Hélène H. Email & Phone Number

New York, Ny, Us

2500 Valby, Dk

As 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.

New Brunswick, Nj, Us

As 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

Basel, Ch

Rendering 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.

Lawrence Township, Nj, Us

Providing 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.

Lawrence Township, Nj, Us

During 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).

Lawrence Township, Nj, Us

While 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).

Lawrence Township, Nj, Us

During 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.

Lawrence Township, Nj, Us

Lawrence Township, Nj, Us

Boston, Ma, Us

Advancing 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.

Boston, Ma, Us

Didactic 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.

Boston, Ma, Us

Albany, Ny, Us

Paris, Fr

Pharm.D, Clinical And Industrial Drug Development

Doctorate, Pharmaceutical Sciences (Clinical Pharmacology)

M.Sc, Clinical Pharmacology

Master In Public Health, Public Health Practice And Applications To Population-Based Research