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Work Background
FRTLTbizFounder
Oct. 2023• Provide consulting services to pharmaceutical companies in Medical Information, Pharmacovigilance, Quality Management and Clinical Development. • Specialize in Women's Health with a mission to expand access to women's health and infertility services. • Bring expertise of the business side of health care a pharmaceuticals with an in-depth understanding of managed care and PBMs • Specialize in Medical Affairs, medical communications and writing, and scientific expertise in disease states such as endocrinology, immunology, neurology and oncology.
Granata BioHead of Scientific Affairs
Oct. 2023 - Jan. 2025United StatesBegan working as a consultant in October 2023 and transitioned to a full time role in March 2024. directs ~35 vendors across international regulatory and quality management teams globally to optimize clinical trial processes and ensure compliance; serves as an SME on clinical development protocols and study reports. Ensures patient safety and regulatory compliance for new drug launches by developing adaptive pharmacovigilance programs. Enhances drug development protocols. Life cycle management of drug development • Fluent in GxP, ICH, FDA, EMA • Oversee Clinical Drug Development Program
• Working with study protocol, method development and validation from a clinical and regulatory standpoint
• Strengthened governance and scientific decision-making by spearheading the creation of a scientific advisory board. • Oversee pre-clinical and CROs for early stage research
• Clinical writing for FDA communication
• Writing clinical trial protocols
• Oversee lab development of Bio-A assays
Supervised Clinical Quality Management Program
Initiated Pharmacovigilance Program and MedInfo Department
• Oversee Clinical Quality Management Program Proficient in Code of Federal Regulations (CFR) title 21, part 11. • Participated in fundraising activities
• Assisted with due diligence in scientific business development
Organon PharmaceuticalsDirector, Medical Affairs, Biosimilars
Apr. 2022 - Sep. 2023Here, I worked with the market access and sales teams to develop formulary presentations for regional and national payers while leading discussions with Integrated Delivery Networks (IDNs). I developed and executed high-performing scientific exchange strategies to increase product adoption and revenue while also identifying and addressing education and awareness gaps in the knowledge of key stakeholders regarding our portfolio of drugs and biosimilars. One of my key achievements here was helping the market access and sales team win two major accounts, including one of the largest IDNs in the West. My role here was not just as an SME for scientific exchange but I went above and beyond just providing clinical data and product demonstrations by serving as the connection between the internal teams as well as the accounts to develop rapport and successfully onboard the accounts. My input here resulted in securing the IDNs’ transition from a reference product to biosimilars. Moreover, I developed and executed effective communications and engagement strategies that were based in territory research and data analysis and spoke to the needs of each stakeholder. For this, I proactively identified the needs, concerns, and even desired requirements of customers and employed a multi-pronged approach to ensure each group of stakeholders was included. SELECT ACCOMPLISHMENTS:
- Enhanced product understanding and its usage through extensive education; identified and addresses knowledge gaps for pharmacists, doctors, nurses, and other key HCPs.
- Drove brand recognition efforts and effective evidence generation, education, training, and scientific communication for multiple product launches.
- Fostered active collaboration and communication to ensure strategic alignment and boost productivity.
Ferring PharmaceuticalsSenior Medical Science Liaison
Oct. 2013 - Apr. 2022Onboarded as a Clinical Liaison and promoted to the Senior Medical Science Liaison role to proactively collaborate with key decision makers, such as advanced practice providers and physicians, to relay information about research and disease states. Contributed to 6 studies in various phases of development, including investigator-initiated Phase III-IV studies, to help physicians understand protocols while providing feedback to the organization — using both clinical development and scientific exchange expertise. On the scientific exchange front, I leveraged my subject matter expertise to provide guidance on advanced practice provider constraints across states and health plan management to doctors and nurses through presentations and advisory boards. I delivered educational presentations regarding specific areas of infertility patient care, such as care of the PCOS patient, AMH testing, complementary alternative medicine, and implications of legal and ethical issues in the infertility clinic. Additionally, I presented health economics outcomes research to Ascent GPO and won formulary coverage for Endometrin with Express Scripts covering 80 million lives. My clinical development contributions included assisting the clinical operations team with protocol development to help optimize new drug preparation and delivery devices for ease of use. For this, I gathered essential insights from physicians and patients regarding usage, patient reactions, and outcomes, to deploy a data-backed approach to the project. SELECT ACCOMPLISHMENTS:
- Worked with the clinical development team on pre-clinical, PK, and Phase II studies while also participating in discussions with the FDA.
- Created a survey about Barriers to Nurses performing research in the reproductive endocrinology field and presented an abstract with results at Pacific Coast Reproductive Society meeting.
Experience: publication and medical communications
The Medical Affairs Company (TMAC)Medical Science Professional – Pfizer Molecular Oncology
Apr. 2013 - Oct. 2013In this role, I successfully delivered disease-state-focused presentations on non-small cell lung cancer (NSCLC), specifically highlighting the significance of molecular testing as recommended by the CAP/IASLC/AMP guidelines. My target audiences, included medical oncologists, clinical pathologists, interventional radiologists, pulmonologists, and clinical nurses. Moreover, I fostered collaboration among multidisciplinary teams to establish effective molecular testing protocols. By facilitating discussions and providing valuable insights, I actively contributed to enhancing patient treatment outcomes Furthermore, I proactively educated pathologists and the lung cancer care team on the guidelines for molecular testing, which resulted in increased awareness and improved adherence to best practices in molecular testing. Additionally, I ensured my commitment to maintaining compliance with corporate integrity requirements. This included promptly submitting Adverse Drug events when reported and effectively managing unsolicited medical requests for information. Overall, my expertise in delivering impactful presentations, driving collaborative efforts, and educating healthcare professionals significantly contributed to the advancement of molecular testing and patient care in the field.
Elan PharmaceuticalsClinical Science Liaison
Jun. 2011 - May. 2013Greater Denver AreaAs a Clinical Science Liaison, I educated Key Opinion Leaders (KOLs) in Immunology and Neurology about company product, providing comprehensive updates on safety, prescribing information, and current research initiatives — ensuring that KOLs are well-informed. I played a vital role in ensuring alignment and accuracy in the development of slide decks and communication materials for external stakeholders through active collaboration with cross-functional teams. This collaborative approach resulted in effective and impactful presentations that resonated with our target audience. To foster continuous learning and knowledge sharing within the Science Liaison team, I took the initiative to initiate and moderate the scientific journal club. The platform facilitated in-depth discussions and provided valuable insights, enhancing the scientific acumen of our team members. I also conducted training sessions on prescribing information label updates, equipping the team with the latest knowledge. Additionally, I developed an in-depth understanding of chemotherapeutic agents to further enhance the scientific acumen of the functional strategy team.
Colorado Center for Reproductive MedicinePhysician Liaison & Nurse Practitioner
Jan. 2010 - Jun. 2011Lone Tree, COOver here, I educated OBGYNs, specialty providers, and family practice physicians about the latest advancements in Reproductive Endocrinology, its clinical studies, and treatment protocols. I actively contributed to the development of educational materials and programs tailored for oncologists who referred chemotherapy patients to Assisted Reproductive Technologies, facilitating better patient outcomes. One of my key achievements here was mitigating potential risks, including revenue loss, FDA non-compliance, and center credibility. To this end, I conducted weekly discussions on ethical compliance, legal concerns, and unforeseen lawsuits due to possible patient errors while reducing patient errors. Another essential aspect of my role was supporting patient recruitment for clinical trials. By engaging with patients and healthcare providers, I identified eligible candidates and facilitated their participation in valuable research studies. Moreover, I aided in marketing and sales efforts by reaching out to OBGYNs, strengthening relationships, and increasing patient referrals. I also assisted with vendor selection and negotiation, ensuring optimal partnerships and resources for the organization's operations. To further contribute to the professional development of healthcare providers, I organized two Continuing Medical Education programs. In this capacity, I actively participated in content selection and conducted CME accreditation due diligence, ensuring the highest quality educational experiences. Additionally, I published a quarterly clinical education periodical targeting local OBGYNs, Urologists, and other specialists with an interest in infertility treatment and improving patient care.
Ascend Specialty RX-SXC Health SolutionsClinical Nurse Educator
Feb. 2006 - Nov. 2010Here, I was instrumental in educating healthcare providers on product development and research in Reproductive Endocrinology and Infertility, Oncology, Hematology, and Immunology. By sharing the latest advancements and insights, I empowered healthcare professionals to make more informed decisions in patient care planning, ultimately improving patient outcomes. One of my key contributions was assisting healthcare providers in developing and maintaining in-office patient education programs. By collaborating closely with them, I supported the creation of comprehensive educational initiatives that enhanced patient understanding and engagement in their own care. In addition, I led the development of regional patient support programs specifically designed for infertility patients. This involved working closely with Key Opinion Leaders (KOLs) and non-profit organizations to establish valuable resources and support networks. These programs played a vital role in providing guidance and assistance to patients navigating the challenges of infertility. Furthermore, I also contributed to pharmacy marketing efforts and provided valuable insights to the sales staff while advising on best practices. I helped boost conversion rates and secure consistent revenue growth by leveraging my expertise in understanding the market dynamics and aligning marketing strategies with customer needs.
Center for Human ReproductionNurse Practitioner & Director of Clinical Operations
Mar. 2003 - Jun. 2005Over here, I oversaw the operational activities of the clinic, ensuring smooth and efficient functioning. This encompassed providing HR support by managing crucial aspects such as hiring, onboarding, and training staff. I also took charge of scheduling and right-sizing the team, optimizing resources and promoting operational efficiencies. Collaboration was a key focus throughout my role, as I worked closely with a diverse team of physicians, embryologists, anaesthesiologists, and nurses. By fostering active communication and collaboration, I contributed to a multidisciplinary approach to patient care, promoting seamless coordination and enhancing overall outcomes. Additionally, I maintained compliance with regulatory guidelines, diligently ensuring adherence to FDA guidelines and consistently kept CLIA and CAP certifications up-to-date. By staying abreast of regulatory requirements, I helped create a safe and compliant environment for both patients and staff.
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