Drug development expert in the healthcare sector, consistently delivering successful outcomes for midsize and boutique biotechnology firms, CROs, and large pharmaceutical companies. With a proven track record in leading clinical development programs, managed projects from preclinical stages through early, mid, and late-phase clinical trials.
Experienced with clinical oversight, strategic planning, and team leadership. Utilizes regulatory compliance knowledge to ensure high standards of patient care. Track record of fostering collaborative environments and driving impactful results. Experienced medical leader with proven track record in driving clinical excellence and operational efficiency. Skilled in strategic planning, regulatory compliance, and patient-centered care. Strong focus on team collaboration, adaptable to changing needs, and results-driven. Known for building reliable teams and delivering impactful healthcare solutions.
Overview
31
31
years of professional experience
1
1
Certification
Work History
Senior Medical Director
CRISPR Therapeutics
San Francisco, CA
2019 - Current
Led clinical development programs for multiple assets, providing CPD, clinical, medical, and scientific strategy
Spearheaded Targeted Protein Degradation (TPD) programs, targeting and degrading protein
Engaged with the US FDA, filed INDs, and initiated clinical studies
Reviewed material used by medical team as part of Medical Review Board standards.
Reviewed Statistical Analysis Plans (SAPs), including interim analysis plans, stopping rules, and randomization schemes, while assessing protocol amendments as needed
Directed medical oversight for key clinical programs
Led initiatives focused on individualized treatment regimens, biomarkers, and companion diagnostics
Reviewed interim data, assessed publications, and presented findings at clinical study sites and investigator meetings after site activation
Evaluated clinical trial patient recruitment, retention, protocol adherence, and data quality to ensure timely completion of trials, advancing programs to mid-stage clinical studies
Monitored recruitment progress, data collection, case narratives review, query resolution and data lock.
Conducted thorough risk assessments for various scenarios, implementing mitigation strategies as needed.
Developed strategic partnerships with key external stakeholders.
Improved patient outcomes managing CST and IIT & IST strategy.
In collaboration with cross function leads, reduced overall costs while maintaining high-quality standards by optimizing resource allocation and utilization within the departments.
Vice President, Drug Development
Sumitomo Pharma Co., Ltd
Marlborough, MA
2017 - 2019
Worked closely with operation, quality control, regulatory affairs departments
Assessed educational needs and developed strategies for internal/external trainings and engagements
Monitored patients in Phase I/II clinical trials as a core member of the clinical development and product safety teams
Trained study site staff, Monitored eligibility, Medical Monitoring, etc
Reviewed the final draft TFLs according to SAP, presented the data to the upper management
Prepared and finalized synopses of clinical study protocols, investigator brochures, regulatory documents, and related clinical documents
Immunotherapy, Small and large molecules, TA: Hematology, IO
Demonstrated strong organizational and time management skills while managing multiple projects.
Learned and adapted quickly to new drug application and FDA approval.
Executive Medical Director
AMGEN – ONYX, An AMGEN Subsidiary
South San Francisco, California
2012 - 2016
Managed all aspects of Clinical Development Programs at ONYX / AMGEN before and after M&A (Onyx became An AMGEN Subsidiary)
Managed cardiac toxicity associated with the Investigational Medicinal Product (IMP) during ODAC and after product approval
Launched 2 BTD products after accelerated FDA approval based on positive Phase 2 PFS data for KYPROLIS and BLYNCYTO
Led investigator meetings and lead site initiation visits with clinical trial investigators
Interacted with clinical investigators and thought leaders, Key Opinion Leaders (KoLs)
Ensured completion of pivotal study recruitment as designated monitor
Led the development of safety sections, including Reference Safety Information, in the Investigator Brochure
Contributed to the product launch Plan (PLP) based on robust overall survival data from phase 2 (PFS) & Phase 3 (OS) clinical studies
Developed, improved, and implemented processes for signal detection, signal management, and benefit-risk evaluation
Led label negotiation during accelerated approval activities for Blincyto (ALL) and Kyprolis (multiple myeloma)
Developed strategic plans and initiatives for the organization''s growth, ensuring long-term financial sustainability and operational excellence
Discussed potential subject eligibility and protocol deviations
Ensured completion of pivotal study recruitment as designated monitor
Participated in cross-functional monitoring of pivotal post-marketing trial data as a core member of the safety team
Translated findings from research and nonclinical studies into clinical development opportunities
Analyzed industry trends and tracked competitor activities to inform decision making.
Interacted with clinical investigators and thought leaders
Composed Study Synopsis as well as full protocols, investigator brochures, clinical study reports
Conducted investigator meetings and lead site initiation visits with clinical trial investigators
Developed and maintained relationships with KOLs to deliver high value presentations
Oversaw divisional marketing, advertising and new product development.
Facilitated knowledge exchange among peers through regular conferences, seminars, workshops, ultimately elevating the standard of care across the organization.
Mentored junior physicians and staff members, cultivating a culture of continuous learning and professional development within the organization.
Devised and presented business plans and forecasts to board of directors.
Represented organization at industry conferences and events.
Established and maintained strong relationships with key opinion leaders, investigators, and strategic partners.
Senior Medical Director
Abbott
San Francisco, California
2010 - 2012
Assumed roles and responsibilities of program lead for assigned projects
As a core member of clinical development team and product safety team, monitored study conduct of multiple mid and late-stage clinical trials
Represented the company sub-teams during scientific meetings and presentations
Filed NDA (ISS & ISE)
Composed clinical study synopsis and full protocols
Led mid/late-stage clinical development programs
Reviewed the SAP, including the interim analysis plan, stopping rules and randomization scheme
Reviewed and considered any protocol modifications
Composed CSRs of completed clinical studies
Attended and provided medical expertise and support for meetings with study investigators
Developed and managed relationships with key opinion leaders for clinical programs and patient enrollments
Interacted with FDA and international regulatory authorities
Led internal and external scientific communications
Developed and executed clinical development strategies and alignments
Led medical and scientific clinical development activities
Conducted investigator meetings (IM) and led site initiation visits with clinical trial investigators
Developed contingency plans, provided technical and strategic advice
Ensured queries were sent and subject was followed-up until event resolution
Led product life cycle management activities with Abbott affiliates in global level (sNDA)
Attended TC weekly and ad-hoc meetings with ABP medical monitor of the sponsor
Led cross-functional meetings and provided continuous support
Training of the staff and external teams for updates regarding Safety Excellence
Improved patient outcomes by developing and implementing innovative treatment protocols.
Spearheaded process improvements that resulted in increased efficiency within department operations.
Successfully negotiated client contract renewals
Supervised clinical staff, providing continuous professional development opportunities and training.
Medical Director, Program Lead
Neurocrine Biosciences
01.2007 - 01.2009
TA: Women and Men's Health, CNS
Led medical monitoring responsibilities for phase 1 and 2 clinical studies for GnRH antagonist programs
As a core member of clinical development team (CDT) and product safety team (PST), monitored patients enrolled during Phase I a/b and 2 a/b clinical trials for 2 assigned products
Composed protocols, investigator brochures, clinical study reports and reviewed clinical trial documents
Conducted investigator meetings and led site initiation visits with clinical trial investigators
Executed and deployed clinical development strategic plans
Developed contingency plans, provided technical and strategic advice
Evaluated incoming safety information, ICSR narrative and reporting of AE
Ensured clinical study timelines, milestones and budgets are met
Provided medical monitoring to multiple oncology clinical trials
Led project teams to design and implemented clinical studies
Reviewed SAEs, SUSARs narratives, analyses of similar events
Ensured queries were sent and subject was followed-up until event resolution
Worked in a team environment comprising clinical operations, biomarker specialists, CROs, and regulatory affairs
Translated findings from research and nonclinical studies into clinical development opportunities
Interacted with Key Opinion Leaders and clinical study sites (investigators and study coordinators)
Worked with internal regulatory affairs team and other ethical guidelines relevant to the industry
Scientists, business and commercial organizations in a cross functional matrix environment
Designed clinical studies, Composed Clinical Study Synopsis and full Protocols
Ensured timely study completion and data read/reported
Led co-development activities with ABP (Pfizer and Abbott)
Analyzed incoming safety information from phase 1 - 3 clinical studies
Ensured compliance
Associate Medical Director
OSI Pharmaceuticals, Now Takeda
01.2004 - 01.2007
Clinical Research and Development for all TKI programs
TA: Oncology, Solid tumors, Multiple Sclerosis, Ophthalmology, Women and Men's Health
Performed Medical Monitor tasks for the assigned products
Assumed roles and responsibilities of program lead for assigned projects
Documented and resolved [Issue] which led to [Results].
Achieved [Result] by completing [Task] with accuracy and efficiency.
Achieved [Result] through effectively helping with [Task].
Collaborated with team of [Number] in the development of [Project name].
Supervised team of [Number] staff members.
Achieved [Result] by introducing [Software] for [Type] tasks.
Used Microsoft Excel to develop inventory tracking spreadsheets.
Resolved product issue through consumer testing.
Presentations
An Open-label, Long-term Safety Study of Linaclotide in Patients with Chronic Constipation or Irritable Bowel Syndrome with Constipation
Randomized, Double-Blind, Dose-Range-Finding, Phase 2 Study of Linaclotide Administered to Patients With IBS-C
Phase III, Randomized, Double-Blind, Placebo-Controlled, Trial of Linaclotide Administered to Patients with Chronic Constipation
Active, not recruiting An Efficacy and Safety Study of NBI-56418 in Endometriosis Conditions: Endometriosis; Pain, Interventions: Drug: NBI-56418; Drug: NBI-56418; Drug: placebo
Recruiting Efficacy and Safety Study in Endometriosis With NBI-56418; Placebo and Active Controlled Condition: Endometriosis, Intervention: Drug: NBI-56418 or placebo tablet; leuprorelin or placebo injection
Active, not recruiting Safety and Efficacy Study of NBI-56418 in Endometriosis Condition: Endometriosis, Interventions: Drug: NBI-56418; Drug: depo-subQ provera 104
Completed Endometriosis Trial: Study of NBI-56418 in Endometriosis Condition: Endometriosis. Intervention: Drug: NBI-56418 (GnRH antagonist)
RADIANT: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Single-Agent Tarceva (Erlotinib) Following Complete Tumor Resection with or without Adjuvant Chemotherapy in Patients with Stage IB-IIIA Non–Small-Cell Lung Carcinoma Who Have EGFR- Positive Tumors by Either FISH or IHC
Randomized double blind Clinical trial to Evaluate 3 Dosages of Third Generation of Progestagen After 28 Days Administration in Healthy Postmenopausal Women
Multicenter Clinical Trial of the efficacy and tolerability of a novel desogestrel OAC
Imani, R et al, AACR 2016: Clinical pharmacokinetics and pharmacodynamics of ME- 401, an oral, potent and selective inhibitor of phosphatidylinositol 3-kinase, following single ascending dose administration to healthy volunteers.
A Randomized, Double-Blinded, Placebo-Controlled, Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of XmAb7195.Poster Discussion Session, ATS 2016, San Francisco, CA, Paul Foster and Robert Imani
Imani, R; D Thai-Cuarto; R Jimenez R, J Burke, R Kroll, C O’Brien. PETAL Study: Safety, Tolerability and effectiveness of Elagolix, an Oral GnRH antagonist for endometriosis.
American Society for Reproductive Medicine (ASRM) 2009, Atlanta, GA. poster presentation in 2009.
Imani, R; Jimenez, R.; Burke, J.; Akright, B.; Koltun, W.; O’Brien, C. Endometriosis Recruitment Methodology and Patient Baseline Characteristics in Clinical Trials. Endocrine Society for Human Reproductive Endocrinology (ESHRE), Amsterdam, the Netherlands. Submitted for oral or poster presentation in 2009.
O’Brien, C, Jimenez, Imani, R; R.; Burke, J.; Dmowski, WP. Elagolix, An Oral GnRH antagonist For Endometriosis, Has Minimal Impact On Bone Mineral Density. Endocrine Society's Annual Meeting (ENDO 09), Washington, DC, June 10-13, 2009. Accepted.
Imani, B; Prediction of chances to conceive in normogonadotropic oligo-amenorrheic infertile patients following clomiphene citrate induction of ovulation. Reinier de Graaf Symposium, Noordwijk, The Netherlands, 26-28 September 1996.
Imani, B; Predictive value of initial screening in patients with cycle abnormality and infertility. Fertility weekend of Dutch and Belgium gynecologists, Antwerp, Belgium, May 16-17, 1998.
Imani, B; Prediction of response (ovulation versus conception) in patients treated with clomiphene citrate. Presentation at EMCR, The Netherlands, September 29 1998.
Imani, B; Discrepancies in predictors of ovulation and conception following clomiphene citrate induction of ovulation in normogonadotropic oligo-amenorrheic infertility. 16th World Congress on Fertility and Sterility and the 54th Annual Meeting of the American Society for Reproductive Medicine, San Francisco, California, USA. October 3-9, 1998.
Imani, B; Prediction of chances to conceive in normogonadotropic oligo-amenorrheic infertile patients following ovulation induction modalities. Anno 2000 summer symposium, Rotterdam, The Netherlands, July 26 2000.
Symposia: Organon Symposium on Steroida; Contraception, B. Imani, Herjan Coelingh Bennink, Fauser BCJM
Ferring Symposium Program, July 1996, Auditorium 1. How to Categorize patients with multicystic ovaries, Fauser BCJM, Imani B, van Santbrink E.J.P
Predictors of Chances to Conceive in Ovulatory Patients during Clomiphene Citrate Induction of Ovulation in Normogonadotropic Oligoamenorrheic Infertility, Section of Reproductive Endocrinology and Fertility, Department of Obstetrics and Gynecology, Dijkzigt Academic Hospital and Erasmus University, Rotterdam, the Netherlands
High singleton live birth rate following classical ovulation induction in normogonadotrophic anovulatory infertility (WHO 2) FSH response–dose can be predicted in ovulation induction for norm gonadotropic an ovulatory infertility
References
Two references available upon request
Affiliations
ABC
Certification
Board Certified in Healthcare Management (BCHM) - American College of Healthcare Executives.
Certified Medical Manager (CMM) - Professional Association of Health Care Office Management.
Project Management Professional (PMP) – Project Management Institute.
Certified Risk Manager In Healthcare(CRMH)Global Risk Community.
Lean Six Sigma Green Belt Certification (LSSGB) – International Association for Six Sigma Certification.
Master Certified Health Education Specialist (MCHES) – National Commission for Health Education Credentialing.
Registered Health Information Administrator (RHIA) - American Health Information Management Association.
Health Care Compliance Certification Program Certificate Holder(HCCP)- Compliance Certification Board.
Certified Healthcare Facility Manager (CHFM) - American Hospital Association.
Certified Nursing Home Administrator (CNHA) – National Association of Long Term Care Administrator Boards.
Licensed Independent Clinical Social Worker(LICSW)State specific licensure boards.
Diplomate in Clinical Social Work(DCSW)American Board Of Examiners In Clinical Social Work.
Certified Professional in Healthcare Quality (CPHQ) - National Association for Healthcare Quality.
Certified Medical Practice Executive (CMPE) - American College of Medical Practice Executives.
Nurse Executive, Advanced-Board Certified (NEA-BC) - American Nurses Credentialing Center.
Fellow of the American College of Healthcare Executives (FACHE) - American College of Healthcare Executives.
Certified In Public Health(CPH)National Board Of Public Health Examiners.
Fellow in the American Academy of Project Management (FAAPM) - American Academy of Project Management.
[Name of Certification] [Issuing Organization] [Year Month]
Senior Research Associate - Technical Operations at CRISPR Therapeutics Inc.Senior Research Associate - Technical Operations at CRISPR Therapeutics Inc.
Sr. Manager, Regulatory Systems Business Support, Regulatory Operations at CRISPR Therapeutics Inc.Sr. Manager, Regulatory Systems Business Support, Regulatory Operations at CRISPR Therapeutics Inc.