Danielle Ledoux Email & Phone Number

New York, Us

Boulder, Co, Us

● Leading program management activities for multiple program teams from developmentcandidate selection through early clinical development● Providing strategic leadership in collaboration with the Program Team Leader(s)● Leading the Program Team in defining program strategy, goals, decision points and potential areasof risk and/or risk mitigation● Tracking program progress against the plan and provides up-to-date project information anddocumentation to the team, functional area management and leadership● Building the process for and developing and maintaining program plans and tracking deliverables, andprogram milestones● Facilitating program team meetings and taking detailed meeting minutes● Establishing and managing program management resources and developing programbudget management● Supporting the Program Leader in strategic portfolio reviews and coordinate team preparation incollaboration with the Program Leader for senior leadership review meetings● Contributing to & leading diverse initiatives to improve Enveda’s portfolio-wide operations,planning and execution

Cambridge, Ma, Us

• Provide key program management support for multiple portfolio assets (antibody-drug conjugate (ADC) therapies for oncology).• Ownership of integrated program planning and timeline development, updates, and tracking.• Cross-functional matrix team management for programs from pre-clinical through POC.• Ownership of program-level Smartsheet dashboards & development of dashboarding templates across the organization.• Management of key program team meetings and communication platforms, capturing decisions, actions, risks, and issues.• Support of team in development of key program documents and presentations• Strong relationship with project leads to ensure program goals, status, and risks are updated and communicated in a timely manner to leadership and the full program team.• Budget development and management with program leads and finance team.• In-house Smartsheet SME; supporting all departments with sheet design, automations, and functionality. • Support of critical workstreams & working groups as needed across portfolio assets.

Program Management with a focus on budget and IND package development for small molecule program for treating Crohn's Disease and Ulcerative Colitis. Additionally, management of the IT systems and operations.

Global Program Management- Program Management of key programs including pre-clinical development for two novel small molecule programs and project design, scope, and planning for a novel observational study in Parkinson’s Disease patients.- Managed lead program from bench to bedside in <18 months during a global pandemic and supply chain crisis with strong negotiation skills, tight budget management, and clear communication with stakeholders. - Strong budget acumen for project planning and execution within aggressive timelines and tight budgets. - Managed timelines, budgets, risks, and cross-functional communications with a large team of employees and consultants. - Management of external strategy collaboration and vendors.- Primary communicator with stakeholders about risks, delays, assumptions, and change orders. - Development of company project management policies, plans, and methods including introduction and optimization of Global Program Team structure, education on project processes, and development of project management tools. - Internal point of contact for Quality Assurance efforts and compliance across programs and functions.Operations- Oversight and continuous improvement efforts for site operations, processes, and policies including administrative functions, EH&S compliance, IT, HR, Accounting, etc. This included an internal assessment of systems for a cost savings of 46% per month in operating costs.- Leading continuous improvement efforts around IT systems and security. - Facilities management – including relocation project leadership, lease negotiations, and build-out budget management. - Coordination and engagement of Senior Leadership Team to address strategic business and operational strategies. People Management- Development of full-time employee direct report, through goal setting, coaching, and career development advice. Supporting career growth and development through training, discussions, and planning.

Coordination of the R&D project teams including; developing project plans, timelines, goals and budgets. Management of relationships with internal and external clients, stakeholders, and CROs, development of intellectual property portfolio, and oversight of all project documentation. Accountable for all aspects of laboratory operations and management; including development of laboratory policies and procedures, overseeing successful operations of a busy lab environment, design and implementation of safety program, oversight of hazardous waste program, equipment calibration and maintenance program, etc.

South San Francisco, California, Us

• Manage day-to-day operations for Drug Substance Development, Drug Product Development, Drug Product Manufacturing, Analytical Development and Quality Control in both cGMP and R&D laboratories to the highest standards of compliance. • Manage the maintenance, calibration, and metrology program including, installation, and qualification of new equipment/instruments, on-going preventative maintenance and calibration of current equipment, review of records and management of required GMP documentation for more than 450 pieces of equipment • Manage the Environmental Health and Safety Program including acting as chair of the safety committee, chemical hygiene officer and emergency response coordinator• Developed safety program to ensure compliance with local, state, and federal regulations (RCRA, OSHA, DOT/IATA etc.) including building program documentation, managing monthly internal audits, developing hazardous waste program, shipping program, job hazard assessment program and more. • Project Management activities including meeting agendas, meeting minutes, tracking of action items, coordination between various teams, creation of timelines and Gantt charts in Microsoft Project, etc. • Manage procurement process for goods, equipment and contracts. • Developed and managed the safety training programs for team of 30 employees• Facilitate, package and schedule all out-going shipments; ensure compliance with all DOT/IATA regulations for shipment of hazardous goods; support record keeping, temperature monitoring, etc.; determination and creation of all appropriate shipping documentation such as, customs invoices, packing lists, SDS, memos, etc. • Office management and administrative functions for team of 30 employees• Exceptional skills in Microsoft Office programs such as Word, Excel, Power Point and Project; extensive experience using Oracle, SAP Concur, Veeva and Adobe PDF.

Holyoke, Ma, Us

Responsible for set up and maintenance of all laboratories in the chemistry department. Preparation of solutions, maintenance of equipment, and management of the budget as well as ordering all supplies. Assisting in scheduling labs, upkeep of written lab materials and maintaining online resources for students in organic and inorganic chemistry labs. Manage the safe handling and disposal of chemicals. Primary person to troubleshoot lab results, new lab write-ups, and equipment. Updating labs and increase technology usage in current courses. Maintain an up to date inventory of chemicals as well as work towards increasing general laboratory safety. Overhauled the MSDS/SDS records to update with all chemicals currently on site. Working to dispose of older chemicals no longer being used. Created a safety committee on campus and working to design a Chemical Hygiene Plan. Co-chair of the Safety Committee for our campus as well as on the subcommittee for safety and compliance statewide.

Performed a variety of analytical tests on products to assure quality of various chemical products before shipment. Performed daily calibrations of equipment and assisted with special projects such as designing new testing procedures or analyzing new techniques being used in other facilities. Worked with the quality engineers to troubleshoot the point-in-process issues affecting lab results. Worked with samples in lint free clean room areas when analyzing some products. Extensive use of LIMS and Excel.

North Adams, Ma, Us

I assisted the admissions staff in a variety of ways to increase enrollment. I worked as a tour guide, showing prospective students around campus and helping them to work through some of the tough choices about choosing the right school for them. I also helped out with large admissions events on campus and assisted in office work as needed including mailings and administrative tasks. I also participated in call nights to prospective students to answer questions and help them to make the right choices as the continued their education. As Senior Ambassador position I acted as the supervisor of the student ambassador (tour guide) staff of approximately 25 students. I managed the schedule for all daily tours, special tours and large group events. I was in charge of scheduling and briefing the ambassador staff for all on campus events. In addition, I planned training for new ambassadors. I also helped in the admissions office with several office projects and assisted with the processing of applications while one of the counselors was on maternity leave for 3 months during heavy reading season.

Allentown, Pa, Us

I worked on a project studying the effects of genotype by environment on photosynthesis-related traits and herbivory-related traits in Lindera benzoin. I also worked in the lab analyzing the total phenolics of the ten genotypes in both sun and shade plots.

Williamstown, Ma, Us

I perfected an assay to quantitatively measure the effects of gene knockdown on IPC synthase activity in Arabidopsis. Using this assay I was able to show a significant knockdown in mutant plants versus wild type plants.