promoting collaboration on shared health initiatives.
  • Developed alliances with internal departments resulting in improved communication and performance throughout region.
  • Spearheaded and implemented new projects to expand scope of engagement.
  • Supervised clinical staff, providing continuous professional development opportunities and training to maintain and strengthen competencies.
  • Self-motivated, with a strong sense of personal responsibility.
  • Identified issues, analyzed information and provided solutions to problems.
  • Strengthened communication skills through regular interactions with others.
  • Demonstrated strong organizational and time management skills while managing multiple projects.
  • Worked well in a team setting, providing support and guidance.
  • Gained strong leadership skills by managing projects from start to finish.
  • Proven ability to develop and implement creative solutions to complex problems.
  • Demonstrated a high level of initiative and creativity while tackling difficult tasks.
  • Proved successful working within tight deadlines and a fast-paced environment.
  • Acted as a team leader in group projects, delegating tasks and providing feedback.

Medical Director

AbbVie, Discovery
10.2016 - 12.2018
  • Head of Translational Biology at AbbVie Discovery (iSAT, Future Therapeutics and Therapies), USA
  • Providing managerial direction and clinical and scientific guidance to early-stage drug development/discovery in multiple therapeutic areas
  • Managing one direct report (Principal scientist and biochemist) and a global matrix team
  • Providing clinical and translational support to early-stage assets within the AbbVie-Calico collaboration as the Clinical Lead
  • Assessment of developmental strategies and exploratory aspects in rare, neuropediatric and neuro-opthalmological diseases, as well as fibrotic diseases (renal, skin, lung)
  • Leading translational plan development and clinical planning for rare childhood leukencephalopathy
  • Leading a team to establish a novel microarray platform to evaluate the potential of small molecules in modulating cell surface glycan composition application in neurodegeneration, neuroinflammation, vascular diseases and fibrosis
  • Co-leading a project on optimizing antibody targeting by utilizing specific protein glycoforms
  • Protocol development for Phase 0 to Phase 3
  • Clinical safety monitoring of several Phase 0 and Phase 1 studies in immunology and neurosciences, including novel applications for TSPO PET, advanced retinal imaging and nonconventional imaging (MRI).
  • Reviewed material used by medical team as part of Medical Review Board standards.
  • Collaborated with legal, accounting and other professional teams to review and maintain compliance with regulations.
  • Initiated strategy to drive company growth and increase market share and profitability.
  • Formulated and executed strategic initiatives to improve product offerings.
  • Played a crucial role in accreditation procedures and regulatory compliance, maintaining high standards of patient safety and care delivery.
  • Represented organization at industry conferences and events.
  • Evaluated vendor contracts for practice specialists and operations staff, and reviewed non-contracted instrumentation technology vendor agreements.
  • Established and maintained strong relationships with customers, vendors and strategic partners.
  • Developed alliances with internal departments resulting in improved communication and performance throughout region.
  • Monitored key business risks and established risk management procedures.
  • Interpreted [Type] results and provided recommendations to treat variety of [Type] disorders.
  • Championed innovation by staying abreast of emerging technologies relevant to the healthcare industry while identifying potential areas for integration within the organization.
  • Oversaw divisional marketing, advertising and new product development.
  • Mentored junior physicians and staff members, cultivating a culture of continuous learning and professional development within the organization.
  • Verified effective, consistent communication between department heads, medical staff and governing boards through board meeting attendance and synchronization of interdepartmental functions.
  • Developed innovative sales and marketing strategies to facilitate business expansion.
  • Enhanced interdisciplinary collaboration for better patient outcomes by fostering strong relationships with healthcare professionals across various departments.
  • Developed strategic plans and initiatives for the organization''s growth, ensuring long-term financial sustainability and operational excellence.
  • Supervised clinical staff, providing continuous professional development opportunities and training to maintain and strengthen competencies.
  • Represented staff at meetings and on designated committees relative to areas of specialty or service.
  • Monitored industry trends and advances in evidence-based medicine to purchase and utilize innovative equipment while maintaining operating budgets and expenditures.
  • Facilitated knowledge exchange among peers through regular conferences, seminars, workshops, ultimately elevating the standard of care across the organization.
  • Analyzed industry trends and tracked competitor activities to inform decision making.
  • Oversaw and developed clinical departments through hiring, training and evaluating staff.
  • Devised and presented business plans and forecasts to board of directors.
  • Worked effectively in fast-paced environments.
  • Gained strong leadership skills by managing projects from start to finish.
  • Learned and adapted quickly to new technology and software applications.
  • Excellent communication skills, both verbal and written.
  • Used strong analytical and problem-solving skills to develop effective solutions for challenging situations.
  • Proved successful working within tight deadlines and a fast-paced environment.
  • Self-motivated, with a strong sense of personal responsibility.
  • Acted as a team leader in group projects, delegating tasks and providing feedback.
  • Managed time efficiently in order to complete all tasks within deadlines.
  • Demonstrated a high level of initiative and creativity while tackling difficult tasks.
  • Demonstrated leadership skills in managing projects from concept to completion.

Associate Medical Director

AbbVie Neuroscience Development
10.2014 - 9 2016
  • Clinical lead for first in human and early stage drug development for progressive MS (anti-RGMa) and spinal cord injury, including IND submission, trial design, generation of a translational plan and safety monitoring
  • Exploring novel indications in neurology and neuropediatry by developing a customized scoring system and integrating computational biology
  • Implementation of biomarkers in clinical studies for enrichment and as novel clinical endpoints in progressive forms of MS, including nonconventional imaging and novel biochemical tools
  • Exploration and assessment of retinal imaging (OCT) as novel translational tool for neurological and neuro-opthalmologic conditions
  • Developing a communication strategy for early access in rare diseases
  • Exploring business options, engagement strategies and clinical-translational plans for multiple genetic neuropaediatric orphan diseases
  • Supporting clinical trial designs with innovative adaptive elements and contributing to digital transformation
  • Providing clinical expert support to clinical development strategies in the field of MS and alternative indications (Spinal cord injury, ALS, FTD, LHON, Huntington, neuropaediatric storage disorders and neuropaediatric leukencephalopathies) including identification of KOLs and formation of advisory boards
  • Assessment of in-licensing opportunities for MS, AD, PD, ALS and retinal diseases under aggressive timelines for AbbVie and the AbbVie-Calico collaboration
  • Participation in regulatory activities (promoting acceptance of novel biochemical biomarkers in AD and MS)
  • AbbVie representative in industry-academic partnerships and consortia (ADNI-PPSB, CAMD) with focus on biofluid biomarkers
  • Scouting for novel technologies relevant for ongoing development programs
  • Established collaborative partnerships with US study sites for MS clinical trials, including selection, teaching, surveillance and authoring of documents
  • Clinical oversight over first-in-human/first-in-class trial with anti RGMa antibodies
  • Developing strategies for safety signal identification and implementation of mitigation strategies
  • Leading teams responsible for periodic and ad hoc safety reports and presenting data to monitoring boards, FDA and other regulatory authorities.

Non-clinical Research Assistant and Project Leader

University of Duisburg
02.2012 - 09.2014
  • Essen
  • Supervising PhD and MD students.

Resident physician and researcher

Clinical Neurobiology
02.2004 - 12.2011
  • University of Munich)
  • Research focusing on the molecular background of schizophrenia and neurogenetics with acquisition of substantial third party funding
  • Research projects on pathomechanism of ALS and potential interventions
  • Implementation of new translational in vivo and in vitro models
  • Supervising physician in units for general psychiatric care (focus on personality disorders and affective disorders) and for neurodegenerative disorders
  • Special training in Dialectic Behavioral Psychotherapy (DBT) and suicide intervention
  • Sub-investigator in several clinical studies (anti-dementive therapies, including vaccination and neurochemical/imaging biomarker studies
  • Tutor for Neurology and Psychiatry within the Munich-Harvard Teaching Alliance Program and the MECUM-Program
  • Experience in teaching (seminars, bedside teaching) for many years
  • Independent supervisor of several MD and PhD students
  • Psychiatric expert witness in high-profile criminal and civil court cases.

Junior House Officer

University of Heidelberg
01.2001 - 01.2004
  • Research projects on the neurogenetics of cerebrovascular disease and evaluation of neuroprotective compounds in stroke models
  • Investigator in diverse clinical studies.

Education

M.D. - Medicine

Medical University of Lübeck, Lübeck, Germany
04.1993 - 04.1994
  • [PAT or SAT] [Number] Score
  • Degree Awarded with [Honors]
  • [Scholarship Name], [Year Awarded] from [Awarding Body]
  • Dissertation: [Dissertation Title]

Skills

Strategic Vision

Timeline

Founder and CEO - Genius Biotech Solutions, Ltd
07.2021 - Current
Senior Medical Director, Neurology Development - UCB
01.2019 - 04.2021
Medical Director - AbbVie, Discovery
10.2016 - 12.2018
Associate Medical Director - AbbVie Neuroscience Development
10.2014 - 9 2016
Non-clinical Research Assistant and Project Leader - University of Duisburg
02.2012 - 09.2014
Resident physician and researcher - Clinical Neurobiology
02.2004 - 12.2011
Junior House Officer - University of Heidelberg
01.2001 - 01.2004
Medical University of Lübeck - M.D., Medicine
04.1993 - 04.1994
Dr. Med. Just Joachim Klaus GeniusDrug Development Executive