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Michele Clarke is listed as Patient Advocacy & Engagement Executive | Leadership | Strategic Planning | Rare Diseases | Collaboration at Self-employed, based in United States. AeroLeads shows a matched LinkedIn profile for Michele Clarke.
Michele Clarke previously worked as Advocacy and Engagement Consultant, Rare Diseases at Self-Employed and Vice President of Patient Advocacy and Engagement at Passage Bio. Michele Clarke holds Bachelor'S Degree, Dual Major Psychology And Sociology from Suny Geneseo.
Accomplished executive with over 15 years of experience delivering meaningful outcomes for patients and innovative companies by creating authentic partnerships with patients, advocacy organizations, and key stakeholders to define unmet needs and inform critical business decisions from drug development through commercialization. Skilled at building, leading, and developing high-performing global teams. I am passionate about building partnerships with patients, advocates, KOLs, and internal colleagues built on trust and transparency that deliver tangible value. Expertise in strategic planning and execution, cross-functional and external collaborations, communication, and leadership. I possess a strong clinical acumen in gene therapy, rare diseases, neurology, oncology, hematology, cardiology, and metabolic disorders. I have successfully launched over 15 commercial products in oncology, hematology, neurology, cardiometabolic, and rare disease, including 2 ultra-rare disease therapies. I have also championed patient-centric drug development for 6 investigational therapeutic programs in rare diseases.Core Competencies:Patient Advocacy & Engagement | KOL Engagement | Leadership | Strategic Planning & Execution | Product Launch Drug Development | Cross-functional Collaboration | Budgeting & Forecasting | Rare Disease Clinical Trials Global Engagement Compliance Operations | National Account Management | Startups
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Consultant/contractor providing life science companies with strategic guidance on patient and professional advocacy and engagement strategies.
Philadelphia, Pennsylvania, Us
Promoted to build and lead a best-in-class Patient Advocacy and Engagement Team to support pediatric and adult rare neurodegenerative disease communities.- Developed patient advocacy framework, roadmap, and strategies for rare disease assets in various phases of drug development to incorporate the patient voice into critical business decisions cross-functionally.- Recruited, developed, and empowered a high-performing patient advocacy team to operate with excellence and integrity through times of ambiguity and change.- Drove global initiatives supporting disease awareness, clinical trial education, gene therapy education, and community engagement.- Built authentic partnerships with advocacy groups, professional organizations, and internal and external stakeholders, fostering transparency and trust.- Partnered with advocacy organizations to advance policy initiatives supporting early diagnosis, health equity, and access to treatment.- Ensured global compliance in all patient interactions, communications, data management, and processes.- Developed disease and clinical trial education tools in multiple languages to support US and international patients.- Partnered with advocacy groups and industry stakeholders to support the advancement of newborn screening. Member of 4 external NBS task forces.- Established Patient and Caregiver Councils, Global Patient and Caregiver Advisory Boards, and focus groups to capture patient and caregiver insights, diagnostic journeys, and experiences.- Oversaw budget and annual forecasting, advocacy grants and sponsorships, and agency and vendor management.- Supported cross-functional collaboration through consistent, proactive communication.
Philadelphia, Pennsylvania, Us
Recruited by CEO to establish patient advocacy and engagement function, budget, and infrastructure for pre-clinical gene therapy startup focused on rare pediatric and adult neurological diseases in alignment with corporate strategies, values, and culture. Created authentic partnerships between the company and the communities we served.- Raised awareness and engagement among patient communities by spearheading the development and execution of patient advocacy strategies for preclinical and clinical stage gene therapy programs in rare neurological diseases. - Identified, collaborated with, and built partnerships with patient, professional, and umbrella advocacy groups to ensure corporate strategies aligned with the unmet needs of rare disease communities.- Engaged and motivated employees across all business functions in the organization's vision and mission by creating initiatives that connect employees with patient and caregiver/carer communities
Mumbai, Maharastra, In
One of 4 hires recruited to spearhead the commercial launch of the company's US Branded Oncology Division.- Supported national contracting with oncology and urology GPOs.- Led KOL engagement, patient identification, and education in the Northeast US.- Optimized patient access and onboarding process, facilitating improved patient outcomes and experiences.
Recruited to transform compliance environment for patient and professional engagement globally. Led a team of 9 managers to develop and implement systems and processes to ensure US and international regulatory compliance.- Brought the organization into compliance ahead of an aggressive 3-month timeline by leading process and system development, cross-functional training, and change management initiatives.- partnered with external vendors to ensure successful audits.- Recognized for outstanding leadership with 7 Excellence Awards.- Led integration of newly acquired companies into improved patient and professional engagement processes.- Collaborated with Medical, Legal, Compliance, Regulatory, Patient Advocacy, Sales & Marketing, and external agencies and vendors.
Boston, Us
- Managed pre-launch and post-launch clinical education for ultra-rare disease HoFH to improve accurate and timely diagnosis and appropriate patient selection for treatment.- Partnered with patients, caregivers, payors, KOLs, and key stakeholders to support access to treatment and improve patient experiences.- Developed national advisory board program.- Educated patients and families on therapy adherence and complex dietary requirements to support treatment success.
Boston, Massachusetts, Us
Promoted to spearhead national initiatives for a startup rare disease biotech company to educate and activate physicians and patients. Managed National Oncology and Hematology networks supporting improved diagnosis, education, and treatment of patients with ultra-rare hematological disease, Paroxysmal Nocturnal Hemoglobinuria (PNH).- Spearheaded diagnostic pathway project with US Oncology/McKesson involving 3K+ oncologists and 850K patients, setting a precedent for adoption in regional IDNs and national oncology practices.- Developed and executed US marketing programs, including advisory boards, speaker programs, and speaker contracting.
Boston, Massachusetts, Us
Promoted to recruit, develop, and lead a team of 11 high-performing hematology /oncology managers in the Northeast US.- Created and implemented early patient identification/diagnostics programs to significantly reduce the complexity and length of the diagnostic journey.- Partnered with national labs to enhance the accuracy and availability of testing for PNH.- Selected to train LATAM and Canada country managers
Boston, Massachusetts, Us
Recruited by CEO as the #2 commercial hire, responsible for pre-launch market development, KOL education, and launch of biologic treatment for patients with the ultra-orphan disease paroxysmal nocturnal hemoglobinuria (PNH).
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Michele Clarke works for Self-employed.
Michele Clarke is listed as Patient Advocacy & Engagement Executive | Leadership | Strategic Planning | Rare Diseases | Collaboration at Self-employed.
Michele Clarke is based in United States while working with Self-employed.
Michele Clarke has worked for Self-Employed, Passage Bio, Sun Pharma, Takeda (Shire), and Novelion Therapeutics.
You can use AeroLeads to view verified contact signals for Michele Clarke at Self-employed, including work email, phone, and LinkedIn data when available.
Michele Clarke holds Bachelor'S Degree, Dual Major Psychology And Sociology from Suny Geneseo.
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