Summary
Overview
Work History
Education
Skills
Additional Career Experiences - Available Upon Request
References
Timeline
Receptionist

Michelle Frank

San Diego,CA

Summary

PMP-certified drug development professional with 30 years of biopharma experience, specializing in results-driven strategies from ideation to commercialization. Demonstrates expertise in drug discovery, clinical development, program operations, medical affairs and global marketing authorization filings, complemented by a strong focus on organizational change management and continuous improvement. Proven ability to align cross-functional teams and enhance productivity while navigating complex regulatory landscapes. Committed to fostering high-performing teams that achieve successful product launches and drive revenue growth.

Overview

16
16
years of professional experience

Work History

Project Management Consultant

Soleno Therapeutics
Redwood City, CA
12.2024 - Current
  • Offering strategic project management and operational excellence consulting to the Chief Development Officer and the Development Leadership Team.
  • Lead Development Leadership and Operations Team meetings, providing structured agendas and comprehensive minutes.
  • Implement project timelines and manage team meetings for Clinical Development New Indications and Life Cycle Management teams, ensuring efficient workflow.
  • Lead the project management efforts for the EMA marketing authorization application (MAA) of DCCR (Diazoxide Choline) Extended-Release tablets for the treatment of Prader-Willi syndrome (PWS).
  • Established a communication and decision-making framework to boost transparency, accountability, and executive visibility on project status.
  • Partner with Finance to facilitate annual operational planning, aligning resources and budgets within and across departments.

Executive Director, Medical Affairs Strategy & Ops

Axsome Therapeutics
New York, NY
07.2023 - 06.2024
  • Led strategic and tactical planning and execution across Medical Affairs functions, ensuring consistent best practices.
  • Worked with Finance to direct budgeting, forecasting (LRP), accruals, and headcount planning, including the identification of new Medical Affairs Budget Expense Types for accurate budgeting.
  • Partnered with the SVP Quality to assign appropriate GxP training to Medical Affairs, ensuring compliance and inspection readiness.
  • Oversaw the development and implementation of Medical Affairs SOPs, policies, and best practices to maintain regulatory compliance.
  • Collaborated with the Executive Vice President, Product Strategy to formulate Medical Affairs strategies and objectives for Launch Readiness Planning for pipeline indications.
  • Partnered with cross-functional teams to align congress planning and execution with overall Medical Affairs objectives.
  • Analyzed operational processes and performance to identify gaps and recommend solutions, including the implementation of PubsHub, RightFind, and CyberGrants.
  • Provided comprehensive purchase order and contract support for the Medical Affairs Department, including managing consulting agreements.
  • Partnered with IT and Functional Leads to design and implement the Medical Affairs website.
  • Developed a comprehensive publications timeline and slide deck to support Scientific Communications in executing their Publication Strategy.

Director, Medical Affairs Operations

Acadia Pharmaceuticals
San Diego, CA
05.2020 - 07.2023
  • Oversaw the execution of all Medical Affairs operational needs, ensuring alignment with department and corporate goals.
  • Conducted comprehensive assessments of Medical Affairs capabilities, processes, and systems to identify gaps and opportunities for improvement.
  • Partnered with Compliance to lead Inspection Readiness for the Medical Affairs Department, including CAPA management, SOPs, Controlled Documents, and Policies.
  • Managed the development and execution of Medical Affairs strategies, ensuring budget compliance and alignment with Brand Plans to achieve Corporate Goals.
  • Developed and tracked timelines for Phase 4 Real World Evidence and Non-Interventional Studies.
  • Partnered with Medical Affairs Leadership Team to establish and track critical launch milestones for DAYBUE in the treatment of Rett Syndrome.
  • Coordinated Advisory Board meetings with Healthcare Providers and Caregivers, including the development of an asynchronous Advisory Board and Caregivers Roundtable for Rett Syndrome.
  • Provided comprehensive meeting management and facilitation support to advance strategic projects in line with corporate and department objectives.
  • Established and communicated program status through monthly dashboards and reporting materials, proactively identifying issues and delays.
  • Provided comprehensive mentoring and line management to the Medical Affairs Project Coordinator, ensuring their professional growth.

Director, Program Management

Heron Therapeutics
San Diego, CA
02.2018 - 04.2020
  • Supported SUSTOL and CINVANTI Core Project Teams in achieving cross-functional corporate objectives, including timeline, budget, and risk management.
  • Supported the SUSTOL and CINVANTI Commercial and Medical Affairs Program Leads in developing brand strategy and identifying life cycle management opportunities, including functional budget planning.
  • Led the successful delivery of the Helping Opioid Prescription Elimination (HOPE) initiative by driving strategic planning, ensuring the involvement of key internal stakeholders and the external Steering Committee, and providing project management oversight for the Investigator Meeting.
  • Responsible for the successful delivery of the Chemotherapy-Induced Nausea and Vomiting (CINV) and Pain Portfolio Publication Strategies by managing the development and submission of scientific publications, including abstracts, posters, oral presentations, and key manuscripts.
  • Partnered with Commercial and Medical Affairs to recruit key opinion leaders and healthcare professionals for a scientific council and author scientific publications.
  • Spearheaded the Publications Working Group (PWG) to maintain alignment and effective communication across Medical Affairs, Commercial, Clinical Development, Biostatistics, and Clinical Operations.
  • Supervised the publications vendor, ensuring adherence to timelines and quality standards while providing status reports to Core Project Teams and PSC.
  • Supported the SUSTOL CMC Product Team by ensuring the timely delivery of all CMC program deliverables, including timeline management, risk management, budget management, and escalation of breakdowns.
  • Supported all Clinical Development programs across the PAIN and CINV franchises.
  • Designed and implemented Risk Management training and a Risk Tool/Log to enhance risk tracking for all Program and Study Teams.

Director, Program Management

Intercept Pharmaceuticals
San Diego, CA
01.2017 - 01.2018
  • Led the Cholestasis Program Team and sub-teams, including the Lifecycle Planning Team, Fibrosis Working Group, and Global Integrated Launch Team, to maintain leadership in Primary Biliary Cholangitis (PBC).
  • Developed tools and business processes to support the active management and communication of all Cholestasis Program initiatives, activities, risks, resourcing needs, timelines, and budgeting concerns.
  • Implemented a Stage Gate process, including the use of Product Concepts/TPPs and Global Development Plans, to streamline decision-making for OCALIVA in Primary Sclerosing Cholangitis (PSC).
  • Developed an Implementation Plan in collaboration with the Vice President of Clinical Operations to streamline the shift to a fully outsourced model for clinical studies and manage the transition of clinical contracts and payments.
  • Spearheaded the creation and execution of risk management tools, processes, and training for program teams.
  • Mentored and coached colleagues on effectively incorporating continuous improvement methodologies to navigate business challenges.

Director, Project Management

Jazz Pharmaceuticals
Palo Alto, CA
10.2015 - 01.2017
  • Provided program management leadership for programs in the Sleep Franchise portfolio, establishing a strategic roadmap to support planning, decision-making, and prioritization.
  • Provided strategic project management leadership to the Commercial Brand Team, driving the development of the Brand Plan and execution of the Sleep Franchise's annual Brand Objectives.
  • Managed alliances with external business partners for the Sleep Franchise, ensuring achievement of partnership contract deliverables.
  • Created and actively managed project budgets across all functions, ensuring accurate budget variance reporting and quarterly budget projections.
  • Prepared comprehensive project updates for governance meetings, clearly communicating status through written documents and presentations.
  • Identified project risks and developed mitigation and contingency plans, ensuring proactive management of potential issues.

Global Program Manager

Amgen Inc.
Thousand Oaks, CA
04.2014 - 10.2015
  • Led the creation and implementation of comprehensive, cross-functional global strategic program plans for the early development AMG 581 Schizophrenia program.
  • Oversaw the Program Portfolio Budget process, including the development of asset-level slide decks for Early Review Board prioritization.
  • Directed program management for the AMG 581 Schizophrenia Product Strategy Team, and Global Development, Regulatory, and Product Delivery teams, driving efficient and effective development.
  • Orchestrated the deployment of a new commercialization and decision-making framework.
  • Conducted program-level scenario planning and risk analysis to identify potential challenges and develop mitigation strategies.

Senior Project Manager

Amgen Inc.
Thousand Oaks, CA
10.2008 - 10.2015
  • Led the Commercialization and R&D Compliance (Center of Excellence (CoE)) Risk Management initiative, assembling a team of Risk Experts to develop a consistent and sustainable approach to Risk Management best practices.
  • Developed and implemented a comprehensive Risk Management strategy for Amgen’s drug development programs, enhancing decision-making processes and providing essential tools, templates, and training materials.
  • Led the cross-functional Technical & Regulatory Risk Assessment work stream, a critical part of the 'portfolio decision making' initiative.
  • Delivered comprehensive Project Management Professional (PMP) certification training to internal and external audiences.
  • Served as the Therapeutic Area (TA) Lead for the cross-TA Pipeline Investment and Portfolio Planning (PIPP) work stream.
  • Provided comprehensive project management support for Global Regulatory, Development, Operations, Payer, Commercial Strategy, and Project Management teams, including sub-teams (such as CMC, Device, and Fast-To-Market), across multiple programs: AMG 334 (Migraine), AMG 747 (Schizophrenia), AMG 151 (Diabetes), AMG 876 (Diabetes), XGEVA® (Oncology), and Prolia® (Bone).
  • Led the creation and maintenance of timelines and driving the completion of the Briefing Book for the sBLA meetings, for the Bone Mets Free Survival (BMFS) Prostate Cancer (PC) and Giant Cell Tumor of the Bone (GCTB) indications for XGEVA®.
  • Led the XGEVA® BMFS PC filing team to achieve a high-quality submission in the US ahead of schedule.
  • Led the Prolia® Chemotherapy Induced Bone Loss (CTIBL) Complete Response team, facilitating a successful submission and approval of the indication in the US.
  • Led successful preparation and execution of the Oncology Drug Advisory Committee (ODAC) Meeting for BMFS PC by clear and effective planning, organizing real-life simulations with help of key opinion leaders, foreseeing operational risks, and implementing mitigation resulting in flawless execution.
  • Provided project management support for the BMFS PC ODAC Advocacy team, driving the creation of a strategic advocacy plan and timelines.
  • Led simultaneous marketing authorization filings for Denosumab Oncology and Bone in collaboration with Daiichi-Sankyo and GSK, achieving successful J-NDA and MAA submissions through effective leadership and cross-functional teamwork.
  • Led the D-CARE China CTA Core Team to advance the XGEVA® Adjuvant Breast Cancer Clinical Trial Application, ensuring timely provision of all required sections.
  • Collaborated with the Amgen-GSK China CTA Regulatory Affairs Team to align submissions, facilitating the progress of the XGEVA® Adjuvant Breast Cancer Clinical Trial Application.
  • Facilitated the kick-off and chartering of the new Insights and Brand Platform Team (IBPT) in alignment with the Amgen Commercialization Framework.
  • Directed the Value Proposition Working Group to maintain progress and alignment on the evidence package essential for achieving targeted access and pricing for AMG 334.
  • Managed the Technical and Regulatory Risk assessment and subsequent close-out processes for the terminated AMG 747 schizophrenia program, enhancing operational efficiency.

Education

Project Management Professional (PMP) -

Project Management Institute
01-2007

Bachelor of Pharmacy -

University of The Witwatersrand
Faculty Of Medicine
01-1993

Skills

  • Executive Leadership
  • Strategic Planning and Implementation
  • Strategic Communication
  • Operational Excellence and Execution
  • Project and Program Management
  • Full Lifecycle Product Development
  • Portfolio Management
  • Risk Management and Risk Mitigation
  • Governance Development & Management
  • Alliance Management
  • Budget Management and Long Range Planning
  • Resource Management
  • Vendor and Contract Management
  • Cross-functional Communication & Negotiation
  • High-Performance Team Building and Management
  • Interpersonal Skills
  • Continuous Process Improvement
  • Collaboration
  • Decision-Making
  • Creative Thinking
  • Research and Development
  • Commercialization
  • Launch Planning

Additional Career Experiences - Available Upon Request

  • Clinical Study Planning Senior Manager | Amgen Ltd. - United Kingdom | 05/2006 - 09/2008
  • Project Manager | Takeda Global R&D Centre - United Kingdom | 07/2005 - 05/2006
  • Clinical Project Scientist | Takeda Global R&D Centre - United Kingdom | 01/2004 - J07/2005
  • Lead Medical Development Planner | Pharmacia Ltd. / Pfizer Ltd. - United Kingdom | 04/2001 - 10/2003
  • International Study Team Leader – Respiratory Clinical Research | GlaxoSmithKline plc - United Kingdom | 01/1997 - 03/2001
  • Clinical Research Associate | Glaxo Wellcome South Africa (Pty) Ltd. - South Africa | 01/1995 - 12/1996
  • Pharmacist Intern | Sandown Pharmacy, South Africa | 01/1994 - 12/1994

References

References available upon request.

Timeline

Project Management Consultant

Soleno Therapeutics
12.2024 - Current

Executive Director, Medical Affairs Strategy & Ops

Axsome Therapeutics
07.2023 - 06.2024

Director, Medical Affairs Operations

Acadia Pharmaceuticals
05.2020 - 07.2023

Director, Program Management

Heron Therapeutics
02.2018 - 04.2020

Director, Program Management

Intercept Pharmaceuticals
01.2017 - 01.2018

Director, Project Management

Jazz Pharmaceuticals
10.2015 - 01.2017

Global Program Manager

Amgen Inc.
04.2014 - 10.2015

Senior Project Manager

Amgen Inc.
10.2008 - 10.2015

Project Management Professional (PMP) -

Project Management Institute

Bachelor of Pharmacy -

University of The Witwatersrand

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Michelle Frank