Denise M. Ramsey
Oakland,CA
Summary
Well-versed portfolio and team leadership professional seeking to apply 20+ years of collective experience in the biotechnology field to an exciting new opportunity. Experience centered around cross- functional and cross- company team leadership focused on strategic development and execution. This includes, but is not limited to: in- licensing due diligence, product development, life cycle management, CMC management, commercial operations including market introductions, brand management and early discovery processes/ lead molecule identification and screening. Facets of corporate projects collectively represent an individual aptitude for understanding global drug development and project strategy.
Overview
32
32
years of professional experience
Work History
Board Member
San Francisco Vikings Soccer Club
2024.02 - Current
- Solidify strategic direction for xx years and execution plan
- Member of the operations team to implement master plan for club growth and retention
- Helped to identify strategic relationships with other soccer clubs as an expansion strategy
Executive Director, Program Management
Aditum Bio VC/ Via Nova Therapeutics
2021.01 - Current
- PTL for Anteris and Via Nova Therapeutics
- Managed due diligence teams for potential in-license opportunities by ensuring critical gaps are identified leading to a final Board recommendation (in conjunction with BD)
- Drive execution of in-licensed products to proof of concept (POC)
- Lead IND efforts
- Prepared and presented program updates to the Board
- Prepared/ managed portfolio budgets and presented quarterly updates to Board, requested capital as needed
- Manage selection of required vendor & consultants (RFP to closeout)
- Evaluate funding opportunities with leadership/BD
- Negotiated contracts with vendors, securing favorable terms while adhering to budgetary constraints.
VP, Program Management
Arch Oncology (currently Defunct)
2019.01 - 2020.12
- Lead Global PMO and Alliance Management
- Process establishment, ran governance committees, established R&R, mentoring, career paths and ensured consistency across project
- Project Team Lead/ Head PM for AO- 176
- Prepared materials for Board, sat on Board quarterly reviews
Senior Director, Head of Global Program and Alliance Management
Compugen
2017.01 - 2019.12
- Lead Global PMO and Alliance Management (US and Israel): Process establishment, ran governance committees, established roles & responsibilities, mentoring, developed career paths and ensured consistency across project teams
- Formal member and alliance manager for partner relationships (joint steering committees)
- Provided support to BD on potential collaborations (timeline, data room contents, presentations)
- Lead IND filing efforts for COM 701 and COM 902
- Collaborate/ provide PM support for potential partnering deals with BD
- Participated in IP strategy related meetings
- COM701 Program Lead
- Relationship liaison with CROs- lead efforts for clinical operations/interim Clinical Ops head
- Manage early Discovery projects and participate pipeline strategy discussions
- Manage wide array of consultants (CMC, clinical, regulatory)
- Manage key governance committees (Project Review Committee, New Target Committee)
Director, Interim Head of Clinical Operations
Compugen
2018.01 - 2018.12
- Manged CRO selection process
- Responsible for managing CRO and establishing performance metrics
- Ensured Clinical Operations readiness for Compugen’s first in human Phase 1 study (COM 701)
- Oversee selection and activation of US clinical sites
- Manage budget,negotiated costs, scope changes, forecsting
- Managed investigator safety related meetings
Associate Director, Commercial Operations Business Planning
Actelion Pharmaceutical
2015.01 - 2017.12
- Strategic management of VALCHLOR Brand and Sub- teams comprising of Commercial, Market Access and Medical
- Lead efforts in implementing innovative techniques to address complex commercial issues such as competition, patient access, disease education, pricing, sales analytics interpretation, contracting strategy etc
- Managed UPTRAVI launch team- launch resulting in $200M+ the first year
- Lead on managed markets project focusing on rebate processing, contract analytics and gross to net (GTN platform implementation with an outside vendor
- Assisted in vendor selection and implementation for contract analytics, reporting/contracting
- Co- lead teams focused on loss of exclusivity strategies for PAH franchise, including anticipated generics of competitor products and shared REMS execution
Program Director, Development Sciences Project Management
BioMarin Pharmaceutical
2013.01 - 2015.12
- Global Program Lead for BMN 673 and VOXZOGO® (vosoritide)
- Collaborated with Clinical Science, Medical Affairs and Commercial on ad board planning (co-chaired global ad boards), KOL development and Steering Committee strategy
- Commercial collaboration to determine burden of disease information (i.e., value story for payers and patient reported outcome tools
- Commercial/Medical Affairs collaboration on study designs to capture Patient Reported Outcomes (tool research and validation)
- Commercial collaboration on study branding, ad boards, patient recruiting tactics
- Involved in CRO and other vendor selection along with contract/budget negotiations (RFI/ RFP)
- Vendor Relationship Manager for two main CROs
Senior Global Business Project Manager / Project Team Leader
Hoffman La-Roche, LTD (Molecular Diagnostics)
2008.01 - 2013.12
- Draft business / project plans with consideration of market conditions and profit potential
- Market introduction of products, assess performance and make appropriate recommendations for future markets (life-cycle mgmt.)
- Manage investigator lead post-marketing studies, ad board, and publication plans
Senior Project Manager (Product Development/Development)
Genentech, Inc.
2004.01 - 2008.12
- Life Cycle Management / Collaboration Responsibilities
- Managed an array of cross-functional teams, such as the Strategic Development Team
- Developed and implemented Global Life Cycle Plans for oncology, ophthalmology and specialty therapeutics (Ph 2/3 TPP development, post marketing, including publication plans)
- In collaboration with the Executive Steering Committee, ensured alignment between managed project teams, stakeholders, and international partners
- Goals establishment, budget and risk management
Project Manager (CMC Product Operations)
Genentech, Inc.
2001.01 - 2004.12
- Product Launch and Implementation Management Responsibilities
- Managed programs focused on CMC issues including product implementation, market launch, product transfers, supply chain issues and oversee regulatory updates
- In cooperation with marketing/commercial, developed plans for effective product launches
Quality Assurance Contract Manufacturing Specialist / Project Manager
Onyx Pharmaceuticals
2001.01 - 2002.12
Project Team Leader / Manager (Pharmaceutical Manufacturing)
Oread Contract Pharmaceuticals
1998.01 - 2000.12
Research Associate (Pharmacological Sciences)
Genentech, Inc.
1992.01 - 1998.12
Education
MBA -
Golden Gate University (with Honors)
San Francisco, CABachelor's Degree - Biology
University of California, Berkeley
Skills
- Cross Functional Leadership & Alliance Management
- Drug development & diagnostics expertise
- Commercial Launches
- Early Discovery/ lead molecule selection
- In-licensing diligence and execution
- Brand & Launch Team Management
- Risk Management
Publications
2019 ASCO-SITC: A Phase 1 Study Evaluating COM 701 in Patients with Solid Tumors
Timeline
Board Member
San Francisco Vikings Soccer Club
2024.02 - Current
Executive Director, Program Management
Aditum Bio VC/ Via Nova Therapeutics
2021.01 - Current
VP, Program Management
Arch Oncology (currently Defunct)
2019.01 - 2020.12
Director, Interim Head of Clinical Operations
Compugen
2018.01 - 2018.12
Senior Director, Head of Global Program and Alliance Management
Compugen
2017.01 - 2019.12
Associate Director, Commercial Operations Business Planning
Actelion Pharmaceutical
2015.01 - 2017.12
Program Director, Development Sciences Project Management
BioMarin Pharmaceutical
2013.01 - 2015.12
Senior Global Business Project Manager / Project Team Leader
Hoffman La-Roche, LTD (Molecular Diagnostics)
2008.01 - 2013.12
Senior Project Manager (Product Development/Development)
Genentech, Inc.
2004.01 - 2008.12
Project Manager (CMC Product Operations)
Genentech, Inc.
2001.01 - 2004.12
Quality Assurance Contract Manufacturing Specialist / Project Manager
Onyx Pharmaceuticals
2001.01 - 2002.12
Project Team Leader / Manager (Pharmaceutical Manufacturing)
Oread Contract Pharmaceuticals
1998.01 - 2000.12
Research Associate (Pharmacological Sciences)
Genentech, Inc.
1992.01 - 1998.12
MBA -
Golden Gate University (with Honors)
Bachelor's Degree - Biology
University of California, Berkeley
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