Experience

Alto Neuroscience

• United States
• Biotechnology
• 1 - 100 Employee

• Senior Vice President, Clinical Innovation

  • Sep 2023 - Present

  United States Manages a portfolio of clinical trials and technical solution informatics focused on decentralization, usability, variation, analytics and modeling works to deploy a formalized innovation infrastructure across the Alto Neuroscience R&D portfolio.

• Vice President, Clinical Innovation

  • Oct 2021 - Sep 2023

  Las Vegas, Nevada, United States Focus on decentralized clinical trials within psychiatry and focus on expanding clinical trial access to patients, by allowing them to participate in studies at-home, in their community, and with their own doctors using Alto's data driven, AI-biomarker focused platform that will ultimately change the trajectory of psychiatric medicine with its unique focus on engaging research naive providers, and points of care, in places traditional studies do not reach. Evolve the clinical research… Show more Focus on decentralized clinical trials within psychiatry and focus on expanding clinical trial access to patients, by allowing them to participate in studies at-home, in their community, and with their own doctors using Alto's data driven, AI-biomarker focused platform that will ultimately change the trajectory of psychiatric medicine with its unique focus on engaging research naive providers, and points of care, in places traditional studies do not reach. Evolve the clinical research process at a variety of levels while striving to make a more patient-centric approach. Responsible for developing, maintaining and promoting the company's decentralized clinical trial (DCT) framework, assembling patient and physician advisory boards, establishing academic and key opinion leader partnerships, driving clinical trial design innovation, ensuring other institutions and partners deploy the DCT framework, and advocating for better patient-centricity, diversity & inclusion. Expand the innovation and virtual knowledge of clinical operations and investigator/patient experience by helping design and execute global virtual or decentralized trials and lead global teams to solve trial recruitment and retention challenges by promoting and delivering precision-like psychiatric medicine.



The Janssen Pharmaceutical Companies of Johnson & Johnson

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Director, Global Development - Business Support Lead

  • Jan 2021 - Oct 2021

  Las Vegas, Nevada, United States - Acts as the single point of accountability within Global Development at the global program level and has a strong leadership accountability to lead high performing teams. - The position serves as the key contact for the Janssen Therapeutic Area Clinical Leaders/ Operational Heads / Global leaders & other Janssen Companies or external development partner companies and will represent GD in (senior) leadership/project teams as appropriate. - Lead the Trials2You Global Development… Show more - Acts as the single point of accountability within Global Development at the global program level and has a strong leadership accountability to lead high performing teams. - The position serves as the key contact for the Janssen Therapeutic Area Clinical Leaders/ Operational Heads / Global leaders & other Janssen Companies or external development partner companies and will represent GD in (senior) leadership/project teams as appropriate. - Lead the Trials2You Global Development Initiative that aims in making clinical trials more accessible and convenient through capabilities and technology that integrate the clinical trial into the participant's everyday life.

• Director, Global Development & Operations - Neuroscience

  • May 2017 - Jan 2021

  Titusville, New Jersey Portfolio Management



I AM PRODUCTS

• United Kingdom

• Co-Owner

  • Mar 2002 - Jan 2021

  Princeton, NJ At I AM Products, we believe that everyone, no matter who they are, should be able to express themselves in a manner that reflects who they are. The right fashions allow you to express yourself. . .to stand out from the crowd. . .and to tell the world, “I am not afraid of who I AM!” I AM Products is an online fashion brand that stands for human rights, diversity, inclusion and takes a stance against bullying. Our mission is to make a powerful ''I AM" global statement to help… Show more At I AM Products, we believe that everyone, no matter who they are, should be able to express themselves in a manner that reflects who they are. The right fashions allow you to express yourself. . .to stand out from the crowd. . .and to tell the world, “I am not afraid of who I AM!” I AM Products is an online fashion brand that stands for human rights, diversity, inclusion and takes a stance against bullying. Our mission is to make a powerful ''I AM" global statement to help revolutionize identity, promote transparency, advocate for human right, voice the rights for equality, and encourage freedom of expression. I AM Products help raise funds for organizations that help human rights and anti-bullying. Show less



Novartis

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Director: Clinical Trial Management (Cardiovascular & Respiratory business franchise)

  • Mar 2016 - May 2017

  Princeton, New Jersey Independently work in a cross functional environment to manage global mega trials (outcome) within the Cardiovascular and Respiratory business franchise. Lead and contribute to and support Department/Clinical initiatives to improve the quality and content of BCD and other clinical programs as well as the cross functional/organization processes designed to effectively deliver the Novartis R&D portfolio. Manage departmental and project productivity and quality metrics and provide… Show more Independently work in a cross functional environment to manage global mega trials (outcome) within the Cardiovascular and Respiratory business franchise. Lead and contribute to and support Department/Clinical initiatives to improve the quality and content of BCD and other clinical programs as well as the cross functional/organization processes designed to effectively deliver the Novartis R&D portfolio. Manage departmental and project productivity and quality metrics and provide financial and management accountability to upper management. Partner and contribute in Protocol, IB, ICF, Regulatory submission documents, CRF, CSR development and review and provide direction to junior staff to manage the process, as necessary. Effectively discuss and represent study data across the business franchise; collaborate with medical writers and investigators to write, publish and present data Develop tracking tools and oversee project metrics, budgets, study timelines, and deliverables. Show less



Sandoz

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Associate Director, Global Clinical Trials Medical Affairs

  • Dec 2014 - Mar 2016

  Princeton, New Jersey . Operationalize protocol . Manage trial allocation and coordination/management of activities leading to initiation of sites in different countries . Prepare, Implement and Manage Vendors in U.S. and other Countries . Manage overall trial conduct to trial close out in coordination with line functions and CRO . Facilitate trial close out activities

• Senior Clinical Scientific Manager

  • Nov 2002 - Dec 2014

  Las Vegas, Nevada Area • Lead, manage and oversee large & complex clinical programs (domestic & International). • Develop innovative plans, accumulate competitive intelligence trends and program architecture within the Medical Affairs division. • Function in clinical operational leadership role at R&D/PV/marketing/global meetings representing a detail in: 1) medical writing (developing study concept sheets, protocol, IB, ICF/assent, CRF design/guidelines, source documents and other study related… Show more • Lead, manage and oversee large & complex clinical programs (domestic & International). • Develop innovative plans, accumulate competitive intelligence trends and program architecture within the Medical Affairs division. • Function in clinical operational leadership role at R&D/PV/marketing/global meetings representing a detail in: 1) medical writing (developing study concept sheets, protocol, IB, ICF/assent, CRF design/guidelines, source documents and other study related documents) 2) site management (identify/select investigators, liaison with sites, CRA/staff training and host meeting (i.e. CTT/CPO/IM) 3) vendor management (select and manage CRO, laboratories, clinical distributor/depot) 4) project management (resource procurement and planning, feasibility & program implementation, master contract and master service agreement(s) initiation & maintenance, milestone planning and tracking, financial planning & maintenance, production of key project progress reports and grant plan specifications) 5) QA/monitoring (site qualifications, initiation, close out, interim co-monitoring and periodic quality assurance audits with field CRAs). Show less



PRA International

• Netherlands
• Financial Services
• 1 - 100 Employee

• Regional Expert CRA

  • Jun 2000 - Nov 2002

  Las Vegas, Nevada Area • Responsible for the establishment, monitoring and close-out of assigned clinical trials while assuring adherence to Good Clinical Practices and compliance with all study procedures. Responsible for site selection, identifying and contacting potential investigators; ensuring adequacy of clinical research. • Ensured evaluation and monitoring of regional sites for their capacity to conduct clinical trials involved with nutritional health & obesity studies. • Conducted study initiation… Show more • Responsible for the establishment, monitoring and close-out of assigned clinical trials while assuring adherence to Good Clinical Practices and compliance with all study procedures. Responsible for site selection, identifying and contacting potential investigators; ensuring adequacy of clinical research. • Ensured evaluation and monitoring of regional sites for their capacity to conduct clinical trials involved with nutritional health & obesity studies. • Conducted study initiation visits: Ensuring completion of regulatory documents, reviewing Investigator responsibilities, coordinating shipment of study-related material, and reviewing protocol and all study related procedures. • Conducted interim monitoring visits: Review CRFs for completeness and accuracy and ensure that corrections are made appropriately, perform source document verification, review Adverse Event incidence and ensure proper reporting procedures to Sponsor were conducted, and assure adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures. • Completed study termination visits/close-out visits: Resolved all outstanding DCFs, retrieve CRFs, ensure regulatory documents are available and current, ensure IND accountability and IND return and disposal, review record retention duties including attendance at clinical monitoring staff meetings, project team meetings, clinical committees, clinical training sessions, etc. Show less



Dialysis Clinic, Inc.

• United States
• Hospitals and Health Care
• 700 & Above Employee

• SENIOR RECOVERY & TRIAGE DIRECTOR

  • Nov 1998 - Jun 2000

  Greater Nashville Area, TN • Responsible for gathering, compiling, and preparing data for monthly reports, creating, and implementing triage policies and procedures, coordinating and arranging board meetings, event management, keeping track record of all budget and database records for the call center, calendar management, and coordination of the workflow and performance evaluations among the call center staff. • Completed recruitment, interviewing, orientation, staffing, and development of the call center and… Show more • Responsible for gathering, compiling, and preparing data for monthly reports, creating, and implementing triage policies and procedures, coordinating and arranging board meetings, event management, keeping track record of all budget and database records for the call center, calendar management, and coordination of the workflow and performance evaluations among the call center staff. • Completed recruitment, interviewing, orientation, staffing, and development of the call center and recovery staff. • Hosted and coordinated weekly management meetings and teleconferences. • Responsible for the training and educating all triage coordinators and organ/tissue recovery staff. Show less



CarboMedics

• Canada
• Hospitals and Health Care

• REGIONAL PROJECT MANAGER/REGIONAL MEDICAL MONITOR

  • Sep 1993 - Nov 1998

  Greater Nashville Area, TN • Responsible for managing an oncology Phase II & III trial (managed and mentored 10 Regional CRAs and 2 Lead CRAs). • Accountable for the quality analysis and review of all visit reports while reviewing, answering, and triaging all data management queries and protocol violations. • Completed contract negotiations, budgeting, scheduling, and performance requirements and evaluations and ensuring all of the aforementioned items are being met. • Responsible for reviewing, designing… Show more • Responsible for managing an oncology Phase II & III trial (managed and mentored 10 Regional CRAs and 2 Lead CRAs). • Accountable for the quality analysis and review of all visit reports while reviewing, answering, and triaging all data management queries and protocol violations. • Completed contract negotiations, budgeting, scheduling, and performance requirements and evaluations and ensuring all of the aforementioned items are being met. • Responsible for reviewing, designing, implementing and approving one clinical protocol, data collection systems, and all clinical study documents (CRFs, transmittal logs, regulatory documents, IDB updates, etc.) for FDA submissions and study start-up. • Responsible for the study initiation visits: Conducted site initiation visits. Ensured completion of regulatory documents. Reviewed Investigator responsibilities. Coordinated shipment of study-related material. • Experienced with carrying out select internal site audits prior to FDA auditing. Show less