21 years of Global Regulatory Affairs and Quality Management at the leadership level for Pharmacia, Pfizer, Novartis, and Ispen
Oncology, Infectious Diseases; Neurology, Endocrinology, Specially Care and Primary care, Dermatology; Rare and Orphan Disease as well as Biologics, Medical Devices and Advanced Therapies
Over the 21 years in Regulatory Affairs, I have pursued innovative approaches to bring novel medications to the global markets that are patient focused. Many smaller biopharma companies partner to soon with global/large pharma companies to obtain their needed regulatory expertise and financial resources in order to increase the geographical approval potential and broaden their marketing footprint. However, for these small companies to maintain their intrinsic value with minimal external mandates, I have worked with successful small companies that have focused on developing a well-defined Global Regulatory Strategy Plan. To this end, I have provided solutions and given guidance that maximizes the value of clients’ development plans beyond just the US or EU markets but have sought to maximize value through a comprehensive Global plan. I work with clients to integrate, reorganize, launch and lead numerous regulatory plans and activities targeted to meet organizational objectives on both the products and corporations.
16 years of development experience spread across scientific, medical, device, regulatory, and pharmacovigilance fields in small biotech, large pharma, and global CROs.
Oncology; CNS; Neuroscience, Rheumatology; Gastroenterology; Dermatology, Ophthalmology, Cardiovascular/Metabolic, Immunology, Renal diseases, Women’s health, Rare & Orphan diseases, and Psychiatry.
Provide global strategic clinical/medical and regulatory guidance to client companies in the planning, development, and design for new drugs, biologics, and combination products across all clinical phases and therapeutic areas. Designing clinical development plans, study synopses/protocols, gap analyses, medical marketing plans, and go/no-go investment decisions. Performing sponsor portfolio review and management, due diligence for investment opportunities, key opinion leader management, and indication exploration for new assets or repurposing.
15 years of research & development experience in academia, clinical development, project/program management, and regulatory fields in large pharma and global CROs.
Oncology; CNS; Neuroscience; Dermatology, Ophthalmology, Cardiovascular/Metabolic, Immunology; and Rare & Orphan diseases.
Driven to lead cross-functional drug development teams with experience of having direct line accountability to Executive Leadership Team for the timely execution and management from IND submission through completion of NDAs or MAAs for client development projects or programs. Highly proficient in providing high-level strategic R&D evaluation of preclinical through lifecycle management drug development projects to ensure alignment within the portfolio of product as well as confirming overall business objectives.
Years of Experience
24 years of academic & clinical research, project/program management and business development experience in a large pharma organization and several global CROs.
Therapeutics Area Expertise
Diverse development background covering all phases of development from IND submission through to NDA submission and support. Therapeutic expertise in Oncology, Infectious Diseases, GI, Immunology and Virology.
Career Accomplishments/Development Interests
As a project management professional, I have designed, conducted, and overseen numerous global clinical programs that have sought to bring novel medications to patients in global marketplace. My core competencies include strategy development, study management, integrated project management and personnel management as well as having a proven track record for exceeding customer expectations, effective execution, and organizational planning. I have participated as a Functional leader representativePrinciple Consultant and Partner: on multiple development teams that have progressed leading Oncology, HIV and GI assets through the development process (Phase 1-4) and global submissions of marketing applications. And as a business development liaison, I have secured and provided primary financial oversight of many global multi-million dollar pharmaceutical assets.
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