Hitesh Muley

About Hitesh Muley

In my current role, I serve as the Medical Lead for Rare Diseases, and working on Field Medical effectiveness at Pfizer in India. With over seven years at Pfizer and more than 11 years of professional experience, I\'ve successfully built and led the rare disease medical team for areas such as Hemophilia, Growth hormone disorders, and rare cardiovascular therapies. I\'ve provided strategic medical guidance for various therapeutic areas, including Internal Medicine, Gastrointestinal, and Pain & Inflammation. During my tenure, I took decisive medical leadership, successfully launching new products (VyndaMx, BeneFIX, Neksium, Neksium D), shaping innovative therapy areas like ATTR-CM, and contributing significantly with advocacy for rare disease policy shaping and scientific external partnerships. My expertise spans Bioavailability and Bioequivalence studies, Clinical research, Pharmacovigilance, Regulatory affairs, and medical writing. Having faced and overcome various challenges, I\'ve developed both personally and guided my team effectively. With a robust technical background and extensive experience, I am well-equipped to lead, taking on responsibilities confidently in this new role.

Experience

1. Medical Lead Rare Disease, Field Medical, India

   화이자

   Nov 2019 — Present

   ATTR CM Therapy Area Shaping and Launch of VyndaMx: Establish 30+ ATTR CM Center of excellence across India with referral network around it and build the complete ecosystem for early & x without customer facing colleague. Implemented diagnostic support program, Public awareness and media campaign and Established India ATTR CM expert group that prepared India Specific Consensus document Genryzon Launch (Long Acting Growth Hormone) Planned and successfully executed Somatrogon launch, First long acting Growth hormone in India by cocreating medical launch strategy and scientific communication plan with the teamShaping National Policy for Rare diseases of India: Insight based, multi-stakeholder Rare Disease policy shaping, voicing the true voice rare disease patient resulted inrecommendation finding place in National Policy for Rare Disease of India opened way to improve life of rare disease patient with new medicines and increase funding Provision Participated at roundtable Multi stakeholder Discussion on NPRD, at Delhi organized by industry network OPPI and PPHF and lead the discussion for unified recommendation for Ministry of Health and family welfare resulting in multistakeholder single recommendation letter for MOHFW Collaborate with ORDI (Organization for Rare Diseases of India) to conduct RD patient FGD gathered patients insight and expectation form govt and Industry and incorporated the Patient voice in the recommendations BeneFix (Nonacog Alfa) launch: Provided medical leadership for the successful launch of BeneFIX (Nonacog alfa, recombinant coagulation factor IX) in India for managing bleeding in hemophilia B patients, and later spearheaded efforts to secure approval for once-a-week dosing in India

Education

• Seth Bansidhar Highschool telhara.Dist Akola Maharashtra

  SSC

• RLT science college akola Maharashtra

  Junoir college, Science

  1999 — 2001

• MGM University of health science

  Doctor of Medicine (M.D.), Pharmacology

  2010 — 2013

Skills

• Pharmaceutical Industry
• Sop
• Fda
• Gynacology
• Marketing Communications
• Gmp
• Training
• Project Management
• Customer Service
• Diabetes
• Biotechnology
• Regularatory Affairs
• Cross-Functional Team Leadership
• Quality Assurance
• Clinical Research
• Cardiology
• Antibiotics
• Medical Education
• Clinical Cardiology
• Gastroenterology
• Research
• Clinical Medical Regulatory
• Market Research
• Medical Advisor,
• Regulatory Affairs
• Pharmacology
• Oncology
• Womens Health Care
• Management