Mimi Lin Park

Mimi Lin Park Email and Phone Number

Director, Development Project Management at Rigel Pharmaceuticals Inc. @ Rigel Pharmaceuticals Inc.
Mimi Lin Park's Location
Redwood City, California, United States, United States
Mimi Lin Park's Contact Details

Mimi Lin Park personal email

About Mimi Lin Park

20+ years in pharmaceutical development project management with hands-on experience with cross-functional departments in a matrix organization: research, preclinical, clinical, manufacturing, regulatory, and marketing.o Treatment areas: PBC, NASH, PSC, NCFBE, COPD, Oncology, CNS/Pain, Veterinaryo Drug delivery platforms: oral, inhalation, implant, transdermal, liposomesI have 1st hand experience being the PM through Director PM on development teams in the following stages. This includes a variety of compounds in different therapeutic areas.o Preclinical: tracking of PK, PD, tox reports to support IND o Manufacturing for Ph I, II a/b, registration stability lots, III, IVo Clinical study set-up, execution, budgets: Ph I, II a/b, IIIo Packaging, stability, labelling & distributiono PM experience both in managing CMOs and operating as a CMOo Transitions from R&D to Commercial manufacturing facilitieso Full NDA submission/approval/launch (Viadur™ product, an implantable oncology device) and a CMC submission (partner program)o Transitioning distribution of commercial products to Special Pharma Distribution modelo Divestiture of projects including alliance management to ensure smooth transitiono Portfolio management of programsHighly experienced in managing business and technical requirements to meet strategic needs with key business stakeholders. Significant alliance management experience for global product development.o Financial responsibility for multiple projects within a product commercialization PMO.o Successfully led projects up to 300MM dollars and 100+ FTEo Capable of seeing and understanding the “big picture” to determine strategic goals based on customer and consumer needs. Follow with focus on team execution of smaller goals. Effective risk management planning based on Go/NoGo data-driven criteria, mitigation plans and trigger points.o Able to understand the technical aspects of products & processes, and hence able to constructively communicate with technical personnel.

Mimi Lin Park's Current Company Details
Rigel Pharmaceuticals Inc.

Rigel Pharmaceuticals Inc.

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Director, Development Project Management at Rigel Pharmaceuticals Inc.
Mimi Lin Park Work Experience Details
  • Rigel Pharmaceuticals Inc.
    Director, Development Project Management
    Rigel Pharmaceuticals Inc. May 2020 - Present
    South San Francisco, Ca, Us
    Responsible for driving and coordinating cross-functional activities required to advance multiple programs from non-clinical development through regulatory submission. Contributes to the establishment and execution of program strategy and activities, integrating cross-functional input, synthesizing team recommendations, and directing program advancement on time and on budget.
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  • Cymabay Therapeutics
    Director Of Program Management
    Cymabay Therapeutics Feb 2018 - Jan 2020
    Newark, California, Us
    • Leader of cross-functional teams with a focus in overcoming barriers to achieve deliverables for Seladelpar program (3 indications; PBC, NASH, PSC). Executed portfolio management and integration of internal/external (vendor) timelines for 12+ clinical studies (Ph 1, 2 & 3) focused on planning for NDA submission. Oversight of CMC development activities.• Developed and implemented project management processes, tools and methodologies for development; 3-yr resource forecasting, budget planning, status reporting and ad hoc projects
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  • Iovance Biotherapeutics, Inc.
    Director Of Program Management
    Iovance Biotherapeutics, Inc. Mar 2017 - Oct 2017
    San Carlos, California, Us
    • Development of cancer immunotherapies based on tumor infiltrating lymphocytes (TILs) in stages of pre-IND through BLA• PM between internal team and external vendor for automation of clinical and commercial supplies.
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  • Novartis
    Director, Program Management
    Novartis Jul 2014 - Jan 2017
    Basel, Baselstadt, Ch
    • Lead analysis and reporting of site program portfolio.• Lead the program budget planning process through work plan preparation and maintenance, ensuring the client understands program risks. • Lead TRD subteams, and in partnership with technical lead, formulate a scientifically sound and business driven TRD project strategy including contingency planning and risk assessments as appropriate and in line with overall GPT/PoC team project strategy, involving departmental project leaders and/or functional experts.
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  • Independent Consultant
    Project Management Independent Consultant
    Independent Consultant Apr 2010 - May 2014
    Provide project management expertise to companies on based on the needs of the organizations. Areas include Strategic Planning, Business Process, Clinical, CMC and Regulatory Planning for pharmaceutical development.- Genentech: Commercial Project Manager- Keryx: Director, Project Management- Proprietary Company: Clinical Development- Zosano Pharmaceuticals: Director, Project Management- Kindred Biosciences, Project Management
  • Zosano Pharma
    Director, Project Manager
    Zosano Pharma Jul 2013 - Jan 2014
    Fremont, Ca, Us
    Development of microarray transdermal products
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  • Keryx Biopharmaceuticals
    Project Management Consultant, Oncology
    Keryx Biopharmaceuticals Jul 2005 - Apr 2010
    Program & Project Manager for development of 2 oncology programs.* Project #1: 25 Phase I and II clinical studies ongoing simultaneously. Managed in-house project resources.* Project #2: 2 Phase I and II clinical studies. Managed CRO hired to conduct studies.* Site management, contracts, protocols, IRB communications, and data management reviews.*Overall management and author for 8 FDA Annual Reports and 4 FDA briefing books for meetings with FDA.* Implementation of strategic plan with Core Team.
  • Alza / Johnson & Johnson
    Sr. Program Manager
    Alza / Johnson & Johnson 1998 - 2004
    New Brunswick, Nj, Us
    * Lead the project team to define the critical path activities that ensure the most efficient route to approval in countries of interest, while maximizing the product’s global commercial potential.* Responsible for NDA & MAA Submission & Approval of Viadur® leuprolide acetate implant* Provide timely, accurate communication of key project issues/events to senior management at ALZA and J&J. Serve as project spokesperson on development issues.* Financial responsibility for projects under my direction managing projects up to 300MM dollars and 100+ FTE.* Project Leadership for the following pharmaceutical delivery platforms: transdermal, oral, implantable, and liposomal injection.* Project Leadership in the following therapeutic areas: chronic pain, CNS, oncology.
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  • Raychem Part Of Tyco Electronics And Tyco International
    Co-Project Manager, Product Development (Display Products Group)
    Raychem Part Of Tyco Electronics And Tyco International Oct 1995 - May 1998
    Ch-8200 Schaffhausen, Ch
    * Responsible for commercial scale, liquid crystal development for Projector Displays. Areas of development included: chemical reaction kinetics, reactor optimization, and process controls.* Responsible for designing and scheduling development experiments, meeting liquid crystal production requirements for US and Japan, and for allocating appropriate resources.
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  • Cygnus Therapeutics
    Chemist
    Cygnus Therapeutics 1991 - 1995
    Scientist, Drug Delivery Product Development* Controlled release drug development and formulations research* Manufacturing of Phase I/II clinical supplies for 3 products under GMP/GLP conditions.* Significant contributions to DMF and Investigational New Drug (IND) Applications (3 products).

Mimi Lin Park Skills

Pharmaceutical Industry Technology Transfer Biotechnology Fda Drug Development Gmp Validation Clinical Trials Medical Devices Sop Clinical Development Lifesciences Oncology Change Control Ind Pharmaceutics Protocol Biopharmaceuticals Strategy Cro Therapeutic Areas U.s. Food And Drug Administration Cro Management Cross Functional Team Leadership Life Sciences

Mimi Lin Park Education Details

  • University Of California, Davis
    University Of California, Davis
    Chemistry

Frequently Asked Questions about Mimi Lin Park

What company does Mimi Lin Park work for?

Mimi Lin Park works for Rigel Pharmaceuticals Inc.

What is Mimi Lin Park's role at the current company?

Mimi Lin Park's current role is Director, Development Project Management at Rigel Pharmaceuticals Inc..

What is Mimi Lin Park's email address?

Mimi Lin Park's email address is pa****@****hoo.com

What schools did Mimi Lin Park attend?

Mimi Lin Park attended University Of California, Davis.

What skills is Mimi Lin Park known for?

Mimi Lin Park has skills like Pharmaceutical Industry, Technology Transfer, Biotechnology, Fda, Drug Development, Gmp, Validation, Clinical Trials, Medical Devices, Sop, Clinical Development, Lifesciences.

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