Hélène H. Email and Phone Number
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I have experience working in the private & public sectors in both the US and the EU. My career is a testament to my dedication to enhancing healthcare outcomes through strategic leadership and innovative research. I am a well rounded clinical researcher and regulator with > 15 years experience in the pharmaceutical industry (Clinical Development,Regulatory Affairs, Medical Affairs & Strategy, Pharmacovigilance), added of 10 years experience in clinical research & academia/Teaching. Fluent in English and French, I bring a valuable perspective to diverse team settings and hold dual citizenship in France and the US. Please note the following highlights from my career...☛ Seasoned and accomplished director with over 20 years’ experience directing all aspects of clinical and medical research projects from concept to successful conclusion for the attainment of business objectives. ☛ Demonstrated expertise in infectious/rare diseases, immuno-oncology, and Matrix leader. ☛ Possess ability to build and mentor top performing teams through development and execution of clinical & research programmes, policies, and best practices. ☛ Adept at governing cross-functional meetings shaping successful strategies to support research and business needs and contribute to assessment of safety related issues and regulatory dossiers. ☛ Expert at overseeing full clinical development lifecycle from discovery to phase-IV trial. ☛ Elite communicator building robust relationships with all levels of management and stakeholders. ☛ Ready to launch programmes in high-profile organisation that appreciate professionalism and commitment.☛ English/French. Dual Citizenship (US/France)Please feel free to contact me at hhardy34@gmail.com with any thoughts, comments, or questions about my work—I’m always interested in making new professional acquaintances.
Genmab
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Vice President, Global Development Team LeaderGenmabNew York, Ny, Us
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Vice President, Global Program LeaderGenmab Nov 2024 - Present2500 Valby, Dk
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Senior Director, Compound Development Team LeaderJohnson & Johnson Innovative Medicine Nov 2019 - Nov 2024As a compound development Team leader I have worked in Therapeutic areas (Immunology [Rheumatology/Dermatology], Global Public Health [ Neglected tropical and Rare Diseases], Infectious Diseases). I have led the development of multiple assets in various stages of development (Pre-NME, Phase 1, Phase 2a/Phase 2b, Phase 3 and Post-marketing commitments/Peds programs). I championed projects at all organizational levels and provide strategic direction to guide teams through the early phase of asset development (e.g. Phase 1) to the submission of a BLA/NDA/sBLA or PMC to global regulatory agencies. Managing project progression, identifying risks and mitigating them, managing budget and engaging with internal/external stockholders are a few of the critical skills I refined over time. -
Senior Medical Director Medical AffairsJohnson & Johnson Nov 2018 - Jan 2020New Brunswick, Nj, UsAs a senior Medical Affairs Lead, I contributed to assist the medical affairs team to shaping the data generation and medical plan strategy, as well as contributed directly to shaping the publication plan. Mitigating hazards in timely manner and interacting with experts, whilst ensuring the delivery of project within agreed timescale I identified project core risks to take strategic actions. Additionally, I spearheaded multi-disciplinary and cross-functional team, which comprehend the US healthcare environment and stakeholders needs in infectious disease. I devised and applied medical development plans for disease areas. Heading advancement of study design through interaction with outcome research colleagues I planned and developed core research questions, value proposition statements, and business planning process.Some of my key accomplishments are following☛ Restructured MA team to enable integration of real-world research by conducting innovative research programs and optimize collaboration across teams.☛ Implemented series of new processes that efficiently communicate research internally/externally -
Us Head Of Regulatory Affairs - Rare DiseasesActelion Nov 2017 - Nov 2018Basel, ChRendering required documentation on-time, I drove roadmap for US registration of new drugs and indications in rare diseases. Representing regulatory affairs, I actively partook in US health authority meetings. Moreover, I supported global and regional leaders in the formulation of documents for scientific advice/ world-wide submissions of PPSR, NDA, and sNDA in-line with industrial best practices and standards.Some of my key accomplishments are following☛ Led 15 international and US operational managers/leads through several submissions to FDA for rare diseases.☛ Built a team of regulator in US, which aided global submissions of new indications of rare diseases.☛ Allocated available resources and knowledge sharing processes in-line company’s policies and procedures. -
Director, Global Regulatory Strategy Lead - Immuno-OncologyBristol-Myers Squibb Jan 2016 - Oct 2017Lawrence Township, Nj, UsProviding comprehensive guidance to teams, containing regional, CMC, operations, and labelling I executed effective strategies by rendering leadership to fulfil health agencies requirements internationally. Collaborating with FDA/EMA authorities, I addressed all concerns related to regulatory affairs.Some of my key accomplishments are following☛ Boosted team size and diversity with primary focus on building programs, teams, and research to address highest unmet medical needs and meet the business needs.☛ Created the regulatory strategy for the filing of two immune-oncology agents in Hodgkin Lymphoma Multiple Myeloma and Ph+ Acute Lymphoblastic.☛ Gained complete knowledge in medical strategy/business management, drug Safety, registration affairs, and people leadership.☛ Operated team of four, which contained RA manager, US regulatory, international leaders, and administrative assistant as per company requirement. -
Director, Clinical Development - Immuno-OncologyBristol-Myers Squibb 2013 - 2017Lawrence Township, Nj, UsDuring this role I orchestrated planning, implementation, and monitoring of research studies from phase II to IV in immuno-oncology space as medical monitor. Interpreting results for efficiency and safety clinical research, I prepared clinical and summary reports that aided global filing and different indications in IO space, such as renal, melanoma, and lung. Employing world-wide regulatory submissions, I communicated with authorities.Some of my key accomplishments are following☛ Administered entire budget and timeline for R&D activities by setting key milestones.☛ Completed all assigned projects within timely and budgetary constraints by heading project from inception to successful execution.☛ Led the design and implementation of phase-II and III trials and played a key role as clinical lead for enhancement of the regulatory packets, which were submitted to US/EU health authorities to request new indications (sNDA, NDA).
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Tour Of Duty - Global Regulatory Strategy - Immuno-OncologyBristol-Myers Squibb May 2016 - Dec 2016Lawrence Township, Nj, UsWhile maintaining full responsibilities for my clinical development activities, I conducted a Tour of Duty within the IO Global Regulatory Department at BMS, to develop and refine a regulator strategic mindset complementary and critical to successful clinical development activities (Focus: IO agents in solid tumors).
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Director Medical Affairs - VirologyBristol-Myers Squibb 2011 - 2013Lawrence Township, Nj, UsDuring this role I served as medical matrix lead and oversaw plans, which connected with communication strategy regarding two HIV products. Moreover, I coordinated two direct reports for information and advisor teams. Rendering coaching to staff with primary focus on optimizing teams’ performance, I delivered appropriate training material for MSL. Additionally, I partook in major scientific congresses, developed relationship with trial investigators, academic centres, and cooperative groups.Some of my key accomplishments are following☛ Mentored a team of four global medical affairs staff and 20 US MSLs.☛ Served as a study director on non-registration studies and outcome research studies that supported business strategy.☛ Refreshed Medical & communication strategies for atazanavir and HIV protease inhibitor by exploring scientific opportunities for business growth.
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Associate Director Medical Affairs - VirologyBristol-Myers Squibb 2010 - 2011Lawrence Township, Nj, Us
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Senior Drug Safety Scientist - OncologyBristol-Myers Squibb 2008 - 2010Lawrence Township, Nj, Us
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Director, Clinical Research - VirologyBoston Medical Center (Bmc) Sep 2001 - 2010Boston, Ma, UsAdvancing Public Health programs and research activities in behavioral sciences and adherence to HIV and HCV therapies I served as clinical researcher and professor. Working as director of adherence clinic program funded by the MA department of public health, I operated as a principal- and co-investigator for numerous research projects, funded on Industry-sponsored. I modernized and retained pharmacist record for all ACTG trials that conducted on site. I appointed for drafting and applying research protocols and oversaw publication process in compliance with research findings. Some of my key accomplishments are following:☛ Served as director of Public Health Adherence Clinic, and a few additional Public Health programs (e.g. Smoking cessation), and mentored staff on compliance and data analysis of information collected for the State.☛ Drove Clinical Research Activities focused on designing adherence tools used in various studies and oversaw entire research budget and timeline.☛ Mentored pharmacy nurses and medical students through their specialized trained in Infectious Diseases ☛ Controlled and aligned all aspects of HIV investigational drug service, such as medication dispensing, labelling, return, and policy development pertaining to HIV therapy. -
Assistant Research ProfessorMassachusetts College Of Pharmacy And Health Sciences Sep 2001 - 2010Boston, Ma, UsDidactic teaching in the area of Clinical Pharmacy, Clinical Research and Virology; Director of an ASHP accredited Residency Program for Pharm.D specializing in the area of Virology/Infectious Diseases; Clinical Practicum Head of a training program for Pharm.D students rotating at Boston Medical Center in the Center of Infectious Diseases. -
Clinical PreceptorTufts-New England Medical Center Aug 2000 - Aug 2001Boston, Ma, Us -
Clinical PreceptorThe State University Of New York Jul 1999 - Jun 2000Albany, Ny, Us -
Research ScientistInstitut Pasteur 1996 - 1997Paris, Fr
Hélène H. Skills
Hélène H. Education Details
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University Of Buffalo, School Of Pharmacy/Erie County Medical CenterClinical And Industrial Drug Development -
University Of Lille Ii, Faculty Of PharmacyPharmaceutical Sciences (Clinical Pharmacology)
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University Louis Pasteur, College Of PharmacyClinical Pharmacology
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University Of Massachusetts, AmherstPublic Health Practice And Applications To Population-Based Research
Frequently Asked Questions about Hélène H.
What company does Hélène H. work for?
Hélène H. works for Genmab
What is Hélène H.'s role at the current company?
Hélène H.'s current role is Vice President, Global Development Team Leader.
What is Hélène H.'s email address?
Hélène H.'s email address is hh****@****sen.com
What is Hélène H.'s direct phone number?
Hélène H.'s direct phone number is +161741*****
What schools did Hélène H. attend?
Hélène H. attended University Of Buffalo, School Of Pharmacy/erie County Medical Center, University Of Lille Ii, Faculty Of Pharmacy, University Louis Pasteur, College Of Pharmacy, University Of Massachusetts, Amherst.
What skills is Hélène H. known for?
Hélène H. has skills like Clinical Trials, Infectious Diseases, Pharmaceutical Industry, Clinical Development, Clinical Research, Medical Affairs, Oncology, Pharmacovigilance, Virology, Drug Development, Outcomes Research, Research.
Who are Hélène H.'s colleagues?
Hélène H.'s colleagues are Juliëtte Wezenbeek, Hadia Hamdaoui, Louise Sejer Meisner, Anja Kirkeby Goldenbæk (Ert), Anna Van Zomeren, Ryan Behrend, Larisa Hubbs, Ccep.
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