Project Manager

CELIA MILA NATIVIDAD F. BAULA, PMP

E-mail: ooa11v@r.postjobfree.com

PROFILE

• Sound scientific and medical background with 8 years project management experience

• Strong skills in drug development project management; familiar with medical device development

• Strong financial and business acumen

• Able to get things done without formal authority

• Excellent Time Management Skills - able to adjust to varying priorities as the job entails

• Confident and competent when interacting with various levels of management

• Can effectively drive discussions and decisions toward desired results within and outside of project team

• Able to raise problems or challenges in a productive manner

• Able to manage sensitive and confidential information in a professional and effective manner

• Team player with demonstrated strong interpersonal skills and ability to build effective working relationships throughout all levels of the organization.

• Able to manage multiple projects, meet deadlines, and work well in a cross-functional team environment

• Detail-oriented and strong proof-reading ability

• Advanced skills with PC-based Office Applications (MS Word, Excel, Access, Publisher, and Powerpoint) including MS Project and Visio

• Able to support and conduct web conferencing (WEBEX, GoToMeeting) and videoconferencing (LiveMeeting)

WORK EXPERIENCE

2011 – Present ProMetic BioTherapeutics, Rockville, Maryland

Associate Director, Project Management, Quality and Regulatory Affairs Department

Plasma-Derived BioTherapeutics

• Build, develop and implement required Project and Portfolio Management infrastructure

• Develop business processes to capture product development processes and activities and streamline processes as appropriate

• Manage process for developing project scope, milestones, risk assessment, project charters, and, in collaboration with the team, a detailed project plan and timeline including the budget; Develop and maintain timelines for product development activities, from CMC development to BLA approval and product launch

• Support Project Directors in all aspects of assigned projects including meeting facilitation and management, alliance/vendor management, risk management and information flow

• Manage and organize project core team meetings:

o Prepare and circulate agenda

o Participate in and drive meeting discussions and issue resolution

o Capture meeting minutes and circulate to project team for review – includes project status, decisions made, next steps, action items and action item owners, and target due dates

• Responsible for proactively identifying and documenting key project issues, concerns, or challenges

• Conduct one-on-one meetings with key cross-functional team members to ensure alignment on key project activities and upcoming deliverables and to capture key issues; Work with cross-functional team members to obtain project history and key upcoming activities

• Manage communication and decision-making process across internal and external partners involved in projects

• Communicate project and portfolio status across the organization through dashboards, product summary grid, and other tools

• Participate in business development activities by providing budget and timeline estimates for inclusion in the final business proposal and business agreements; Facilitates review and approval of Confidentiality Disclosure Agreements, Letters of Intent, and Project Charter approval.

• Document “institutional knowledge”, as appropriate, to ensure project continuity

2007 – 2011 Integrated Project Management Company, Inc., South San Francisco, CA

Project Management Consultant (past clients: Dynavax, Roche/Genentech)

• Global Project Management – life science, drug (including biologics) and medical device development

o Work with global teams to develop medical devices, including travel to Europe to conduct face to face meetings with internal key stakeholders, core team and design consulting firms

o Clinical Project Management

Work with Business and Clinical Development management team to develop and update Target Product Profile

Work with cross-functional teams and Regulatory Affairs for IND submissions, CTA approval for clinical trials in Europe, and timely submission of safety and annual reports

During the IND submission: facilitate IND concurrence meetings as each section is finalized; participate in FDA teleconference as needed; generate a process map of IND submission process and document lessons learned

Work with Regulatory Affairs and Medical Monitor in responding to FDA requests for clarifications

Review clinical protocol and other clinical documents for accuracy and consistency including synopses, Investigator’s Brochure, Informed Consent Form, as needed

Work with CRA to ensure timely distribution of clinical documents and timely shipment of test materials to site including timely batch record review

Coordinate timelines with sites and laboratories to ensure data is received in a timely manner for the clinical studies

Maintain and update project schedule in MS project

Distribute timeline to project team and external service providers to ensure alignment on due dates and deliverables

Work with cross-functional teams in estimating budget requirements for planned clinical activities, including bid review

o Monitor project budget, track actual spent, projections and variances on a monthly basis and report significant variances to management.

o Communicate project budget to project team to create and maintain awareness on budget limitations and yearly projected activities

o Conduct proactive risk management and change control of all assigned projects

• Program Management

o Present program strategy, plan, risk analysis and budget to the Board of Directors during the Board Meeting

o Organize and facilitate Joint Development Committee Meetings

o Meet periodically with CEO and CFO to review program goals, assumptions, risks, issues and concerns.

o Responsible for maintaining program budget and ensuring all projected activities are reflected in the budget

• Alliance Management

o Build trust and encourage mutual respect between venture capitalist, small biotech company and a third party research and development management group

o Encourage reasonable business strategy and plan transparency between all parties involved

o Communicate important project milestones, program updates, and FDA related issues to all parties involved

• Strategy Development and Implementation

o Assist in setting and executing the strategy of a newly formed organization

• Capital Project

o Develop business justification for acquiring additional office and laboratory space for a newly formed organization worth $29M

o Document three options for new space taking into account timeline, cost, NPV, and risks

• Integration Support

o Consolidate acquiree information to demonstrate the advantages of an integrated end-to-end organization to the buyer

o Help advocate for an end-to-end organization

o Participate in integration planning meetings

• Ensure accurate and timely distribution of project deliverables.

• Participate in knowledge sharing with colleagues

• Clinical trial experience: Oncology (Colorectal Carcinoma and Chronic Lymphocytic Leukemia), Hepatitis B and C

SRI International (formerly Stanford Research Institute) Menlo Park, CA

2004-2007: Senior Project Manager III – Biosciences Division

• Manage and monitor contracts of varying complexity, commercial and government clients

• Work with business and technical staff to prepare client development plans including studies needed for IND filing

• Implement new projects according to the agreed timelines and inform the cross-functional teams of project requirements with the use of Gantt Chart

• Ensure accurate and timely distribution of project information and deliverables

• Facilitate coordination of project activities between functional groups particularly QA and technical staff

• Identify potential and emerging problems and propose an expeditious path forward

• Organize meetings, issue agendas, write minutes, and follow up on action items

• Track project progress and costs vs plans and budget of multiple projects of varying scope and complexity

• Contribute to cost analysis for new proposals

• Communicate with clients, consultants and sub-contractors as needed

• Continuously monitor subcontractor activities to achieve project goals (compliance with contract)

• Responsible for Program Management of a new software program designed for tracking and scheduling purposes

• Participate in FDA inspection, when needed

• Supervise Associate Project Manager I

Project Coordinator Supervisor- Mammalian Toxicology

• Supervise Project Coordination Team

• Coordinate different projects including but not limited to: Mammalian Toxicology, Genetic Toxicology, Biochemistry, Pharmacokinetics and Toxicokinetics

• Maintain accurate documentation of studies performed according to protocols

• Review collected laboratory data based on GLP regulations

• Troubleshoot programs necessary for data collection

• Act as a liaison between Toxicologists, Project Managers and Biological Technicians to ensure adherence to timelines

2003- 2004 TAC Worldwide Menlo Park,CA

Project/Data Coordinator -Mammalian Toxicology

• Generate required study documents prior to study initiation

• Set-up new studies in data collection software, LABCAT (In-Life, Clinpath and Necropsy module)

• Run reports at study completion

• Review laboratory notebooks for data accuracy and inconsistencies in recording

• Participate in routine training activities to maintain/enhance skill level.

• Perform studies according to the company s SOPs (dosing, clinical observations, necropsy, blood collection/bleeding, etc)

2002-2003 Quest Diagnostics Dublin, California

Specimen Processing Technician I Frozen Specimens

• Identify and reconcile specimens received from clients

• Input pertinent patient information and laboratory test codes into computer from requisitions

• Sort, process, aliquot and store specimens

1999- 2002 Consultants in Care, Inc. Riverdale, New York

Geriatric Care Research Coordinator

• Assist with dementia research and review of chart (vital signs, intake and output, signs and symptoms of illness, glucose levels)

• Collect, organize, and interpret data using statistical analysis

• Coordinate trainings for dementia support groups and in-services

• Triage telephone calls from caregivers

• Monitor and manage client’s insurance claim data, household expenses and payroll services

• Assist Geriatric Care Manager in client advocacy with service providers

EDUCATION

UC Berkeley, CA

• Certificate in Clinical Trial Conduct and Management

o Introduction to Clinical Research

o Clinical Trial Planning and Preparation

o Clinical Trial Initiation and Implementation

o Regulatory Reports and Audits

o Principles of Regulatory Affairs

o Inspections and Audits for Quality and Compliance

o Data Management and Biostatistics

• Certificate in Project Management

o Project Management Basics

o Contract Management

o Risk Management

o Project Planning and Control

o Human Factors and Team Dynamics

o Quality Management

• Overview of the Drug Development Process

University of Santo Tomas, Manila, Philippines

• Bachelor of Science Degree in Biochemistry

Far Eastern University, Manila, Philippines

• Doctor of Medicine

ASSOCIATIONS

Project Management Institute (PMI)

Toasmaster’s International

SEMINARS (1 or 2 DAYS)

Assertive Communication Skills for Women by Skillpath

Resolving Conflict within the Team

Facilitative Leadership

Managing Multiple Projects, Objectives and Timelines by Skillpath

How to Excel as a First-Time Manager or Supervisor by Skillpath

Presentation Skills Seminar by GrahamComm

Project Management in Drug Development (Discovery to Pre-clinical) by IIR

The Karrass Negotiation 2-Day Seminar

GOOD READS (I read all these books)

Acres of Diamonds by Russell Conwell

Alchemy to IPO by Cynthia Robbins-Roth

Blink: The Power of Thinking Without Thinking by Malcolm Gladwell

Celine Dion: My Story, My Dream by Celine Dion

Crucial Conversations: Tools for Talking When Stakes Are High by Kerry Patterson

Don’t Sweat the Small Stuff by Richard Carlson

Enthusiasm Makes the Difference by Norman Vincent Peale

Execution: The Discipline of Getting Things Done by Larry Bossidy, Ram Charan and Charles Burck

Failing Forward by John Maxwell

Good to Great: Why Some Companies Make the Leap…and Others Don’t by Jim Collins

How to Develop Self-Confidence and Influence People by Public Speaking by Dale Carnegie

How to Win Friends and Influence People by Dale Carnegie

I Feel Bad About my Neck by Nora Ephron

It Takes a Village by H. Clinton

Leadership, the Eleanor Roosevelt Way by Robin Gerber

Leadership is an Art by Max DePree

Leadership Presence by Kathy Lubar and Belle Linda Halpern

Living History by H. Clinton

Managing Meetings by Robert Heller

Men are from Mars, Women are from Venus by John Gray

Never Eat Alone by Keith Ferrazzi

Nice Girls Don’t Get Rich by Lois P. Frankel

Nice Girls Don’t Get the Corner Office by Lois P. Frankel

Orbiting the Giant Hairball by MacKenzie

Principle-Centered Leadership by Stephen Covey

Please Understand Me by David Kiersey

Rich Dad, Poor Dad by Robert Kiyosaki

Rich Kid, Smart Kid by Robert Kiyosaki

Secrets of the Six-Figure Women by Barbara Stanny

Smart Women Finish Rich by David Bach

Solving People Problems

Talent is Never Enough by John Maxwell

The 7 Habits of Highly Effective People by Stephen R. Covey

The 8th Habit: From Effectiveness to Greatness by Stephen R. Covey

The 12 Secrets of Highly Creative Women by Gail McNirnee

The 21 Irrefutable Laws of Leadership by John Maxwell

The 80/20 Principle: The Secret of Achieving More With Less by Richard Koch

The 360 Degree Leader by John Maxwell

The Art of Happiness at Work by the Dalai Lama and Dr. Cutler

The Automatic Millionaire by David Bach

The Black Swan by N. Taleb

The Cashflow Quadrant by Robert Kiyosaki

The Deming Management Method by Mary Walton

The Inner Game of Tennis by W. Timothy Gallwey, Zach Kleiman, and Pete Carroll

The Little Black Book of Connections by Jeffrey Gitomer

The Millionaire Next Door by Thomas J. Stanley and William D. Danko

The Millionaire Mind by Thomas J. Stanley

The Positive Principle by Norman Vincent Peale

The Power of Positive Thinking by Norman Vincent Peale

GOOD READS – continued

The Richest Man in Babylon by George S. Clason

The Seasons of Life by Jim Rohn

The Team Handbook by Barbara Streibel

The Tipping Point by Malcolm Gladwell

The World is Flat by Thomas L. Friedman

Things I Wish I Knew Before I Went Out Into the Real World by Maria Schriver

Think and Grow Rich by Napoleon Hill

Think like a Billionaire by Donald Trump

Time Power by Brian Tracy

Trump Never Give Up by Donald Trump

Understanding Variation: The Key to Managing Chaos by Donald J. Wheeler

Voice of an Angel by Charlotte Church

Way of the Peaceful Warrior by Dan Millman

What Queen Esther Knew by Connie Glaser and Barbara Smalley

Winning by Jack Welch

Who Moved My Cheese? by Spencer Johnson

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