Vicki Kelemen

Vicki Kelemen Email and Phone Number

Biotech Executive | Strategic Drug Development | Corporate and Clinical Operations Leadership @ Cardiff Oncology
Vicki Kelemen's Location
Encinitas, California, United States, United States
Vicki Kelemen's Contact Details
About Vicki Kelemen

Results-driven Pharma/Biotech executive with 30+ years of experience in strategic drug development and operational leadership. Proven track record of delivering exceptional outcomes, demonstrated through regulatory approvals and commercial successes. Recognized for visionary leadership, meticulous attention to detail, and a relentless commitment to executional excellence.As the former Chief Operating Officer of a groundbreaking oncology-focused biotechnology company with an integrated biomarker technology platform, I excelled in managing diverse responsibilities, multitasking effectively, and driving successful drug development and operations. Adept at integrating drug development strategies and tactics, I specialize in corporate and clinical operations leadership, with a strong focus on coordinating and overseeing CMC, preclinical studies, nonclinical pharmacology and toxicology, DMPK, and clinical pharmacology.Throughout my career, I have thrived on strategizing, innovating, and executing, seamlessly collaborating with Management Teams and Board of Directors to operationalize and optimize small-to-medium-size growing organizations.Key Areas of Expertise:• Strategic Drug Development and Operations Leadership• Corporate and Clinical Operations Oversight• Cross-Functional Team Management• Clinical Trial Operations Phase 1 through 4• Partnerships and Alliance Management• Clinical Pharmacology and Preclinical Studies Coordination• Manufacturing Scaling and Optimization from Early Phase to GMP Commercial• Regulatory Submission and Approvals• Innovating and Driving GrowthSpecializing in Oncology, Diabetes, HIV/AIDS, and Infectious Diseases, I bring an in-depth understanding of these therapeutic areas to create transformative treatments and improve patient outcomes.

Vicki Kelemen's Current Company Details
Cardiff Oncology

Cardiff Oncology

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Biotech Executive | Strategic Drug Development | Corporate and Clinical Operations Leadership
Vicki Kelemen Work Experience Details
  • Davick Associates
    Managing Partner
    Davick Associates Jul 2023 - Present
    Results-driven Pharma/Biotech executive with 30+ years of experience in strategic drug development and operational leadership. Proven track record of delivering exceptional outcomes, demonstrated through regulatory approvals and commercial successes. Recognized for visionary leadership, meticulous attention to detail, and a relentless commitment to executional excellence.As the former Chief Operating Officer of a groundbreaking oncology-focused biotechnology company with an integrated biomarker technology platform, I excelled in managing diverse responsibilities, multitasking effectively, and driving successful drug development and operations. Adept at integrating drug development strategies and tactics, I specialize in corporate and clinical operations leadership, with a strong focus on coordinating and overseeing CMC, preclinical studies, nonclinical pharmacology and toxicology, DMPK, and clinical pharmacology.Throughout my career, I have thrived on strategizing, innovating, and executing, seamlessly collaborating with Management Teams and Board of Directors to operationalize and optimize small-to-medium-size growing organizations.Key Areas of Expertise:• Strategic Drug Development and Operations Leadership• Corporate and Clinical Operations Oversight• Cross-Functional Team Management• Clinical Trial Operations Phase 1 through 4• Partnerships and Alliance Management• Clinical Pharmacology and Preclinical Studies Coordination• Manufacturing Scaling and Optimization from Early Phase to GMP Commercial• Regulatory Submission and Approvals• Innovating and Driving GrowthSpecializing in Oncology, Diabetes, HIV/AIDS, and Infectious Diseases, I bring an in-depth understanding of these therapeutic areas to create transformative treatments and improve patient outcomes.
  • Cardiff Oncology
    Chief Operating Officer
    Cardiff Oncology Oct 2015 - Present
    San Diego, California, Us
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  • Carling Communications
    Senior Vice President, Client Strategy
    Carling Communications Dec 2014 - Sep 2015
    San Diego, California, Us
    Leading the peer-to-peer team at Carling Communications, Inc., a San Diego-based, full-service professional services firm that specializes in marketing, advertising, and physician communications within the pharmaceutical and specialty biotechnology industries.At Carling, we live by our company creed: 1. We believe in a purposeful existence; 2. All things being equal, the journey should be fun; 3. Continuous self-evaluation breeds brilliance
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  • Ashfiled Healthcare Communication
    Senior Vice President, Business Strategy
    Ashfiled Healthcare Communication Apr 2014 - Dec 2014
    Leading the west coast business expansion for Ashfield Healthcare Communications, a full-service communications agency, specializing in healthcare professional and patient promotion and education. We have a proven track record of success changing the conversation between healthcare professionals, patients and Brands from one of engagement to one of collaboration. Our multi-channel approach ensures delivery of the right message to the right target audience through the right channel and device at the right time to achieve the desired action - with measurable results.
  • Healthed Group
    Senior Vice President, Client Advisor
    Healthed Group Mar 2012 - Apr 2014
    Clark, Nj, Us
    Leading business engagement with Pharmaceutical, Biotech, Device and Diagnostic clients, as well as working with health plans and government organizations, to develop and execute patient/consumer strategic and multi-channel tactical communication plans. Providing educational solutions for healthcare clients that lead to better outcomes for the patients/consumers, who benefit from their products, and exceptional business results. Delivering sophisticated multi-channel patient education programs to support people living with chronic and/or life-altering conditions such as cancer, diabetes and heart disease. With a critical eye for innovation and focus on best practices for establishing collaborative and enduring relationships.Brought extensive consumer expertise in disease state and product development to establish new business with clients seeking effective strategic and tactical support for device, diagnostic, oral and injectable products, in various stages of life-cycle management, across multiple disease statesCreated comprehensive, multi-channel consumer relationship marketing programs for companies seeking to improve the patient experience, as well as expand into new consumer segmentsEvaluated patient/consumer and care partner “influencers” and interaction and developed the patient experience – clinical encounter blueprint that provided the framework for consumer strategy, messaging and initiatives across a variety of disease statesCultivated senior level relationships with clients, associations and strategic partnersContributed to planning for HealthEd financial and revenue growth
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  • Somaxon Pharmaceuticals
    Executive Director, Hcp And Consumer Marketing/Communications
    Somaxon Pharmaceuticals Nov 2010 - Nov 2011
    Developed and implemented healthcare professional and consumer/patient communications, strategic and tactical plans for first-in-class insomnia medication. Essential to the position was an ability to build and direct a high-performance and cohesive team, effectively interface with all disciplines within the organization, as well as, key external constituencies (Investors, Analysts, Advocacy Organizations). Critical to success, the experience, expertise and innovation to directly reach, expand and retain the consumer/patient target audience, build brand visibility and equity while ensuring a corporate message and position consistent with the Company’s evolving direction. Experience cultivating and effectively managing alliance partnerships, paramount in an environment in which rapid product uptake and reaching growth goals was critical. Approval to market in three months with multi-channel direct to consumer program that resulted in exceeding consumer awareness and request for product goals in the first sixty days post-launchCreated consumer advocates and launched multi-media online “Sleepless in [city] Story” to generate awareness and interest in new non-addictive insomnia medicationSuccessfully partnered with internal team members throughout the organization, external partners (agencies, advocacy groups, etc.) and alliance partner on development of communication strategies, key tactics and dissemination channels for healthcare professionals and patients/consumersRapidly penetrated managed care arena achieving favorable formulary status in top plans in a predominantly generic marketEstablished and optimized key opinion leaders and Speaker BureauDeveloped and implemented strategic and tactical business plans for marketing, managed markets and direct to consumer effortsEffectively managed multi-million dollar Advertising & Promotion budget, evaluation of marketing programs and ROI metrics to maximize resource allocation effectiveness and efficiencies
  • Amylin Pharmaceuticals
    Senior Director Market Development/Market Shaping - Diabetes-Obesity - Cv Disease
    Amylin Pharmaceuticals 2008 - 2010
    Responsible for developing strategic plan that supported diabetes franchise, with emphasis on connecting patients/consumers, HCPs and advocacy organizations. Essential to the role was successfully positioning three diabetes products, preparing the market for receptivity and rapid uptake upon launch, developing resources to facilitate patient acceptance, ease of administration, and adherence. Significant, was an ability to effectively communicate and engage the consumer audience and deliver education/information that would be understood, resonate and result in specific calls to action, empowering patients/consumers to take control of their disease and effectively manage through their disease journey. Innovation and the ability to quickly establish advocacy relations and strategic partnerships were critical to success and optimal results.Developed and implemented multi-channel consumer relationship marketing program to prepare marketplace and target audienceCreated initiatives to establish a receptive market for diabetes brands, working cross-functionally across brand teams, managed markets, medical affairs, new product planning and salesCollaborated to garner support for evolving healthcare parameters around diabetes, obesity and cardiovascular disease to help elevate the self-efficacy of consumers/patients and empower them to make decisions about their careInvolvement with ADA, Stop Obesity Alliance - represented industry on STOP Steering Committee, contributing to increasing awareness of diabetes and obesity as diseases that warranted efforts to improve care and medication optionsEstablished/optimized diabetes key opinion leader relationships and involvement in clinical trial and delivery of scientific informationPartnered with internal team members throughout the organization, external partners (agencies, patient advocacy groups, etc.) and alliance partner on development of communication strategies, key tactics and dissemination channels
  • Davick Associates
    Vice President, Strategic Marketing And Integrated Communications
    Davick Associates Oct 2004 - Mar 2008
    Consulting partnerships embedded in Pharma/Biotech companies across broad and diverse therapeutic areas, including diabetes, oncology, HIV, hepatitis and infectious diseases. Developed and implemented consumer/patient strategic and communication plans, public relations initiatives and created effective and innovative approaches to commercialization challenges and opportunities. Critical to the position was an ability to quickly assimilate knowledge in different therapeutic areas, form and help manage strategic alliances with companies and their partners, develop corporate communications, marketing, managed markets and consumer/patient education strategies, create and implement alternative selling applications, interface with regulatory and medical affairs and provide strategic insight for clinical development and product life-cycle planning. Developed and executed communication platforms to support healthcare professionals, consumers/patients and advocacy organizationsPerformed and analyzed market research to identify and validate niche market and direct to consumer/patient opportunitiesDeveloped and implemented strategic and tactical business plans for HCP, consumer marketing and managed marketsCreated unique alternative marketing and sales support initiativesDeveloped and managed key opinion leaders, clinical investigators and advocatesEvaluated and implemented unique distribution and pull-through strategiesEstablished key strategic partnerships and co-promotion initiatives
  • Maxim Pharmaceuticals
    Senior Director Global Marketing
    Maxim Pharmaceuticals Dec 2003 - Oct 2004
    Us
    Senior commercial executive responsible for leading the development of the commercial organization, including establishment of the corporate communications, marketing, sales and managed markets infrastructure, product launch strategy and execution for first-in-class oncology therapeutic, and long-range strategy and life cycle management for the oncology product portfolio. Developed oncology product launch plans to effectively reach healthcare providers, patients, caregivers and advocacy groupsEstablished key advocacy and investor relations and created unique opportunities to generate corporate and product awarenessDeveloped and implemented plan for building field organization and supporting infrastructureLed due diligence for partnering and licensing opportunities in the US and EuropeEstablished and effectively managed alliances with partners and affiliatesCreated and led cross functional commercial team
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  • Agouron Pharmaceuticals
    Director Of Marketing
    Agouron Pharmaceuticals May 1999 - Dec 2003
    Senior executive representing the Commercial Operations Organization through leadership and development of the marketing team. Established and effectively managed alliance with ex-US marketing partner.• Improved communication and coordination through effective leadership and management of Roche/Agouron and Pfizer/Agouron alliance partnerships, resulting in alignment of global positioning and strategies for Viracept worldwide, and year-over-year revenue growth • Established and implemented Pfizer/Agouron Geodon co-promotion, resulting in 60% sales growth in the corrections segment and Zoloft co-promotion• Led product life-cycle strategic planning and development• Leveraged resources to optimize co-promotions and develop new strategic business initiatives with alliance partners• Directed sales and marketing team in-licensing and re-launch activities, which led to a 25% increase in product sales in the first 12 months• Implemented direct-to-patient HIV Dialogues education initiative, resulting in 4,000 newly diagnosed HIV patients nationwide, and 400 new prescriptions for Viracept ($2.4MM incremental revenue)• Directed the Viracept 625 mg NDA cross-functional team resulting in on-time submission, FDA approval, and launch execution with alliance partner• Created and implemented Brand Summit resulting in improved coordination among strategic partners, sales and marketing management, synergistic approach to professional and consumer marketing initiatives, and savings of over $3MM in promotional budget• Managed integration and collaboration strategies and initiatives between Agouron and Pfizer marketing, managed markets and field sales organizations • Developed clinical platform for Phase IV studies and publications and created educational support initiatives for clinicians and patients• Established a network of national opinion leaders to consult on strategic and clinical initiatives
  • Dura Pharmaceuticals
    Director Of Marketing, Acute Care Division
    Dura Pharmaceuticals Apr 1997 - Apr 1999
    Created institutional division to launch newly acquired injectable antibiotics (cefepime and aztreonam). Effectively managed alliance partnership between Dura and BMS pharmaceutical organizations.• Developed marketing strategy and positioning for re-launch of acquired anti-infective, resulting in 50% increase in first year sales• Created and implemented specialty market initiatives specific to the institutional environment, resulting in successful product differentiation and growth in a highly competitive market• Re-positioned and developed new strategic orientation of products to create market opportunities conducive to significant growth of both brands• Managed team of product managers, advertising agency creative and strategic group, public relations, and marketing research analysts to develop and implement corporate marketing and sales strategies for all promoted products• Responsible for overall P&L to meet quarterly and annual objectives• Developed marketing plans and advertising/promotion budgets, sales and production forecasts
  • Dura Pharmaceuticals
    Director Of Marketing
    Dura Pharmaceuticals 1997 - 1999
    Marketing communications and public relations; key opinion leader interface.
  • Bayer
    Director Of Marketing
    Bayer 1986 - 1997
    Leverkusen, North Rhine-Westphalia, De
    Managed the launch of a global anti-infective (ciprofloxacin) with responsibility for a $64 MM advertising and promotion budget; directed all national and business area strategic marketing development and implementation plans, and life-cycle management of ciprofloxacin through patent expiration.• Launch Team marketing lead for the successful introduction of ciprofloxacin, resulting in exceeding first year sales forecast by 40%• Established and successfully implemented urology and surgery specialty markets, increasing antibiotic product sales by 35% and 15%, respectively• Established relationships with key constituency groups and directed product and market related public relations activities• Developed and executed market-specific managed care strategic plans focused on disease state management and critical pathways• Implemented product line extension and formulation launches to extend product life cycle and patent protection• Led cross-functional project team, resulting in the submission and FDA approval of two new formulations and product line extensions
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Vicki Kelemen Skills

Product Launch Pharmaceutical Industry Strategy Trade Shows Integrated Marketing Strategic Partnerships Cross Functional Team Leadership Marketing Strategy Market Research Marketing Leadership Strategic Planning Business Development Management Biotechnology Product Development Oncology Managed Care Advertising Corporate Communications New Business Development Sales Commercialization Diabetes Market Planning Urology Marketing Communications Customer Insight Business Planning Account Management Global Marketing Healthcare

Vicki Kelemen Education Details

  • University Of California, Davis
    University Of California, Davis
    Pre-Medicine/Pre-Medical Studies

Frequently Asked Questions about Vicki Kelemen

What company does Vicki Kelemen work for?

Vicki Kelemen works for Cardiff Oncology

What is Vicki Kelemen's role at the current company?

Vicki Kelemen's current role is Biotech Executive | Strategic Drug Development | Corporate and Clinical Operations Leadership.

What is Vicki Kelemen's email address?

Vicki Kelemen's email address is vi****@****cox.net

What is Vicki Kelemen's direct phone number?

Vicki Kelemen's direct phone number is +185895*****

What schools did Vicki Kelemen attend?

Vicki Kelemen attended University Of California, Davis.

What are some of Vicki Kelemen's interests?

Vicki Kelemen has interest in Science And Technology, Children.

What skills is Vicki Kelemen known for?

Vicki Kelemen has skills like Product Launch, Pharmaceutical Industry, Strategy, Trade Shows, Integrated Marketing, Strategic Partnerships, Cross Functional Team Leadership, Marketing Strategy, Market Research, Marketing, Leadership, Strategic Planning.

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