Anila Dede

• Lead delivery strategy for different Medical Affairs programs of Pharma/ Biotech clients
• Consult/Advise efficient and meaningful design with alternative, innovative, DCT approaches.
• Lead stakeholders’ strategy to deliver compound related Scientific Engagement activities.
• Identify strategic alternative data sources, suitable Decentralized Trial Strategies, and data to enable recruitment innovations that led to two new successful bid pursuits.
• Align across functions, regional teams, and Sponsor´s Medical Affairs local affiliates strategy.
• Align department vision, goals, and objectives with company strategy to achieve consistently high results.

• Demonstrated a high level of initiative and creativity while tackling complex deliverables .

· Strategic advisement & planning with new venture, biotech, and Pharma in conduct of drug/device trials as part of registration & post-registration requirements

· Strategic implementation of multiple Biomarker solutions to address sponsor needs, accelerate trail timeliens and outcomes for multiple oncology.

· Accountable for strategic global planning of Oncology Studies including operational aspects of design, forecasting, global trial placement, feasibility, cost efficiencies & pricing (doubling 2021-win rate)

· Resource allocation, forecasting, planning & management of performance metrics KPIs

· Several won proposals with more than 40M brought home business through optimizing new Oncology Franchise proposals, developing compelling operational technical strategies & business solutions supporting current & future client needs.

· Led bid pursuit process preparation providing leadership & strategic direction to the bid defense team creating the strategy value proposition & solution architecture.

· Post-award Oncology portfolio support providing mitigation strategies, attending, and leading when requiring client discussions including potential rescue studies.

• Identified issues, analyzed information and provided solutions to problems.

• Led recruitment and development of strategic alliances to maximize utilization of existing talent and capabilities.
• Managed financial, operational and human resources to optimize business performance.
• Represented organization at industry conferences and events.
• Devised and presented business plans and forecasts to board of directors.

· Led medical affairs development strategies and activities associated with multiple indications assets for commercialization needs of Pharma and Biotech Clients

· Established successful bid pursuit process mapping out customer´s needs with company´s competitive offerings that generated unique value proposition and solutions architecture leading to 60 % increase on annual win rate.

· Consulted Clients on optimal study design, country/site allocation and strategic compound development & supported post approval market access needs.

· Saved 1.2M by implementing cost-saving initiatives addressing long-standing discrepancies through operational improvements that led in improved profit margins.

· Work across BUs to provide guidance for major accounts, help identify/qualify new business opportunities & assist Business Development in early engagement with prospective clients.

• Analyzed industry trends and tracked competitor activities to inform decision making.
• Shaped solutions and approaches by leveraging trends in customer marketplaces and industries.
• Formulated and executed strategic initiatives to improve product offerings.

• Developed systems and procedures for effective project management and clinical operations.
• Facilitate hiring of qualified [Department Name] personnel by interview applicants and making recommendations for employment.
• Participated in nursing research and evidence-based clinical audits and leveraged data to improve research-based methodologies within clinical areas.
• Represented organization at all community events, answering questions, providing details and giving informative presentations.

· Project oversight at client's portfolio level program to ensure execution within budget and timeline as well as client satisfaction by also Supporting development of Study Protocols aligning to program's strategy, timing, supporting funding rising efforts when needed

· Secured a successful strategic alliance with Biotech & a Start Up through a fit for purpose strategy, scope, costing negotiations & design of 3 Studies/$20M brought home business

· Oversaw hiring, training, and professional development of 2 PMs & 4 CTLs, managing training & development plan, team & individual KPIs, provided regular, actionable feedback

· Analyzed technology, resources, demand to assess feasibility & plan company projects

· Worked with functional leaders to implement new CAPA procedures to improve quality.

• Developed and maintained courteous and effective working relationships.
• Proven ability to learn quickly and adapt to new situations.
• Completed paperwork, recognizing discrepancies and promptly addressing for resolution.
• Applied effective time management techniques to meet tight deadlines.

· Led development & implementation of a program (50M) capturing data in & 17000 pts Ophthalmology-LUMINOUS developing defense strategy against competitor in preparation for data from government sponsored trials

· Set up of steering committee-15 international KOLs to generate real involvement & advocacy

· Planned & implemented R&D platform, provided strategic guidance, oversaw budgeting, and monitored KPIs through protocol development to differentiate compound medically from off-label competitors & demonstrated wider value

· Led outsourcing including bidding meetings & presentations, RFPs, contract & budget

· Maximized local registries via strategic analysis & publication planning supporting country-level implementation

· Support launch of new indications, coordinate presentations for symposia & publications,

• Gained extensive knowledge in data entry, analysis and reporting.
• Worked well in a team setting, providing support and guidance.
• Worked flexible hours across night, weekend and holiday shifts.
• Applied effective time management techniques to meet tight deadlines.

· Input for study design effectively combines marketing needs & clinical regulatory requirements for CVM-EDGE 30.000 patients and 2 Somatostatin trials at Novartis Oncology, meeting submission deadlines and FPI and Study Report

· Successfully Led CTT in cross-functional setting through protocol development, strategic planning, and budgeting and managed CROs that were conducting these studies

· Led development of Clinical Study Report and updates of Investigator brochure

• Exercised leadership capabilities by successfully motivating and inspiring others.
• Demonstrated respect, friendliness and willingness to help wherever needed.
• Proved successful working within tight deadlines and a fast-paced environment.
• Demonstrated a high level of initiative and creativity while tackling difficult tasks.

Successfully directed medical affairs operations and strategy for CNS and Ophthalmology studies, provided training for CROs, oversaw on the ground sites in multiple EU countries, Middle East. Repositioned outsourced clinical projects back to in-house optimizing internal resource availability.

• Completed paperwork, recognizing discrepancies and promptly addressing for resolution.
• Used strong analytical and problem-solving skills to develop effective solutions for challenging situations.
• Developed strong organizational and communication skills through coursework and volunteer activities.
• Delivered services to customer locations within specific timeframes.

Drove product endorsement & manage post-marketing plans. Analyzed key competitors to respond to competitive threats, secured high-value accounts through consultative selling, KOL network expansion that led to 35% sales increase. Managed CROs, deliverables of a Phase IV local study.

• Generated advertising brochure for vendor use.
• Contributed to event marketing, sales and brand promotion.
• Kept detailed records of daily activities through online customer database.
• Built diverse and consistent sales portfolio.

Built & maintained powerful base of key client accounts delivering outstanding sales record 18% increase through: market & competitor analysis, forecasting & planning for market share development and network expansion