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Mimi Lin Park is listed as Director, Development Project Management at Rigel Pharmaceuticals Inc. at Rigel Pharmaceuticals Inc., based in Redwood City, California, United States. AeroLeads shows a matched LinkedIn profile for Mimi Lin Park.
Mimi Lin Park previously worked as Director, Development Project Management at Rigel Pharmaceuticals Inc. and Director of Program Management at Cymabay Therapeutics. Mimi Lin Park holds B.S., Chemistry from University Of California, Davis.
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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.
Listed skills include Pharmaceutical Industry, Technology Transfer, Biotechnology, Fda, and 21 others.
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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.
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
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.
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.
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
Fremont, Ca, Us
Development of microarray transdermal products
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.
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.
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.
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).
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Mimi Lin Park works for Rigel Pharmaceuticals Inc..
Mimi Lin Park is listed as Director, Development Project Management at Rigel Pharmaceuticals Inc. at Rigel Pharmaceuticals Inc..
Mimi Lin Park is based in Redwood City, California, United States while working with Rigel Pharmaceuticals Inc..
Mimi Lin Park has worked for Rigel Pharmaceuticals Inc., Cymabay Therapeutics, Iovance Biotherapeutics, Inc., Novartis, and Independent Consultant.
You can use AeroLeads to view verified contact signals for Mimi Lin Park at Rigel Pharmaceuticals Inc., including work email, phone, and LinkedIn data when available.
Mimi Lin Park holds B.S., Chemistry from University Of California, Davis.
Mimi Lin Park is listed with skills including Pharmaceutical Industry, Technology Transfer, Biotechnology, Fda, Drug Development, Gmp, Validation, and Clinical Trials.
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