Role: Deputy Site Head Product Development Oncology @ Genentech
Senior Clinical Scientist - Oncology @ Genentech
Clinical Scientist-Oncology @ Genentech
BS, Biology @
Indiana University Bloomington
I am a clinical and academic research professional with background in clinical trial programs in a variety of indications with over ten years of experience. In the industry setting I have supported clinical trials programs as a cross-functional team leader in oncology indications such as solid tumor, breast cancer, melanoma, and lymphoma as well as studies with
I am a clinical and academic research professional with background in clinical trial programs in a variety of indications with over ten years of experience. In the industry setting I have supported clinical trials programs as a cross-functional team leader in oncology indications such as solid tumor, breast cancer, melanoma, and lymphoma as well as studies with anti-cancer therapeutics in healthy subjects. My Ph.D. in Cancer Biology through the Pathobiology and Molecular Medicine program was highly focused on translational research and clinical application. In addition to my graduate concentration in Oncology, my training included diverse research experience in Infectious Diseases, Cardiovascular/Lipid Disorders, Immunology, and Endocrine/Metabolic Disorders. I have contributed to early phase studies (I and II) as well as phase III registrational studies and post marketing commitments. I have an extensive understanding of molecular biology and a broad knowledgebase of clinical development in small molecules, monoclonal antibodies, and biologics.
Role: Deputy Site Head Product Development Oncology @ -Develop the local PDO community, cross-PD partnerships, & foster engagement
-Represent PDO (and PDC) at the Site Leadership Team and act as an engaged member to ensure functional representation and that best practices are developed and disseminated across the site
-Be a credible and accessible leader for PDO employees
-Ensure that site focus and activities are aligned with overall PDO vision and objectives while also addressing local needs
-Facilitate relationships with other local and global Roche functions and groups
-Support two-way communication with colleagues and leadership
-Participation in multiple initiatives inluding:
*Support of on-boarding of new colleagues and provide mentorship
*Participation in the SSF Site Innovation Group with the goal of, "Supporting a culture of creative confidence where innovation belongs to everyone."
*Support and participate in initiatives for partnerships with Early Clinical Development and Product Development
*Collaborate in cross functional and information sharing-process initiatives From May 2015 to Present (6 months) Senior Clinical Scientist - Oncology @ As a clinical scientist I support clinical trials associated with the exploratory development of novel anti-cancer agents within the Genentech portfolio. From 2015 to Present (less than a year) Clinical Scientist-Oncology @ Primary Responsibilities:
Participate in competitive intelligence and/or other market/industry assessment activities
• Collaborate with safety science in development of safety narratives and other safety-related documentation
• Develop clinical presentations and other materials for internal/external meetings and communications with Health Authorities
• Participate in ongoing enhancements/development of team processes and other resources
• Where assigned, act as the primary clinical development point-of-contact from the team for medical monitor inquiries from operations, (CROs), etc.
• Respond to questions from other internal and external parties regarding studies and programs
• Conduct clinical review of study data; evaluating data trends, outliers, etc. in order to communicate relevant medical inquiries
• Participate in safety meetings and analyze potential safety events
• Review and analyze clinical study reporting documents
• Maintain study protocol/ICF amendments and works with other groups to ensure the timely and appropriate completion of protocol amendments
• Assist PD Medical Directors in responding to HA inquiries
• Deliver key presentations, both internally and externally, to convey the clinical development perspective and provide strategy updates
• Write and review abstracts, posters, content for scientific meetings, conferences, other events and presentations, and other publicly distributed materials and coordinates further reviews with internal partners and stakeholders From October 2012 to March 2015 (2 years 6 months) San Francisco Bay AreaClinical Research Operations Strategy Lead @ As a CROSL I worked to integrate scientific and operations expertise for the translation of clinical development plans to clinical trial conduct in early phase clinical studies for multiple indications in pharma and biotherapeutics. I worked closely with the operational and clinical teams to provide a collaborative and efficient team environment with the ultimate goal of designing, conducting, and completing quality early phase clinical trials in a timely and effective manner. From September 2011 to October 2012 (1 year 2 months) Cambridge,MAClinical Study Manager Biotherapeutics @ My primary function as a clinical study manager in support of biotherapeutics was to contribute to Phase I and II clinical trials through active management of trial activities in all study aspects to ensure timely delivery of quality data in a variety of therapeutic areas including oncology, ulcerative colitis, and acromegaly. From June 2010 to September 2011 (1 year 4 months) Cambridge, MAGlobal Lead Clinical Research Associate (Oncology) @ My primary role as a Lead Clinical Research Associate (CRA) was to ensure
high quality site management and proper protocol specific training for the
conduction of Phase II-III clinical trials in oncology. My focus as a Lead CRA
was to maintain awareness of issues, promote communication, and supply
appropriate training on the CRO and site level in accordance with program
requirements. From November 2008 to May 2010 (1 year 7 months) Graduate Research @ (02/05 –11/08) Graduate Dissertation Research
Mentor: Dr. Kathryn Wikenheiser-Brokamp, M.D. Ph.D.
Cincinnati Children’s Hospital Medical Center/ University of Cincinnati, Pathology and Laboratory Medicine and Pulmonary Biology
The objective of my dissertation project was to elucidate the role of the
retinoblastoma (Rb) tumor suppressor in lung epithelial regeneration after injury utilizing a clinically relevant genetically engineered mouse model.
(10/04 - 01/05, 1/04 - 3/04) Graduate Research Rotation
Mentor: Dr. Judith Rhodes, Ph.D.
University of Cincinnati, Dept. of Pathology and Laboratory Medicine
The objective of my research rotation was to determine the susceptibility of stress on Aspergillus fumigatus mutants lacking the genes for regulatory or catalytic subunits of protein kinase A.
(07/04 - 09/04) Graduate Industrial Research Rotation
Mentor: Dr. George Sabatakos, Ph.D.
Proctor and Gamble Pharmaceuticals
The objective of my industrial research rotation was to investigate the role of osteogenic growth peptide in osteoblast differentiation utilizing murine and human cell lines.
(06/03 - 08/03) Graduate Research Rotation
Mentor: Dr. Melanie Cushion, Ph.D.
University of Cincinnati, Dept. of Pathology and Laboratory Medicine
The objective of my research rotation was to elucidate the mechanisms underlying pulmonary clearance of Pneumocystis carinii. Specifically, I examined the role of cytokines in the setting of surfactant protein-A (SP-A) and Toll-Like Receptor 4 (TRL4) deficiency on Pneumocystis carinii clearance utilizing knock out mouse models and RT-PCR technology.
(08/01 - 05/02) Undergraduate Research Assistant
Mentor: Dr. Charles Baer, Ph.D.
Indiana University, Dept. of Biology
I participated in collecting data for a population genetics study that analyzed mutation accumulation rates and the effects of new mutations on genetic fitness in the nematode Caenorhabditis elegans. From July 2003 to November 2008 (5 years 5 months) University of CincinnatiResearch Presentations and Invited Speaking Engagements @ (3/2012) Invited Speaker. Maximizing Clinical Operations in Phase I-III Studies Conference. Topic: Optimizing Early Phase Clinical Trials to Accelerate Proof of Concept and Transition into Late Stage Research, Q1 Productions
(11/2008) Dissertation Defense. “Retinoblastoma(Rb) is a critical regulator in the lung epithelium”, Univ Cincinnati
(6/2008) Graduate Lecturer, Topic: Cancer and Inflammation Course: Immunology of Disease, Univ Cincinnati
(7/2007) Poster Session. “Retinoblastoma (Rb) function is essential for establishing lung epithelial quiescence after injury but is dispensable for normal homeostasis”, The Edward A. Smuckler Memorial Pathobiology of Cancer Workshop
(4/2007) Poster Session. “Retinoblastoma (Rb) function is essential for establishing lung epithelial quiescence after injury but is dispensable for normal homeostasis”, AACR
(11/2006) Invited Speaker. “Pathobiology and Molecular Medicine Graduate Programs: The Importance of Lung Cancer Research”, Undergraduate Biology Club Career Symposium, Miami University
(5/2006) Poster Discussion Session. “Retinoblastoma Protein Regulates Lung Epithelial Repair After Injury”, American Thoracic Society
(2/2006) Oral Presentation. “The Role of the Retinoblastoma Protein in the Repairing Lung Epithelium”, UC
(10/2005) Poster Presentation. “The Retinoblastoma Protein (Rb) Regulates Lung Epithelial Repair After Injury”, Graduate Student Research Forum, UC
(9/2004) Oral Presentation. “Analysis of an in vitro Model for the Role of Osteogenic Growth Peptide in Osteoblast Differentiation” Univ Cincinnati
(8/2004) Oral Presentation. “Analysis of an in vitro Model for the Role of Osteogenic Growth Peptide in Osteoblast Differentiation”, P&G Pharma
(5/2004) Oral Presentation. “Aspergillus fumigatus and Stress Response in the PKA Knock Out System” , Univ Cincinnati
(10/2003) Oral Presentation. “Clearance of Pneumocystis carinii in SP-A Knockout and TLR 4 Deficient Mice” ,Univ Cincinnati From January 2003 to November 2008 (5 years 11 months)
Ph.D., Pathobiology and Molecular Medicine @ University of Cincinnati From 2003 to 2008 BS, Biology @ Indiana University Bloomington From 1998 to 2003 Nicole Richie is skilled in: Clinical Trials, Molecular Biology, Clinical Development, CTMS, Oncology, Translational Medicine, Infectious Diseases, Clinical Research, CRO, Immunology, Pharmacokinetics, FDA, GCP, Drug Development, Drug Discovery, Medicine, Therapeutic Areas, Regulatory Submissions, Protocol, Pharmaceutical Industry, Biotechnology, Life Sciences, Biopharmaceuticals, ICH-GCP, SOP, EDC, Pharmacovigilance
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