MBAbout Manolo
Hope is not a strategy!
As a transformative Chief Medical Officer with over 28 years of experience, I specialize in aligning clinical development, regulatory, and commercial strategies to drive innovation and ensure market success in Pharma, Biotech, and CROs.
𝗖𝗼𝗿𝗲 𝗦𝘁𝗿𝗲𝗻𝗴𝘁𝗵𝘀:
- Clinical Development Excellence: Expertise across Phases I-IV, PASS, epidemiological studies, and HE&OR strategy integration.
- Regulatory Mastery: Proven track record in FDA and EMA submissions, ensuring compliance and accelerated approvals.
- Commercial Vision: Strategic insights into competitive landscapes, enabling successful product launches.
𝗪𝗵𝗮𝘁 𝗦𝗲𝘁𝘀 𝗠𝗲 𝗔𝗽𝗮𝗿𝘁:
My holistic approach considers the medical perspective to ensure clinical value, regulatory compliance to achieve market readiness, and commercial strategy to position products for competitive success. By integrating these domains, I enable organizations to:
- Select optimal preclinical models targeting promising indications.
- Streamline development timelines while minimizing risks.
- Achieve faster, more impactful market entry.
With extensive experience leading clinical trials (100+), designing protocols (50+), and reviewing proposals (500+), I help organizations innovate and succeed in a rapidly evolving healthcare landscape.
Let’s connect to explore how I can help transform your clinical development strategy into measurable success.
Website: manolobeelke.com
German
Native or bilingual
Italian
Fluent
French
Basic
English
Fluent
Can work on-site
Herscheid (up to 50km)
Experience
- verum.deChief Medical OfficerJuly 2022 - Today (3 years and 11 months)Herscheid, NW, Germany• Lead medical and scientific oversight for global clinical trials, optimizing timelines and improving operational efficiency by 15%.• Develop and implement innovative trial designs, strengthening sponsor engagement and regulatory compliance.• Cultivate Key Opinion Leader (KOL) networks to enhance the CRO's scientific credibility and industry influence.
- IndegeneSenior Medical AdvisorDecember 2021 - Today (4 years and 6 months)Princeton, NJ, USA
- Designed and optimized clinical development strategies across multiple therapeutic areas, including Neurology, Oncology, and Rare Diseases, enhancing trial efficiency and regulatory success.
- Conducted due diligence assessments for biotech investments, providing critical insights into product viability, risk assessment, and strategic positioning.
- Advised pharma and biotech firms on accelerated regulatory pathways, FDA/EMA submissions, and compliance strategies to streamline approval processes.
- Supported trial design for biosimilars, small molecules, and novel therapies, ensuring scientific rigor and regulatory alignment.
- Engaged with investors and key stakeholders, identifying high-value assets and guiding funding decisions and partnerships.
- CHDI FoundationRegulatory Affairs ConsultantMay 2020 - Today (6 years and 1 month)Princeton, NJ, USA
- Provide regulatory strategy and oversight to support CHDI's mission of accelerating the discovery and development of therapies for Huntington's disease.
- Advise on regulatory frameworks for clinical research programs, ensuring alignment with FDA, EMA, and global regulatory expectations.
- Guide the development of investigational new drug (IND) and clinical trial application (CTA) strategies, facilitating regulatory interactions for novel Huntington's disease therapies.
- Support CHDI's research collaborations with academia, biotech, and industry partners, ensuring that early-stage translational research aligns with regulatory best practices.
- Provide strategic input on biomarker validation, trial design considerations, and clinical endpoint selection to optimize regulatory pathways for potential therapies.
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Education
- MDUniversity of Genoa, Italy1990Medicine and Surgery, whith doctoral thesis in Neurology and Sleep Medicine
- PhDUniversity of Bologna, Italy2002Research and Thesis in Sleep Medicine