stephanie d. -

Directeur général  de transition

Directeur de projet

Directeur Commercial / Marketing / Communication

? Global Program Manager

SANODI PASTEUR - Industrie Pharmaceutique / Santé

Context: diagnostic/global launch activities’ structuration/transformation mission « Dengue Company ».

Dengue vaccine Global launch Program & organization management. Emerging countries’ pre-launch roadmaps realigned, while ensuring people enrollment to reduce time to market by:

? Focusing on cost-quality-risk & interdependencies on RA & HEMA aspects with SP Leaders to support scenario markets definition, pricing, modeling, market access variations & submission files (ATU…),

? Working in close collaboration with R&D and IO to enhance decision-making & secure-optimize business operations strategy execution (Production problematics & activities follow-up, impact of clinical on market access, modification of a pharmaceutical plant to produce the vaccine, technologies transfer on different international plants).

o Governance adapted. Program financial committee set-up & Management (> 140 m€), Flagship, Advisory board, Steering group & CODIR Committees. WS coordination, collaborative internal Digital platform set-up to boost program efficiency

? PMO Optimization /Project Leader R&D

becton dickinson - Industrie Pharmaceutique / Santé

Context: Structuration - Support BDRx projects' profitability and sustainability.

Biotech prefilled syringes. Organization and process roadmap audit to optimize global launch projects success, and to solve R&D to industrial scale-up bottlenecks on distinct international plants & biopharmaceutical bioproduction issues. PM team mentoring (lesson-learned memo cards on regulatory guidance, Product, Labelling-Packaging, cGMP, risk analysis…). Committee set-up for product candidates; Pipeline monitoring & technology acquisition.

? Senior Global Project Manager

VOLUNTIS - Industrie Pharmaceutique / Santé

Context: Diagnostic & structuration. VP challenged by Board + lack of profitability of the business due to team discrepancies on product/program management + lack of satisfaction of clients.

Cardiology and respiratory MtM platform. Department & project practices optimized using agile practices& lessons-learned. Focus on regulatory international variations & grey zone in Germany, UK, and France.

? E-health solutions & Markets Director

c2care - Industrie Pharmaceutique / Santé

Context: Diagnostic /structuration.

Stress & phobias VR applications. Elaboration/launch project roadmap. KOLs-Stakeholders mapping. Meeting with French Authority & Potential Partners representatives to discuss business & regulatory options. Mentoring on the complex and evolving regulatory landscape.

? Global Marketing Director

COUSIN BIOTECH - Industrie Pharmaceutique / Santé

Context: Diagnostic / SME transformation issue. Direct branding + OEM; FR – International SME

OEM & direct branded implants. Project-product life cycle audit & Mentoring. Strong business & regulatory challenges (EU regulation change MDR) and gaps in products’ documentation. Sensitive organizational mission,

? Global project Expert- market Insights & BI/CI

IPSEN - Industrie Pharmaceutique / Santé

Context: Transformation / top management change with impact on each level of the organization + Business challenges

New dynamism needed. Insights process improvement support needed using new digital process & tools.

Oncology & non-oncology therapy areas. Global brand team support providing analyses on market dynamics & Stakeholders’ enrollment. Product & market screening, recommendations on options regarding product’s value-proposition extension - RWE data tools outcomes: improve market visibility & BI/CI, reinforce Products’ strategies to enhance business performance.

? Global BU Director - E-Health Program

pharmagest- groupe welcoop - Industrie Pharmaceutique / Santé

Context: Structuration of the BU and of its activities- No BU head since months; dismiss of the program leader that was supposed to take the BU lead. Facilitation of next BU Head arrival.

Interconnected Hospital Pharmacies Home HCPs Data Platform solutions (RWE, blockchain, API). Global BU & Portfolio. CODIR – COPIL coordination. Roadmaps design. RA Guidance & best-practices training. 70 FTE.

? Global Program & Business Director

TOMATIS -SOUND FOR LIFE - International

Context: Crisis management - structuration & digitalization transformation issues <=> business repositioning.

Neurosciences projects’/ products’ portfolio with Consumer & Medical claims. TPPs, manuals, Labelling, IFU & Business model adjustments for MDR & FDA compliance. RAQL (evidence, process audit/review, technical files), HEMA activities.

? COO- PRRC - Program Leader

ARSPECTRA-ARVICOM - Innovation

Context: Crisis management - business model & funding issue + activities structuration.

Platform & combination-connected AR glass solutions (emergency, Hospital & Humanitarian contexts. class 1 to 3). Organizational & product-projects portfolio process review from scratch to push 2 twin start-ups to market. Business Projects’ review (material, FTE, financial). RAQL & Risk management. SPCs synthesis. Capture of submissions’ requirements to design scenario roadmaps & evaluate deviations - business market access options. QMS set-up.