Summary
Overview
Work History
Education
Skills
Websites
Accomplishments
Affiliations
Certification
Timeline
Publications
Professional Profile/Key Competencies
Generic

Bernadette Oades

Jersey City,New Jersey

Summary

Strategic and results-driven biopharmaceutical program leader with managing complex cross-functional teams across key therapeutic areas - oncology, vaccines, CNS, and diagnostics. Proven track record of driving drug development programs to market, ensuring alignment with strategy, timelines, and corporate objectives. Excels in collaborative leadership, governance and key stakeholder management. Passionate about applying strategic thinking, operational excellence and innovation.

Overview

23
23
years of professional experience
1
1
Certification

Work History

PM Lead Consultant/GPAM

Merck Research Labs
02.2024 - 08.2025
  • PM Lead for high impact cross functional teams (EDTs, PDTs, DxDT, JPT, JSC) for vaccine and oncology partnership programs, developing the strategic plans, timelines, scorecards, priorities, risk mitigation strategies, aligned with corporate goals and governance endorsements. Programs include:
  • Vaccines: RotaTeq/V260, MVP+/MMRV family
  • Oncology: MK-4830, MK-0482, MK-1484, MK-7119
  • Companion diagnostics: PD-L1 22C3 IHC Assay for MK-3475 (Pembrolizumab)
  • Led teams for the development of materials for DTRC/LDRC governance, project reviews for ID/Vax strategy committee, reflecting overall program strategy, budget, and/or timeline shifts.
  • Conducted project retrospectives for continuous improvement of current processes, team dynamics, strengthen internal/external partnerships to drive successful business results.
  • Responsible for monthly program status reporting, timelines, annual priorities, risks, DQQT checks and relevant team information to ensure quality and reliable project information for stakeholder decision-making and reference.
  • Provided guidance and mentorship to PM colleagues for best practices, process improvements and knowledge sharing
  • One year contract + extension

PM Lead Consultant, Dev Program Management

Biotheryx, Inc.
04.2023 - 10.2023
  • Co-lead the cross-functional PDT (product development team) in partnership with the PTL (Project Team Lead) to develop the strategic plans for BTX-9341 (a bifunctional protein degraders of cyclin-dependent kinase 4 (CDK4) and cyclin-dependent kinase 6 (CDK6), solid tumor-breast cancer) and drive the project timeline execution for IND submission. Key activities include: development of high-quality integrated project plans aligned with corporate goals and objectives, coordinated a program risk workshop, identification of the annual team goals, management of PDT meetings, functional subteam meetings, and focused discussions, as needed. Key stakeholder tracking/management tools are Smartsheet, MS Office.
  • Collaborated in managing the activities of the CROs and medical writing agencies to deliver the data/reports from key nonclinical studies and PhI/FIH clinical study protocol to support the pre-IND meeting briefing book and the documentation required for IND submission.
  • Provided guidance for process improvements and transparent communications to establish professional, ‘ways of working’ with our partnerships to successfully execute on BTX key goals.
  • 6-mons contract

Director/Development Program Management

Genmab Inc.
08.2021 - 02.2023
  • Partnered with CDTL and Clinical Lead, for the coordination and planning of key cross-functional activities for the complex clinical program asset Epcoritamab/EPCORE program (a monoclonal antibody bispecific CD20-directed CD3 engager) for DLBCL (diffuse large B-cell lymphoma) late stage as well as FL (follicular lymphoma), early stage development. Activities include translation of strategy into operational planning, effective internal/joint strategy team meetings, timely team review of key clinical documents and other key activities- program timelines, budgets, and branding of the EPCORE clinical trials.
  • Strive for excellence, on-time delivery, and successful outcomes of EPCORE DLBCL inspection readiness at Genmab in US. Defined and refined the best practices for team effectiveness and process improvements to be carried over to the subsequent wave of inspections in EU and Japan.
  • Continually streamlined internal and joint processes (‘ways of working’) to establish efficiencies and improve partnered relationships for successful project execution and collaboration effectiveness.
  • Increased transparency of information with the establishment of one-stop program information in MS Teams to include trial and program status reporting, timelines, risks, publications, commercial landscape, and relevant team information.
  • Provided guidance to the program to increase efficiency, visibility, and strengthen relationships and trust within the Genmab.

PM Lead Consultant/ Onc Dev Program Mgmt

Bayer Pharmaceutical
01.2020 - 07.2021
  • Responsible in managing the oncology early development plans for the next generation NTRK inhibitor, Selitrectinib Phase I/II (solid tumors harboring NTRK fusion). The established plan was based on a highly complex program from development to launch. Redefined the best/base case plan aligned with the development strategy. Collaborated with the functional team for developing scenarios that are time and/or budget-optimized for the program.
  • Accountable for the quality of the forecasting and management of the external budget in order to achieve targets. Responsible for managing project LE (latest estimates), LTC (long term costs) budgets and risks and presenting during program/budget review meetings.
  • Collaborated with the team to identify, monitor and maintained annual key/governance/team goals, and communicating changes to key stakeholders.
  • Prepared the holistic program risk/opportunity profile and mitigation plans. Facilitated team preparation for periodic program reviews (e.g., for holistic portfolio review, program strategy meetings, PRM (program risk management) workshops, portfolio budget reviews or lessons learned and contributed to process improvement, identification of critical success factors, and/or facilitation of governance portfolio analysis, risk-management and decision-making.
  • Collaboration programs. Managed routine communications with (co)-development partners for licensed in-products or single study agreements, which include development of JPT and JDC agendas, meeting notes, coordination of meetings and managing partner collaborations.
  • Productively engaged program team members for results within formal GPT meetings and day to day interactions by motivating, delegating and collaborating on the programs onsite and virtual due to COVID-19.
  • One-yr contract + extension

PM Consultant/R&D Project Leadership

BMS/Celgene
07.2019 - 12.2019
  • Responsible in managing multiple early Dev oncology programs (pre-clinical to Phase I/DC nomination to POC)
  • Co-lead multifunctional translational project teams with the Preclinical Dev Project Team Lead and drive project execution and on time delivery of milestones across functional areas in accordance to the clinical development plan
  • Worked with team members (Trans Med Dev, NCD (Tox/ClinPharm), CMC, Early Commercial, RA as well as JDC/JSC members to developed the early Development Strategic Plan, timelines, risks and other key project status reporting in the PM system and other tracking tools (i.e. SharePoint.)
  • 6-mons contract

Senior Project Manager/R&D Project Management

AbbVie/Allergan
02.2016 - 07.2019
  • Responsible for the effective management (organization, planning, execution, monitoring and controlling, and evaluation) development programs, early to late-stage development (Phases II-IV) as well as post-marketing requirements/commitments for Vilazodone-HCL/Viibryd, Levomilnacipran/Fetzima (CNS), Armour Thyroid and Nebivolol/Bystolic (Internal Medicine).
  • Lead and co-lead multifunctional core teams to develop the strategy and drive project execution and on time delivery of milestones across functional areas in accordance to the product development process, Growth Product Flow.
  • Effectively managed external partners and alliances, facilitating annual joint development and steering committee meetings (JDC/JSC)
  • Effectively collaborated with Governance Board, R&D Leadership Team, communicating key project update, budget, risks and proposed resolutions to program related issues.
  • Worked with cross functional team (i.e. ClinDev, Regulatory Affairs, NTS (Tox/ClinPharm), CMC, Medical Affairs, Commercial to developed and maintained the Global Development Strategic Plan (GDS), timelines, budget, risks and other key project status reporting in the PM systems (Plansware, Enrich), and other tracking tools.
  • Routinely provided quarterly budget updates to Governance Boards, and worked with team members towards significant cost savings and more accurate forecasting, while managing forecast projections in PM systems.
  • Representative for Allergan in steering committee of a consortium of pharmaceuticals to complete an overarching PMRs (post marketing requirements) for the commercialized opioid products. Key contributions for Allegan’s Kadian/morphine ER include budget management, weekly participation in consortium meetings, company votes for updates to key deliverables, and management of vendors.

PM Consultant/Value Stream Management

Janssen Pharmaceuticals (subsidiary of Johnson & Johnson)
05.2014 - 01.2016
  • PM Lead for drug product divestiture of U.S. License Rights to NUCYNTA (tapentadol), NUCYNTA ER (tapentadol) extended-release tablets and NUCYNTA (tapentadol) Oral Solution to Depomed Inc. for 1.055 billion. Responsible for NUCYNTA and other product delistings, utilizing FPX project leadership methodologies from project scoping, planning, execution and aftercare. Strategically planning and ensuring the successful execution and closeout of the implementation plans.
  • Facilitated the development and coordination of change controls reviews/approvals required, to include both global and local sites as well external partners.
  • Project management leadership to the Issues Management Team, which includes planning (integrated timelines), coordination and execution of assigned Life Cycle Management Projects within the Value Stream Management to ensure successful delivery of the program’s key deliverables.
  • Managed global multifunctional project teams and project information, which included: project status, risk identification/management, budget, preparing meeting agendas, recording meeting minutes, tracking action items, regular updates to project tracking tool (i.e. Oracle based software, Clarity and Instants) as well as coordinating activities virtually at the global and core team levels.
  • One year+10-mons contract

PM Consultant/Global Established Products

Pfizer Pharmaceuticals
08.2013 - 03.2014
  • Managed the progress of the overall Diazepam/benzodiazepine program key deliverables in support of NDA submission strategy, which include (but not limited to) Clinical Study Reports (CSR), review/approval of key NDA clinical components.
  • Managed/facilitated a multifunctional team both at the senior leadership core and project team levels that consisted of internal/external stakeholders to ensure successful delivery of the program’s key activities.
  • Led and managed the development and team execution of integrated project timelines to ensure adherence to the NDA submission strategy.
  • Responsible for regular project status reporting highlighting KPIs and risk management/mitigation to Senior Management and project team members.
  • 8-mons contract

PM Consultant/Project Management Office

Novartis Pharmaceutical Corporation
08.2010 - 02.2014
  • PM Lead for project management strategic alliance for the global launch of Oncology drugs in partnership with Global Commercial Lead. Managed the LMT (Launch Management Team) meetings and facilitated communications amongst a multifunctional team. Notable global go-to-launch products and associated indications:
  • Signifor Acromegaly
  • Afinitor TSC AML Sep 2012
  • Afinitor Breast Cancer May 2012
  • Afinitor Neuroendocrine Tumors Mar 2011
  • Afinitor TSC SEGA Feb 2011
  • Project Management Lead for Global Commercial Excellence initiative for the rollout of the LaunchPad (iPad) across multiple global Oncology brands (Afinitor, Signifor, Sandostatin, JAKAVI, Tasigna/CML.) Responsibilities include timeline development, agency management, key stakeholder follow-ups, and communication, execution, and facilitation of LaunchPad rollout for commercial and training activities.
  • Led and managed the team execution of the integrated timelines to ensure adherence to overall global GoToLaunch activities of the drug.
  • Lead for a multifunctional team that consisted of internal stakeholders as well as external agencies for the strategic development and approved deliverables for the launch toolkit, training and development needs, and promotional campaign.
  • Responsible regular project status/metric reporting to Senior Management and project team members.
  • 3.5 years contract

PM Consultant/Global Project Management

Sunovion Pharmaceutical (formerly Dainippon Sumitomo Pharma of America)
01.2009 - 01.2010
  • PM lead for Lurasidone/Latuda (antipsychotic medicine for schizophrenia and bipolar disorder) NDA submission, which include (but not limited to) data delivery, SDTM conversion, coding, Clinical Study Reports (CSR), review/approval of key NDA summary documents i.e. ISE, ISS, CSE, CSS, Clinical Overview
  • Collaborated in the development of the plans for multiple pivotal clinical/clinpharm studies.
  • Facilitated communications and lead strategic meetings with the senior committee, multifunctional groups – Data Management/Biostats, Regulatory Affairs, QA, Clinical Dev, Clinical/Clinpharm as well as multiple external vendors (CROs) to ensure adherence to key milestones targets, identification of risks/project related issues, resource requirements, and initiation of contingency plans as appropriate
  • One year contract

Project Manager/Portfolio Resource Management/ WWPS

Pfizer Global R&D
11.2007 - 12.2008
  • PM Lead for Project/Portfolio Management for Early Development (Preclinical – Phase II) compounds across multiple TA (therapeutic areas including oncology) and facilitated communications for portfolio management governance committee and Pharm Sci Team leads
  • Managed project budgets, project summaries/dashboard reports, risks using customized database applications
  • Trained and facilitated portfolio risk analysis (identification/analysis/mitigation plans) with project teams
  • Provided PM leadership for CoDev Team to derrisk activities in support of product launch Toviaz
  • Monitored the execution of project timelines to ensure adherence to overall strategy
  • Collaborated with the team to develop continuous improvement of current processes (timelines, risks, portfolio)

Project Manager/New Product Logistics/Operations

ROCHE
09.2002 - 10.2007
  • Launched several PCR diagnostic test products on time or ahead of target for product availability in both global and US markets. Continued to participate in post launch activities and reviews.
  • Managed the delivery and manufacture of new product developments for clinical trials as well as commercialized products for launch.
  • Communicated, reviewed, approved and compiled all required deliverables and milestone documentation for projects in accordance to Design Control Commercialization (DCC) Process.
  • Utilized project timelines to manage projects and provided effective communication to the team by using various project management tools (i.e. MS Project, MS Office, SAP).
  • Lead teams in various strategic initiatives to improve Operations internal and global processes.
  • Responsible for monthly summary reports and strategic plans to Senior Area Management
  • Collaborated with RA in the preparation of PMAs, BLAs, 510(k), CE Mark for new products by providing the required the creation of labeling/documentation and manufactured lots for clinical trials and release testing.

Education

BA - Biology/Chemistry

Rutgers State University of New Jersey, College of Art & Sciences
Newark, New Jersey

MBA Dual Specialization - Marketing/Innovation Entrepreneurship

D'Amore-McKim School of Business, Northeastern University
Boston, Massachusetts
01.2016

Skills

  • Generative AI for Project Managers and Business Leaders, PMI – Nov 2023
  • PERI training: Oncology, Pathophysiology, current Therapies, Clinical Trials, Drug Development – Dec 2022
  • Effective Project Management 32nd Annual Symposium, PMINJ – May 7, 2018
  • FPX Project Leadership Workshop (Johnson & Johnson) – Jan 2015
  • Strategic Project Leadership Certification – Oct 2012
  • Development of Clinical Study Report – Oct 2009
  • AIM (Accelerating Implementation Methodology) Pfizer –Aug 2008
  • Portfolio Project Management (PPM) – Nov 2008

Websites

Accomplishments

  • Merck Project teams points nominated for ONC program management leadership/successful delivery, 2024 – 2025
  • Allergan Recognition Award for US Submission of Byvalson – June 2017
  • J&J’s Recognition Award for Prelaunch Readiness for Paliperidone ER – May 2015
  • Pfizer Recognition Award for Teamwork for Diazepam Submission Strategy 2014
  • DSPA (Sunovion) PRISM Award for Exceptional Job Performance – December 2009
  • DSPA (Sunovion) PRISM Award for Exceptional Job Performance – April 2009
  • Roche Recognition and Recognition Award for Excellence in Job Performance – December 2004
  • Roche Promotion from Associate Project Manager to Project Manager – January 2005

Affiliations

  • Member of Project Management Institute (PMI) 2005 – Present
  • Healthcare Businesswomen’s Association (HBA) 2021
  • Member of Drug Information Association (DIA) 2009

Certification

  • PMP (Project Management Professional) Certification, PMI, Jan 2010 – Present
  • Artificial Intelligence in Pharma and Biotech, Executive ED, MIT Sloan School of Mgt, Sep 2025 – in progress
  • Discipline Agile Scrum Master (DASM), PMI, coursework complete, certification in progress – 2025

Timeline

PM Lead Consultant/GPAM

Merck Research Labs
02.2024 - 08.2025

PM Lead Consultant, Dev Program Management

Biotheryx, Inc.
04.2023 - 10.2023

Director/Development Program Management

Genmab Inc.
08.2021 - 02.2023

PM Lead Consultant/ Onc Dev Program Mgmt

Bayer Pharmaceutical
01.2020 - 07.2021

PM Consultant/R&D Project Leadership

BMS/Celgene
07.2019 - 12.2019

Senior Project Manager/R&D Project Management

AbbVie/Allergan
02.2016 - 07.2019

PM Consultant/Value Stream Management

Janssen Pharmaceuticals (subsidiary of Johnson & Johnson)
05.2014 - 01.2016

PM Consultant/Global Established Products

Pfizer Pharmaceuticals
08.2013 - 03.2014

PM Consultant/Project Management Office

Novartis Pharmaceutical Corporation
08.2010 - 02.2014

PM Consultant/Global Project Management

Sunovion Pharmaceutical (formerly Dainippon Sumitomo Pharma of America)
01.2009 - 01.2010

Project Manager/Portfolio Resource Management/ WWPS

Pfizer Global R&D
11.2007 - 12.2008

Project Manager/New Product Logistics/Operations

ROCHE
09.2002 - 10.2007

BA - Biology/Chemistry

Rutgers State University of New Jersey, College of Art & Sciences

MBA Dual Specialization - Marketing/Innovation Entrepreneurship

D'Amore-McKim School of Business, Northeastern University

Publications

  • OnTrak Testcup 5: A Multi-analyte Immunoassay Device for ON-Site Drug Testing J.-C. Tsai PhD
  • J. Towt, PhD, B. Oades, BS, F. Rashid, MS, L. Talbot,BS, B. Twarowska, MS and S. J. Salamone, PhD. Roche Diagnostics Systems, 1080 US Highway 202, Somerville, NJ 08876 35th Annual Meeting of the International Association of Forensics Toxicologists, (TIAFT) Padova, Italy August 24-28, 1997

Professional Profile/Key Competencies

  • Competency Area Key Highlights
  • Leadership
  • Proven track record of leading global, cross-functional teams (R&D, Regulatory, Clinical, Commercial, Operations) across top pharma and biotech.
  • Experienced in governance interactions and steering committee leadership; strong representation in high-stakes reviews and decision forums.
  • Mentor and coach for project management colleagues; supervised and developed R&D scientists and junior project managers.
  • Strategic Thinking
  • Expert in developing integrated strategic plans aligned with corporate goals, ensuring clear translation from strategy to execution.
  • Skilled at scenario planning (time vs. budget optimization) and risk-based decision-making for complex development programs.
  • Successfully led development, US/ex-US filings, global launches, and product divestitures in alignment with corporate priorities.
  • Problem Solving
  • Adept at identifying risks and creating mitigation plans; led retrospectives and continuous improvement initiatives to enhance processes.
  • Resolved cross-functional challenges in regulatory submissions, inspections, and global collaborations.
  • Applied scientific and operational expertise to improve assay performance, efficiency, and program transparency.
  • Planning & Prioritization
  • Expert in building and maintaining integrated project plans, timelines, scorecards, budgets and prioritization frameworks across therapeutic areas.
  • Skilled at facilitating annual goal-setting and resource allocation exercises with leadership teams.
  • Led complex NDA submission planning (40+ trials coordinated), ensuring on-time and successful regulatory filings.
  • Operational Excellence & Results Orientation
  • Delivered multiple NDA/510K/BLA submissions ahead of schedule; ensured inspection readiness for late-stage programs.
  • Achieved on-time global launches and executed multimillion-dollar divestiture deals.
  • Recognized with performance awards for exceptional delivery and continuous improvement in forecasting, cost savings, and program execution.
  • Communication & Collaboration
  • Strong communicator with extensive experience presenting program updates, risks, and strategies to executive governance boards.
  • Effective partner management with CROs, vendors, and co-development partners; established transparent 'ways of working' for success.
  • Facilitated global multifunctional meetings and managed external consortium communications on post-marketing requirements.

Similar Profiles

CREATE PROFILE