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Extensive clinical research, scientific affairs and regulatory experience through all phases of clinical development, including rare disease/orphan expertise. Leadership of development teams resulting in multiple NDAs, FDA Advisory Committees, label negotiations and global product approvals. Proven ability to lead departments, cross functional teams, consultants and vendors to establish clear project strategic plans and achieve or exceed planned product milestones. Ability to critically evaluate new data, pragmatically confirming or adjusting plans to support the intended outcome. Solution-oriented with aptitude to inspire others through attributes of enthusiasm, authenticity, collaboration, knowledge and respect. Demonstrated success in corporate partner and Board of Director interactions. Proficiency in therapeutic areas of diabetes, cardiovascular, obesity and other metabolic disorders.
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Svp, DevelopmentProlynxSan Diego, Ca, Us -
Founder And Principal ConsultantKt Development Solutions Sep 2024 - Present
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Senior Vice President And Head Of Clinical DevelopmentEscient Pharmaceuticals Jul 2021 - Sep 2024San Diego, Ca, UsLead global clinical development of Escient’s portfolio of mas-related GPCR (MRGPR) antagonists:• Cross functional development team lead for all programs. Responsible for leading the team in establishing the development plan (nonclinical, CMC, clinical) and networking with executive management/BoD• Escient point of contact with FDA and other regulatory authorities. Key strategist for timing and content of all communications (briefing books, responses to information requests, IND submissions, pursuit of waivers/deferrals, in person and teleconference discussions). Also responsible for regulatory operations• Built the clinical (clinical science, clinical operations, clinical pharmacology), biometrics, safety, regulatory, quality and program management teams utilizing a blend of internal and contract resources to meet corporate resource strategy plans• Responsible for development and implementation of all Scientific Affairs activities, including KOL relations, advisory boards, scientific conference presentations and publication plans• Key participant in product development discussions with the BoD, investors and potential stakeholders• Established comprehensive development plans for MRGPRX4 and MRGPRX2 antagonists with detailed tactics for implementation. Responsible for all aspects of clinical study design, implementation, analysis, and interpretation of results. Target indications include cholestatic pruritus in rare disease, chronic urticaria and atopic dermatitis -
Vice President And Head Of Clinical DevelopmentEscient Pharmaceuticals Jul 2019 - Jul 2021San Diego, Ca, Us -
Vice President/Head Of Clinical Development And San Diego Site HeadZafgen, Inc. Aug 2014 - Jul 2019Lead global clinical development of Zafgen’s portfolio of MetAP2 inhibitors across all phases of development.• Built and maintained a clinical team utilizing a blend of internal and contract resources to meet corporate resource strategy plans. The clinical development department at Zafgen encompasses scientific functions (clinical science, medical affairs, biostatistics and programming), clinical operations, medical writing, data management, medical monitoring and clinical safety• Key strategist for all clinical communications (briefing books, responses to information requests, IND submissions, pursuit of waivers/deferrals, in person and teleconference discussions) to FDA and other regulatory authorities• Accountable for clinical plan development. Responsible for all aspects of study design, implementation, analysis, and interpretation of results. Primary clinical development plans have included: o beloranib for treatment of Prader-Willi Syndrome (orphan designation) o beloranib for treatment of hypothalamic injury-induced obesity (orphan designation) o ZGN-1061 for treatment of type 2 diabetes• Strategically contribute to development and implementation of all Scientific Affairs activities, including KOL relations, advisory boards, and publication plans• Evaluate and/or represent clinical data for all business development opportunities• Represent the clinical department at all management forums, including the scientific subcommittee of the Board of DirectorsSite Head Management responsibility for satellite San Diego office
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Vice President/Head, Clinical DevelopmentOrexigen Therapeutics Jan 2013 - Aug 2014La Jolla, Ca, UsLead the clinical development department for development of Contrave®/Mysimba®, a first in class fixed-dose combination product for the treatment of obesity. The department was also responsible for the development of Empatic™, a Phase 2 fixed-dose combination asset for the treatment of obesity.• The clinical development department encompassed clinical science, clinical pharmacology, statistics/programming, data management and medical writing functions with scope supporting development, regulatory, investor relations and commercial activities for Orexigen’s product candidates• Led Contrave Advisory Committee preparation activities that resulted in the first positive Committee recommendation for an obesity drug approval in 13 years• Key strategist for all aspects of FDA and European regulatory interactions, including NDA process, formal FDA dispute resolution (FDRR), European Scientific Advice• Serve on governance committees for the Orexigen-Takeda corporate partnership• Establish development plans for Contrave and Empatic with detailed tactics for implementation. Responsible for all aspects of study design, implementation, analysis, and interpretation of results• Responsible for clinical evaluation of in-licensing opportunities• Scientific lead for evaluation and selection of partners and options for behavioral modification programs to be used in combination with Contrave• Responsible for development and implementation of all Scientific Affairs activities, including KOL development, advisory boards, and publication plan -
Senior Director, Clinical DevelopmentOrexigen Therapeutics May 2010 - Jan 2013La Jolla, Ca, Us -
Senior Director, Medical ResearchAmylin Pharmaceuticals 2007 - May 2010San Diego, Ca, UsLead the clinical science department, responsible for providing broad scientific direction to all Amylin development projects including SYMLIN®, a first in class product for treatment of diabetes, BYETTA®, a first in class product for treatment of diabetes, BYDUREON®, an extended-release form of Byetta, and other pipeline projects. Served as clinical development team lead for Byetta through Phase 4 and for Bydureon through Phase 3B.• Oversee department of clinical scientists, clinical pharmacologists and physicians with responsibilities spanning from clinical development through medical affairs• Principle conduit of clinical information to and from corporate partners, Eli Lilly and Alkermes. Lead cross-partner clinical development teams• Accountable for strategic cross-functional development of clinical plans for all projects. Developed sustainable tools for documentation and broad communication of clinical plans• Provide oversight to all aspects of study design, implementation, analysis, and interpretation of results Primary clinical contributor to the NDA submissions for Byetta and Bydureon. Responsible for leading the NDA submission clinical teams (both content and operations) and supervision of personnel leading sNDA submission clinical teams• Accountable for clinical preparation of briefing documents and presentation materials for FDA meetings. Contribute to interactions with European regulatory authorities• Represent clinical development at advisory boards; establish relationships with key opinion leaders -
Director, Clinical ScienceAmylin Pharmaceuticals 2007 - 2009San Diego, Ca, Us -
Associate Director, Clinical ScienceAmylin Pharmaceuticals 2005 - 2007San Diego, Ca, Us -
Senior Manager, Clinical ScienceAmylin Pharmaceuticals 2003 - 2004San Diego, Ca, Us -
Manager, Clinical ScienceAmylin Pharmaceuticals 2003 - 2003San Diego, Ca, Us -
Clinical ScientistAmylin Pharmaceuticals 2001 - 2002San Diego, Ca, Us -
Research ScientistGen Probe 2000 - 2001Ca, 92121, UsLiaise between Research and Development, Regulatory Affairs, and Quality Assurance groups in the preparation of documents for Biologic License Applications and Investigative New Drug Applications• Prepare scientific manuscripts and facilitate abstract acceptance for professional meetings• Gen-Probe Award of Excellence, January 2001
Kristin Taylor Education Details
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Uc San DiegoPostdoctoral Fellowship -
Medical College Of Pennsylvania,Now Part Of Drexel University College Of MedicineBiochemistry -
University Of VirginiaBiochemistry
Frequently Asked Questions about Kristin Taylor
What company does Kristin Taylor work for?
Kristin Taylor works for Prolynx
What is Kristin Taylor's role at the current company?
Kristin Taylor's current role is SVP, Development.
What is Kristin Taylor's email address?
Kristin Taylor's email address is kr****@****hoo.com
What schools did Kristin Taylor attend?
Kristin Taylor attended Uc San Diego, Medical College Of Pennsylvania,now Part Of Drexel University College Of Medicine, University Of Virginia.
Who are Kristin Taylor's colleagues?
Kristin Taylor's colleagues are Guillermo Hails, Rocío Del Valle Fernández, Eric Schneider, Gedo Mohamed, Gary Ashley.
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