Experience

Antiva Biosciences, Inc.

• United States
• Biotechnology Research
• 1 - 100 Employee

• Chief Medical Officer

  • Sep 2023 - 4 months

  San Francisco Bay Area



Independent Consultant

• United States
• Technology, Information and Internet
• 1 - 100 Employee

• Self Employed

  • 2010 - Sep 2023

  Palo Alto, CA Providing customized consulting to biotechnology, medical device and healthcare IT companies. Examples of engagements have included serving as subject matter expert and providing interim senior leadership/strategic guidance/KOL recruitment and engagement for multiple development stage biotechnology and healthcare IT companies in the women’s/reproductive health therapeutic area; providing advice throughout different stages of product development for several healthcare IT companies; and… Show more Providing customized consulting to biotechnology, medical device and healthcare IT companies. Examples of engagements have included serving as subject matter expert and providing interim senior leadership/strategic guidance/KOL recruitment and engagement for multiple development stage biotechnology and healthcare IT companies in the women’s/reproductive health therapeutic area; providing advice throughout different stages of product development for several healthcare IT companies; and participating as a voting member of the Data Safety Monitoring Board (DSMB) and Clinical Events Committee (CEC) at Conceptus, Inc. (acquired by Bayer Healthcare in 2013) for a long-term clinical study of a gynecologic medical device. From May-September 2023, engaged as a clinical development consultant at Antiva Biosciences. Show less



Mirum Pharmaceuticals

• United States
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Vice President, Clinical Development and Medical Safety

  • Jan 2022 - May 2023

  Foster City, California, United States Promoted to this role as most senior physician on the leadership team, following departure of chief medical officer (CMO). Built two high-functioning teams (clinical development and medical safety - i.e., global drug safety/pharmacovigilance) over 2 years. Led cross functional teams in opening 3 INDs within one year and initiating global clinical studies across multiple indications within 9 months, including one first-in-pregnant-human indication (intrahepatic cholestasis of pregnancy, or… Show more Promoted to this role as most senior physician on the leadership team, following departure of chief medical officer (CMO). Built two high-functioning teams (clinical development and medical safety - i.e., global drug safety/pharmacovigilance) over 2 years. Led cross functional teams in opening 3 INDs within one year and initiating global clinical studies across multiple indications within 9 months, including one first-in-pregnant-human indication (intrahepatic cholestasis of pregnancy, or ICP). Clinical safety lead on EU MAA for maralixibat in the treatment of ALGS (approved December 2022) and supplemental NDA/EU Type 2 variation for PFIC indication expansion. Facilitated global commercial launches by transitioning from three PV vendors to a single global fit-for-purpose vendor in 3 months.

• Executive Director, Clinical Development and Medical Safety

  • Dec 2021 - Jan 2022

  Foster City, California, United States Upon departure of head of medical safety/CMO in November 2021, I assumed responsibility for global medical safety in addition to existing responsibilities for all volixibat clinical development programs.

• Executive Medical Director, Clinical Development

  • Feb 2020 - Dec 2021

  Foster City, California, United States Global clinical development lead for volixibat, an IBAT inhibitor under development for several cholestatic liver diseases including ICP, Primary Sclerosing Cholangitis (PSC) and Primary Biliary Cholangitis (PBC)

• Consultant, Clinical Development

  • Nov 2019 - Feb 2020

  Foster City, California, United States Acting clinical development lead for first-in-pregnant-human study of volixibat in Intrahepatic Cholestasis of Pregnancy (ICP)



Wildflower Health

• United States
• Hospitals and Health Care
• 1 - 100 Employee

• Medical Advisor

  • Jul 2012 - Jul 2022

  San Francisco Bay Area Initially reported to CEO as medical director; later served as a strategic advisor to venture-backed digital/mobile health company building a health engagement platform to improve healthcare quality and lower medical costs when people start families. Instrumental in the development and ongoing oversight of clinical content in "Due Date Plus", a novel smartphone app that helps patients optimally manage their pregnancies and promptly identify high risk pregnancies. Recruited four… Show more Initially reported to CEO as medical director; later served as a strategic advisor to venture-backed digital/mobile health company building a health engagement platform to improve healthcare quality and lower medical costs when people start families. Instrumental in the development and ongoing oversight of clinical content in "Due Date Plus", a novel smartphone app that helps patients optimally manage their pregnancies and promptly identify high risk pregnancies. Recruited four internationally renowned key opinion leaders (KOLs) in Maternal-Fetal Medicine to join company's Clinical Advisory Board. Worked directly with founders to evolve company's strategy for growth of initial product, as well as identify future possibilities for product pipeline. Show less



Myovant Sciences

• United States
• Biotechnology Research
• 200 - 300 Employee

• Consultant, Clinical Development

  • Aug 2018 - Jul 2019

  Brisbane, California Acting clinical development lead for the relugolix global phase 3 program for endometriosis associated pain (SPIRIT). Responsibilities included study design, protocol development and writing, medical monitoring, investigator training, strategic planning, development of relationships with KOLs, and oversight of CROs in conjunction with clinical operations team.



Menlo Therapeutics

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Consulting Senior Medical Director, Clinical Development

  • Dec 2016 - May 2018

  Menlo Park, California Reported directly to CMO. Clinical development lead for the serlopitant phase 2 psoriatic pruritus program. Responsibilities included study design, protocol development and writing, medical monitoring, investigator training, strategic planning, development of relationships with KOLs, and oversight of CROs in conjunction with clinical operations team.



Clovis Oncology

• United States
• Biotechnology Research
• 1 - 100 Employee

• Medical Director, Pharmacovigilance/Consultant

  • Sep 2015 - Dec 2016

  San Francisco Bay Area Reported directly to CMO as lead medical safety physician for the rucaparib ovarian cancer program; electively transitioned from FTE to consultant role in March 2016. Served as medical safety lead on cross-functional rucaparib NDA and EU MAA teams; initial NDA approved by FDA in Dec 2016 for BRCA+ ovarian cancer. Notable deliverables included initial draft USPI, summary of clinical safety (section 2.7.4.), clinical study reports, EU Risk Management Plan, and SmPC/PIL. Represented drug safety… Show more Reported directly to CMO as lead medical safety physician for the rucaparib ovarian cancer program; electively transitioned from FTE to consultant role in March 2016. Served as medical safety lead on cross-functional rucaparib NDA and EU MAA teams; initial NDA approved by FDA in Dec 2016 for BRCA+ ovarian cancer. Notable deliverables included initial draft USPI, summary of clinical safety (section 2.7.4.), clinical study reports, EU Risk Management Plan, and SmPC/PIL. Represented drug safety on the rucaparib NDA team in FDA Type C meeting. Day to day responsibilities included triage and medical review of ICSRs, periodic reports (e.g., DSURs), investigator brochures, informed consent forms and study protocols; responses to regulatory information requests; signal detection; support for pharmacovigilance (PV) operations team; mentorship of junior members of PV team. Show less



Dohmen Life Science Services (formerly BioSoteria)

• Medical Director, Pharmacovigilance

  • Jul 2013 - Sep 2015

  Emeryville, CA The Drug Safety division of Dohmen Life Science Services (DLSS) is a leading provider of contract pharmacovigilance (PV) operations and consulting services to many global biopharmaceutical client companies. I served as the Medical/PV lead for two of DLSS' s client companies; responsibilities included coordinating and leading cross-functional teams in order to meet/exceed strategic, operational and regulatory targets/goals. Additional responsibilities included triage, MedDRA coding… Show more The Drug Safety division of Dohmen Life Science Services (DLSS) is a leading provider of contract pharmacovigilance (PV) operations and consulting services to many global biopharmaceutical client companies. I served as the Medical/PV lead for two of DLSS' s client companies; responsibilities included coordinating and leading cross-functional teams in order to meet/exceed strategic, operational and regulatory targets/goals. Additional responsibilities included triage, MedDRA coding, medical review, and authoring/editing of narratives/medical comments/analyses of similar events (ASEs) for individual case safety reports, for investigational (Phase I-IV) and post-marketed compounds for 10+ biopharmaceutical clients; these companies operate variously within the US, EU, and Asia. I also contributed medical input and authored relevant sections within periodic reports (e.g. PADERs, DSURs, etc.) Therapeutic areas included oncology, endocrinology, anesthesiology, neurology (CNS), and reproductive health. Demonstrated proficiency with Argus Safety database. In conjunction with a world-class team of pharmacovigilance professionals, I also provided strategic risk management guidance to DLSS's client biopharmaceutical companies. Show less



LifeWave, Inc.

• Medical Equipment Manufacturing
• 1 - 100 Employee

• Consulting Chief Medical Officer

  • Dec 2012 - Jul 2013

  San Francisco Bay Area Provided leadership in clinical affairs for NIH funded/privately held medical device company that developed an ultra-wideband (UWB) impulse radar platform technology for non-invasive medical monitoring applications, initially including fetal heart rate and uterine contraction monitoring. Collaborated with CEO and Medical Advisory Board on corporate scientific strategy. Responsible for clinical study planning and execution, including site selection, study design, study protocol management, and… Show more Provided leadership in clinical affairs for NIH funded/privately held medical device company that developed an ultra-wideband (UWB) impulse radar platform technology for non-invasive medical monitoring applications, initially including fetal heart rate and uterine contraction monitoring. Collaborated with CEO and Medical Advisory Board on corporate scientific strategy. Responsible for clinical study planning and execution, including site selection, study design, study protocol management, and working with CROs to initiate and manage multi-site clinical studies. Show less



HiTouch Health

• Vice President, Business Development and Clinical Affairs

  • Sep 2012 - May 2013

  San Francisco Bay Area Reported directly to CEO of venture-backed health services company. Within first months of joining company, successfully led recruitment and signing of initial cohort of physicians to partner with company in providing an optional membership-based, concierge-type service to primary care patients. Responsible for sourcing >10 additional physicians in BD pipeline. Company’s initial product was developed for primary care; within first months of joining, identified a new, additional… Show more Reported directly to CEO of venture-backed health services company. Within first months of joining company, successfully led recruitment and signing of initial cohort of physicians to partner with company in providing an optional membership-based, concierge-type service to primary care patients. Responsible for sourcing >10 additional physicians in BD pipeline. Company’s initial product was developed for primary care; within first months of joining, identified a new, additional service area (OB/GYN) for company. In rapid development cycle, led CEO through version 1 of OB/GYN product ("Maternity Advocate"); remained subsequently engaged to provide ongoing product development leadership as the service evolved. Collaborated with CEO in the training of health advocates who directly interface with patients and provide care coordination, personalized wellness programs, and thorough follow-up after office visits. HiTouch Health was sold to Horizen Ventures and Softbank Holdings in 2013. Show less



Women's Care Medical Group

• United States
• Medical Practices

• Physician - OB/GYN

  • 2007 - 2012

  Redwood City, CA Practiced general OB/GYN in a small group private practice setting. Developed expertise in performing in-office hysteroscopic procedures, including diagnostic hysteroscopy, Novasure endometrial ablation, and Essure tubal sterilization with a high level of patient comfort and satisfaction. Invited by regional product managers to proctor/teach local OB/GYNs in the techniques of Novasure and Essure procedures. Specialized in vaginal ("incisionless") hysterectomy and daVinci robotically… Show more Practiced general OB/GYN in a small group private practice setting. Developed expertise in performing in-office hysteroscopic procedures, including diagnostic hysteroscopy, Novasure endometrial ablation, and Essure tubal sterilization with a high level of patient comfort and satisfaction. Invited by regional product managers to proctor/teach local OB/GYNs in the techniques of Novasure and Essure procedures. Specialized in vaginal ("incisionless") hysterectomy and daVinci robotically assisted laparoscopic surgery, particularly for patients with challenging anatomy/pathology. Performed first gynecologic surgery using daVinci robot at Sequoia Hospital. Appointed to Sequoia Hospital Robotic Surgery Steering Committee. Earned frequent referrals from other doctors and nurses, including many who referred themselves, their family members and friends. Guest speaker at Women’s Annual Health Conference, sponsored by Peninsula Urology, in 2010 and 2011. Guest speaker for Hologic on behalf of Novasure endometrial ablation device. Winner of Patients’ Choice Award 2008-2011 (www.patientschoice.org) Show less



The Permanente Medical Group

• Hospitals and Health Care
• 700 & Above Employee

• Physician - OB/GYN

  • 2003 - 2007

  San Jose, CA Practiced general OB/GYN within a large managed care, multi-specialty group.



Palo Alto Medical Foundation

• Hospitals and Health Care
• 1 - 100 Employee

• Physician - OB/GYN

  • 2002 - 2003

  Palo Alto, CA Practiced general OB/GYN within a large, high volume, multi-specialty group. Served as Voluntary Clinical Faculty at Stanford University School of Medicine, instructing residents and interns in OB/GYN.



Southern California Permanente Medical Group

• United States
• Hospitals and Health Care
• 1 - 100 Employee

• Physician - OB/GYN

  • 2001 - 2002

  Woodland Hills, CA Practiced general OB/GYN within a large managed care, multi-specialty group. Instructed UCLA OB/GYN residents in gynecologic surgery.



Los Angeles County/USC Medical Center

• United States
• Medical Practices
• 1 - 100 Employee

• Resident Physician - OB/GYN

  • 1997 - 2001

  Los Angeles, CA Completed OB/GYN residency at an academic medical center serving a high risk, indigent, predominantly Spanish speaking population. Assisted attending physicians in execution of clinical trials for drugs and medical devices. Learned Spanish on the job and eventually became a Los Angeles County certified Spanish translator. Won the Wyeth Resident Reporter award as a 3rd year resident.