Melissa Vadnais, Vmd, Phd Email & Phone Number

Durham, Nc, Us

United States

- Drive strategic planning and execution of program deliverables: Develop and manage complex project plans that include precise timelines, budget allocations, resource distribution, and comprehensive risk mitigation strategies.- Develop protocol synopsis, clinical development plan, press release, advisory boards, and strategic regulatory plan.- Lead and synchronize a cross-functional team: Collaborate with regulatory affairs, CMC, clinical operations, and finance teams to align with program objectives.- Maintain communication with senior management and stakeholders: Provide updates on program progress, risks, challenges, and opportunities.- Develop and maintain external vendor and collaborator relationships.

Durham, North Carolina, United States

- Transition developmental neurology/rare and orphan disease products to market by understanding the scientific, clinical, and payer landscapes. Strong focus on ASOs and gene therapy/genetic involvement in ALS and PD. - Gather actionable clinical/scientific insights, translate into strategies, develop real-world evidence strategic plan.- Work as part of Medical Strategy Team to ensure coordination/alignment of medical affairs activities and budget.- Consult on pre-IND products within R&D, working with multiple stakeholders developing strategy for development.- Lead cross-functional teams to create global launch plans, field resources, and optimize processes within Medical Affairs reducing redundancy, ensuring alignment and compliance, and ability to meet global business objectives.- Build relationships, educate internal and external stakeholders through creation of educational content and presentation, work closely with patient advocacy groups, and develop agenda/content for advisory boards.- Experience with NDA filing and pre/post launch activities with in-depth knowledge of CSRs. - Member of Global Publications Team, serving as liaison to the nonpromotional review committee and strategically identifying submission targets.

Durham, North Carolina, United States

- Served as a clinical consultant for on- and off-label queries related to our medical devices and clinical results. - Coordinated medical advisory boards and developed symposia and educational events focused on hemostasis, patient blood management, and product launch.- Managed company-sponsored clinical studies intended for expanding product claims and provide support for investigator-initiated studies. - Developed protocols and attended and supported clinical site initiation and closeout visits. - Reviewed and analyzed clinical study data/CSR, initiate/collaborate/author publications as well as presentations, and supported regulatory filings, 510(k) and CE mark. - Supported internal initiatives through collaboration with internal stakeholders as a clinical and scientific subject matter expert to develop field materials and deliver training and support.

Raleigh-Durham, North Carolina Area

- Established and maintained clinical and scientific relationships with physicians, researchers, and medical societies.- Developed clinical trial protocols for successful drug development in the fields of CNS, orphan diseases, respiratory diseases, as well as liver and kidney diseases.- Presented data and plan development ideas to business colleagues and key opinion leaders in the field.- Worked as a liaison and consultant with sponsors to gain insight into their needs for drug development and clinical trial execution.- Collaborated with all business units to ensure accurate data dissemination, clinical trial compliance, statistical analysis, regulatory and payer buy in, as well as adherence with budget and timeline.- Partnered with regulatory affairs to help in regulatory submissions to the FDA and EMA.- Worked closely with Centers of Excellence and patient advocacy groups to understand patient enrollment and clinical trial feasibility.

Raleigh-Durham, North Carolina Area

- Collaborated with key opinion leaders in pharmaceuticals by building relationships, communicating data, and forming partnerships to work on research projects and clinical trials. - Engaged in scientific exchange with healthcare professionals and investigators by serving as a liaison between medical and scientific communities utilizing expertise gleaned from dual medical and science degrees.- Generated new ideas and identified novel applications of development plan strategies and tactics through researching current practices and treatments in medicine and targeting areas of need. - Formulated research plan on drug development and proposed recommendations to review board for developing a non-reversible sterilant for companion animals; lined up collaborators to facilitate R&D and clinical trials.- Worked with customers to gain insight into their needs, product and competitor product satisfaction following product launch in the US.- Delivered scientific support to team of researchers, investigators and collaborators to ensure accurate data dissemination, research progression, and compliance with budget and timeline. - Communicated trends in the field to the business, quickly developing a network of strategic relationships with vendors, academics, CROs, investigators, and governmental officials to achieve business objectives.

La Jolla, Ca

* Facilitated scientific interactions with multiple scientific groups located nationwide, working on HIV vaccine development while ensuring goals were meeting medical need and improving patient health. * Operated with highest level of professionalism to forge powerful collaborations and relationships with the scientific community, healthcare professionals, patient groups, and government officials.* Presented research data to multiple audiences including patient groups, scientific conferences, industry meetings, and healthcare providers; praised for ability to present and accurately disseminate data to multiple different groups.* Developed and formulated new research ideas and research techniques. * Participated in and contributed to project teams, including overseeing interns and technicians and cultivating a positive performance environment by providing tools and direction needed.

* Liaised between physicians in the department of obstetrics and gynecology and researchers in the Center for Research on Reproduction and Women’s Health. * Ensured accurate data dissemination, providing scientific input leveraging solid understanding of medical and patient need, and securing key partners for science and clinical research. * Conceptualized and provided new ideas, project planning, data generation, and analysis, while maintaining accurate records in accordance to governmental, university, and scientific regulations. * Presented at scientific conferences, securing peer-to-peer relationships and scientific collaborations. * Trained graduate/undergraduate students, physicians, technicians, and post docs in specific scientific methods and surgeries; educated on specific therapeutic areas and disease states as it pertained to their projects. * Maintained knowledge base in the area of reproduction, women’s health, and environmental toxicology by understanding publications/medical publications, attending seminars, and engaging with key opinion leaders. * Remained abreast of internal and external information sources including data sets, published research in peer reviewed journals/books, internal databases, gained access to external databases through networking.

* Presented clinical and disease state information to clients, attending physicians, grand rounds, and investigators. * Responded, within defined timeline and quality standards, to inquiries from healthcare providers and scientists. * Conducted therapeutic training for medical colleagues and clients. * Communicated key medical insights from medical colleagues to inform refinement of medical strategies or processes.* Listened to client insight and incorporated feedback to improve patient health, client satisfaction, and client compliance. * Developed and increased knowledge of medical literature and critical appraisal of scientific and medical publications. * Gained a solid foundation in medicine across all disciplines, enabling ability to work in any therapeutic field.

* Enhanced knowledge of medical and scientific literature. Critically evaluated literature. Maintained knowledge base and scientific expertise in my specialized area. * Provided new ideas and constantly searched for novel applications; developed an assay to evaluate specific markers on sperm cells. * Partnered with pharmaceutical companies to perform laboratory research on their clinical trials, playing key role in safety and efficacy studies for both Viagra and Cialis.

* Acted as a scientific liaison between production operations and academic investigators also working with local governmental officials to ensure compliance and best practices. * Ensured scientific exchange by fostering medical and scientific communications promoting public health. * Trained graduate and medical students in specific therapeutic areas, medical diagnostics, and scientific assays.

Vmd, Veterinary Medicine

Focused on Many Species One Health initiative and translational medicine.

Phd, Cell And Molecular Biology

Msc, Cell Biology

Bsc, Biology