William Hahne, Md Email and Phone Number
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SENIOR INDUSTRY PHYSICIANOncology | Hematology | Gastroenterology | Anti-infectives | CNS | Anesthesiology | NeurologyInnovative and collaborative Scientific Executive who consistently delivers on the critical responsibility of translating pharmacological actions of drugs into FDA approvals.Leader of project teams of up to 50 through direct or matrixed reporting relationships. Has an extensive network of key thought leaders in a number of therapeutic areas.Persuasive communication skills that facilitate collaborative teamwork, build alliances and bring successful outcomes.Multiple IND and new chemical entity applications and approvals, including International experience (Europe, Canada, Australia, Japan).
Cymabay Therapeutics
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Medical ConsultantCymabay Therapeutics Aug 2023 - PresentNewark, California, Us
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Clinical Research ConsultantSelf-Employed Sep 2019 - Present
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Vice President Clinical ResearchSelf-Employed Apr 2017 - PresentResponsible for day-to-day operations for all areas of the Company's clinical programs including management of clinical staff, reporting, budget performance as well as other key responsibilities. Additionally, you will work with the executive leadership team in developing and executing the Company's clinical strategic plan.
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Available For Clinical Research ConsultingSelf Employed Apr 2024 - Aug 2024Satellite Beach, Florida, Us -
Medical ConsultantVoisin Consulting Life Sciences (Vcls) Sep 2016 - Mar 2017Paris, Paris, FrAssist with BLA review for USA -
Medical ConsultantMedimmune Jul 2016 - Sep 2016Gaithersburg, Maryland, UsAssist with Medical review for durvalumab BLA components. -
Contract Medical DirectorLion Biotechnologies, Inc. Mar 2016 - Jun 2016My responsibilities include helping the CMO start and execute clinical studies
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Medical ConsultantSeattle Genetics 2015 - 2016Bothell, Washington, Us● Contract Medical Director for a novel Antibody Drug Conjugate for the treatment of Lymphoblastic Leukemia.● Provided medical oversight for large Phase I study, including data review, efficacy and adverse event assessment and presentation preparation. -
Consultant CmoAminex Therapeutics 2014 - 2015Us● Provided pre IND consultation and strategy for a unique combination product for oncology patients. -
ConsultantTherakos, Inc. 2013 - 2014● Assisted VP Clinical Research with expanding US-approved Drug Device for CTCL to other countries (Israel)
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Medical ConsultantCelgene Cellular Therapeutics 2012 - 2013Summit, New Jersey, Us● Led an internal team to get a key IND (corporate priority) to FDA on time through 14 days of blackout following Hurricane Sandy. Phase I successful. Phase II started in late 2014. ● Performed due diligence for a potential in-licensed product. -
Medical ConsultantAmag Pharmaceuticals 2012 - 2012Waltham, Ma, Us● Collaborated with CMO in the clinical execution of study reports on ferumoxytol for iron deficiency anemia (IDA). ● Worked with clinical research, pharmacovigilance, clinical operations, project management, and regulatory areas during this contract which was completed in April. -
Vice President, Clinical ResearchCelator Pharmaceuticals 2010 - 2011● As VP of clinical research, provided medical oversight for CPX-351.● Succeeded with three successful FDA meetings and acquired EMA experience in scientific advice and orphan designation.
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Vice President, Medical AffairsVion Pharmaceuticals Feb 2008 - Dec 2009Us● Corporate officer who reported to the CEO of this 40-person firm.● Medical responsibility (post clinical trial execution) for NDA (eCTD) submissions, safety summaries, report writing, clinical pharmacology.● Medical aspects of ODAC preparation.● Established a separate pharmacovigilance department and designated a professional to handle safety full-time -
Vp, Clinical Development & Medical AffairsCelsion Corporation 2006 - 2007Us● Managed all aspects of clinical development conducted in U.S. for liposomal drug-device combination (ThermoDox®) to be used in liver and breast cancer as head of Clinical and then as Head of R&D. -
Vp, Clinical DevelopmentCuragen Corporation 2003 - 2005Us● Advanced clinical portfolio development in biologics, based on Curagen work on the human genome.● Collaborated and published with the preclinical team to establish core program for targeted monoclonal therapies. ● Grew clinical department from one to eight associates, building collaborative, matrix-managed study teams committed to increasing productivity and improving quality. -
Head, Gastroenterology Franchise & Vp-Clinical Research & DevelopmentEisai Inc. 1997 - 2002Us● Supervised all clinical research conducted in U.S. (as Executive Director, then VP Clinical Research and Development) with budget of $70 Million and 70 clinical employees. ● Chaired joint development committees for Aricept® with Pfizer and Aciphex® with Johnson & Johnson as global team leader driving co-promotion initiatives. that led to approval of Pariet/Aciphex®,● Created and oversaw four therapeutic areas: GI/Oncology, CNS, Anti-Infectives, and Medical Affairs.● Supervised Multiple INDs. -
Product Team Director, Clinical ResearchHoescht Marion Roussel, Inc. 1989 - 1997● Led the Global clinical team to success with submitted INDs, and approved NDAs and MAAs for Anzemet® IV and oral.● Played a pivotal transition committee role between Merrill Dow to MMD integrating MMD, Anzemet® and Allegra® teams.
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Assistant And Associate Director, Clinical DevelopmentGlaxo Inc. 1986 - 1989● Constructed IB, clinical protocols and submitted the original IND in 1986 for the breakthrough product, Zofran®.● Wrote Phase II summaries for EMEA submission of Zofran® MAA.● Wrote and submitted and important supplemental approved FDA submission for Zantac Injection® (Contiguous Infusion Ranitidine)
William Hahne, Md Skills
William Hahne, Md Education Details
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Joan & Sanford I. Weill Medical College Of Cornell UniversityMedicine -
Grinnell CollegeChemistry
Frequently Asked Questions about William Hahne, Md
What company does William Hahne, Md work for?
William Hahne, Md works for Cymabay Therapeutics
What is William Hahne, Md's role at the current company?
William Hahne, Md's current role is Clinical Research Consultant, Self-employed. Very experienced at remote work..
What is William Hahne, Md's email address?
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What is William Hahne, Md's direct phone number?
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What schools did William Hahne, Md attend?
William Hahne, Md attended Joan & Sanford I. Weill Medical College Of Cornell University, Grinnell College.
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William Hahne, Md has interest in Health.
What skills is William Hahne, Md known for?
William Hahne, Md has skills like Drug Development, Clinical Development, Biotechnology, Pharmaceutical Industry, Oncology, Clinical Research, Fda, Clinical Trials, Lifesciences, Biomarkers, Medical Affairs, Ind.
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