Manager Clinical

Caroline W. Cardin

Email: j6ecxw@r.postjobfree.com

Phone: 513-***-****

Objective:

I am seeking opportunities for my home based toxicology and clinical research consulting business. I am interested in securing a home based clinical position that will utilize my extensive experience in managing and delivering on pre-clinical and global clinical programs, clinical methodology development, protocol development, monitoring of studies, reporting of clinical findings and preparation of registration packages to support regulatory and product claims for billion dollar brands for the Procter and Gamble Company.

Relevant Qualifications:

Technical Expertise: Pre-clinical and global clinical programs in multi-therapeutic areas to include gastrointestinal tract (GI), respiratory, obesity and weight loss, hair re-growth, antidandruff, anti-lice, anti-acne, skin aging, sunscreen protection, and women’s health. Experienced in pre-clinical studies, human safety hazard endpoints and human safety risk assessments. Experienced in the preparation of toxicology and clinical sections for FDA IND-NDA submissions, annual reports and global registration packages. Experienced in the development of IT systems and platforms with IT partners aimed at accessing and retrieving data and reports. Knowledgeable in systems and platforms used in the acquisition and analyses of data generated from clinical trials (for example, imaging and image analyses). Knowledgeable in clinical statistical methods.

Interpersonal: Interacted with large diverse groups across all business hierarchies within and outside the company including thought leaders, investigators and CRO personnel to deliver successful timely clinical trials to support registration timing and product claims.

Organizational: Mentored and trained junior CRA’s and Asian Americans (especially women) at the Procter and Gamble Company. Asian American Diversity leader - envisioned and co-developed diversity programs targeted at developing and retaining Asian Pacific American talent at the Procter and Gamble Company.

Professional Experience:

Current Position: Founder of Home based consulting business Pacific Toxicology and Clinical Research LLC (2010 to present). Toxicology consultant involved in the review and summarization of registration packages on chemicals from the European REACh Chemical consortia.

Past Positions: Principal Scientist: Professional and Regulatory Services, Regulatory and Clinical Development or Central Product Safety Departments of the Product Procter & Gamble and Company. (1974 to 2010).

Manager of pre-clinical and clinical programs with primary responsibilities for projecting and managing budget, relationship management with CROs, external consultants and IRB’s; oversight of clinical programs to ensure that trials are completed successfully in a timely manner and within the projected budget; interface with internal functions such as clinical data management, statistics, product development to deliver on clinical program, writing clinical protocols, clinical reports and sections pertaining to clinical for IRB and regulatory submissions; met with regulatory agencies to discuss aspects of the clinical sections in IND’s/NDA’s. Responsible for the training and work output of clinical research associates monitoring the clinical trials including participation in the monitoring studies at startup, interim and closeout. Data from these trials supported global registrations and product claims. Successful in delivering on global clinical programs with trials conducted in US, UK, France, Canada, Japan, China, Thailand, India, Brazil, Panama and Madagascar.

Manager of internal CRO Clinical Trials Facility for Personal Health Care with responsibility for internal and contract medical personnel and the clinical studies conducted at this Clinical Trials Facility on OTC Personal Health Care Products.

Experienced in the scientific and regulatory scenarios for multiple therapeutic areas to include gastrointestinal tract (GI), respiratory, obesity and weight loss, hair re-growth, antidandruff, anti-lice, anti-acne, skin aging, sunscreen protection, and women’s health.

Experienced in writing the toxicology and clinical sections of FDA IND-NDA submissions, annual reports and global registration packages to support regulatory requirements supporting the marketing of billion dollar brands of the Procter and Gamble Company.

Experienced in pre-clinical studies, human safety hazard endpoints and human safety risk assessments.

Conceptualized and co-developed IT tools to enable external consulting groups to work seamlessly on REACh robust summaries on a 24 hour basis. Co-developed tools to store and recall pre-clinical toxicological study information so that it can be easily utilized for submissions.

Supervised and/or trained groups of external consultants in US and India to summarize pre-clinical and clinical safety studies by endpoint on chemicals for the Procter and Gamble Company into IUCLID5 registration packages for timely data call-in for REACh submissions. Familiar with REACH regulations and IUCLID5 software packages, including robust human safety study endpoints, Chemical Safety Reports, Chemical Safety Assessments, and exposure scenarios.

Corporate Functions site diversity leader (2005 to 2009), Health Care and Beauty Care diversity leader (1999 to 2005) on the Asian Pacific American R&D Leadership Team. Envisioned and co-developed diversity programs to include Mutual Empowerment - Managers as Partners, Embassy event, Career Chats and mentoring programs targeted at developing Asian Pacific American talent at the Procter and Gamble Company.

Skin and Hair Science Community of Practice Steering Team member. Clinical Steering Committee Team member. Organized and chair training sessions and clinical symposium sessions on GCP, ICH guidelines

Current Position:

Founder of Home based consulting business: Pacific Toxicology and Clinical Research LLC (2010 to present). Toxicology consultant - Reviewed and summarized REACh registration packages on chemicals from the European REACh Chemical consortia associated the registration, and authorization of chemicals for the European Union.

Past Positions and Areas of Expertise:

Principal Scientist for the Procter and Gamble Company with 35 years of experience in the field of toxicology and clinical research. Managed toxicology and/or clinical programs, had responsibility for delivering on pre-clinical and clinical studies required to support product registrations and marketing claims. Collaborated with regulatory and wrote the toxicology and clinical sections of FDA IND-NDA submissions, annual reports and global registration packages. Experienced in pre-clinical studies, human safety hazard endpoints and human safety risk assessments. Experienced in the management of clinical program (Phases I to III) with large base human trials placed in US, Canada, Asia, and Latin America. The focus areas included gastrointestinal tract (GI), respiratory, obesity and weight loss, hair re-growth, antidandruff, anti-lice, anti-acne, skin aging, sunscreen protection and women’s health. Manager of an internal off-site clinical trials facility (CRO) staffed by both internal and external medical staff involved in the conduct of clinical studies for Procter and Gamble’s Health Care Sector. A summary of my experience is as follows:

1. Principal Scientist - Regulatory, Clinical Research and Data Management Department and Human Toxicology Central Product Safety Department (1998 to 2010). Successful in delivering on global clinical programs with trials conducted in US, UK, France, Canada, Japan, China, Thailand, India, Brazil, Panama and Madagascar. This role was the program manager with primary responsibilities for projecting and managing budget, relationship management with CROs, external consultants and IRB’s; oversight of clinical program to ensure that trials are completed successfully in a timely manner and within the projected budget; interface with internal functions such as clinical data management, statistics, and product development to deliver on clinical programs; writing of clinical protocols, clinical reports and sections pertaining to clinical for IRB and regulatory submissions; and met with regulatory agencies to discuss aspects of the clinical sections in IND’s/NDA’s. Responsible for the training and work output of clinical research associates monitoring the clinical trials including participation in clinical monitoring of studies when required. Data from these trials supported global registrations and product claims of billion dollar brands for the Procter and Gamble Company. Manager of internal CRO Clinical Trials Facility for Personal Health Care (2000 to 2002) with responsibility for internal and contract medical personnel and clinical studies executed in this Clinical Trials Facility for OTC Personal Health Care Products. Conceptualized and co-developed IT tools to enable external consulting groups to work seamlessly on REACh robust summaries on a 24 hour basis. Co-developed tools to store pre-clinical toxicological study information on REACh submissions so that it can be recalled easily. Supervised and/or trained groups of external consultants in US and India to summarize pre-clinical and clinical safety studies by endpoint on chemicals into IUCLID5 registration packages for timely data call-in for REACh submissions for the Procter and Gamble Company. Experienced in REACH regulations and IUCLID5 software packages, including robust human safety study endpoints, Chemical Safety Reports, Chemical Safety Assessments, and exposure scenarios.

2. Senior Scientist - Professional and Regulatory Services Department (1986 to 1998) – responsible for Human safety and Clinical Research programs for the Beauty Care sector. Managed Head and Shoulders antidandruff and hair re-growth pre-clinical IND/NDA programs. Prepared IND/NDAs and global registration submission packages (safety sections and/or clinical sections) and annual reports for Head and Shoulders, hair re-growth, anti-acne and anti-lice programs. Monitored both human safety pre-clinical and clinical studies.

3. Senior Scientist - Professional and Regulatory Services Department (1980 to 1986): responsible for pre-clinical programs to support hair care, skin care, antiperspirant and deodorants, feminine care, fabric care or dish care products. Responsible for Phase IV Reporting of adverse reactions to FDA for the Beauty Care Sector. On call (24 hours) to University of Cincinnati poison control center.

4. Scientist - Professional and Regulatory Services Department (1974 to 1980): managed environmental and pre-clinical toxicology programs for fabric care and dish care and feminine protection sectors. Managed the clinical skin laboratory responsible for conducting human skin sensitization studies.

5. Corporate Functions site diversity leader (2005 to 2009), Health Care and Beauty Care diversity leader (1999 to 2005) on the Asian Pacific American R&D Leadership Team. Envisioned and co-developed diversity programs to include Mutual Empowerment - Managers as Partners, Embassy event, Career Chats and mentoring programs targeted at developing Asian Pacific American talent at the Procter and Gamble Company.

6. Skin and Hair Science Community of Practice Steering Team member. Clinical Steering Committee Team member. Organized and chair training sessions and clinical symposium sessions on GCP, ICH guidelines.

Scientific Publications:

1. Dawson T, Cardin CW, Schwartz JR. Dandruff and Seborrheic Dermatitis. Chapter in Baran and Maibach. Cosmetic Dermatology, 4th Edition. 2011.

2. Cardin CW, Schwartz JR, Dawson T. Dandruff and Seborrheic Dermatitis. Chapter in Baran and Maibach. Cosmetic Dermatology, 3rd edition, 2004.

3. Cardin CW. Clinical Methods in Assessing Hair Re-growth in Androgenetic Alopecia. Book Chapter in Baran and Maibach. Cosmetic Dermatology, 3rd edition, 2004.

4. Mills O Jr., Thornsberry C., Cardin CW, Smiles KA, Leyden JJ. Bacterial resistance and Therapeutic Outcome following Three Months of Topical Acne Therapy with 2% Erythromycin Gel versus Its Vehicle. Acta Derm Venereol. 2002 82(4):260-265.

5. Perkins MA, Cardin CW, Osterheus MA, Robinson MK. A non-invasive method for recovery of inflammatory mediators to differentiate normal from compromised scalp conditions. Skin Res Technol. 2002 8(3):187-193.

6. Mills OH Jr., Cardin CW and Wortzman M. Assaying for bioavailability in acne. Book Chapter in Maibach. Cutaneous Biometrics. 2001.

7. Cardin CW. Isolated Dandruff. Book Chapter in Baran and Maibach. Cosmetic Dermatology 2nd edition. 2000.

8. Kullavanijaya P, Gritiyarandsan P, Bisalbutra P, Kulthanan C, Cardin C. Absence of Effects of Dimethicone- and Non-Dimethicone-Containing Shampoos on Daily Hair Loss. J. Soc. Cosmet. Chem, 45:195-206, 1992.

9. Cardin, C.W, Amon, R.B, Hanifin, JM and Hori Y. Nishinihon, The Antidandruff Efficacy of Head and Shoulders Rinse-in-Shampoo and Head and Shoulders Shampoo with Head and Shoulders Conditioning Rinse versus Merit Shampoo with Merit Conditioner. Nishinon J. Dermatol., 52:1208-1216, 1990 (In Japanese).

10. Cardin CW, Weaver JE, Bailey PT. Dose Response Assessments of Kathon Biocide: II. Threshold Prophetic Patch Testing. Contact Dermatitis 15:10-16, 1986.

11. Cardin CW, Domeyer BE, Bjorkquist L. Toxicological Evaluation of Commercial Alkyldimethylamine Oxides. Two Year Chronic Feeding and Dermal Studies. Journal of Fundamental and Applied Toxicology, 5: 869-878, 1985.

12. Weaver JE, Cardin CW, Maibach HI. Dose Response Assessment of Kathon Biocide: 1. Diagnostic Patch and Diagnostic Threshold Patch Testing with Sensitized Humans. Contact Dermatitis 12:141-145, 1985.

Presentations and Posters:

1. Kligman AM, Tagami H, Cardin CW, Berge CA, Smiles KA. Studies on differences in facial skin between Japanese and Caucasian women. Poster presented at the American Academy of Dermatology Meeting, San Francisco, March 2004.

2. Hickman JG, Cardin CW, Dawson TL, King B. Dandruff among teens – Prevalence & Fungal Speciation Characterization. Poster presented at the American Academy of Dermatology Meeting, San Francisco, March 2003.

3. Hickman JG, Wang X, King B, Cardin CW. Dandruff, Part I: Scalp Disease Prevalence in Caucasians, African Americans and Chinese and the Effects of Shampoo Frequency on Scalp Health. Poster #124 presented at the American Academy of Dermatology Meeting, New Orleans, March 2002.

4. Schwartz JR, Dawson TL, Kaczvinsky JR, Warren R, Cardin CW. Dandruff, Part III: Effective Treatment of Dandruff with Zinc Pyrithione (ZPT)- A Multi-Faceted Material. Poster #128 presented at the American Academy of Dermatology Meeting, New Orleans, March 2002.

5. Amon RA, Hickman JG, McCoy J, Toole J, Winters P, Cardin CW, Amburgey M, Chabi GH, Turner CB, Philippo JC, Rumping J, Cothran PE, Kalla KK, and Smiles KA. Comparison of the Antidandruff Efficacy of Several Zinc Pyrithione Shampoos Versus Antidandruff Shampoos Containing Ketoconazole, Coal Tar and Sulfur. Poster #303 presented at the American Academy of Dermatology Meeting, New Orleans, March 1999.

6. Cardin CW, Amon RA, Hickman JG, McCoy JC, Toole J, Winters P, Chabi G, Turner CB, Smiles KA. Comparison of Antidandruff shampoos containing Zinc Pyrithione, Ketoconazole, Coal Tar and Sulfur. Poster presented at the Intercontinental Hair Research Society Meeting, Washington D.C. November 1998.

7. Amon RA, Hickman JG, McMoy JC, Toole J, Cardin CW, Chabi GH, Phillippo JC, Kalla KK, Cothran PE, Smiles KA. The Anti-dandruff Efficacy of 1% Zinc Pyrithione Shampoos and Association with P. ovale Density. American Academy of Dermatology Meeting, Orlando, Florida, March 1998.

8. Mills, O Jr., Vowels BR, Leyden JJ, Berger RS, Cardin CW, Berge CA, Wille KK, Smiles KA. Bacterial Resistance and Therapeutic Outcome Following Three Months of Topical 2% Erythromycin (Em) Therapy Versus Its Vehicle Gel. Society for Investigative Dermatology, May 1998.

9. McCoy JC, Reed BR, Cardin CW, Chabi GH, Turner CB, Phillippo JC, Cothran PE, Smiles KA. Evaluation of the Sustained Antidandruff Efficacy of 1% Zinc Pyrithione Shampoo and the Delay in the return of Dandruff Flaking Following Therapy Cessation. American Academy of Dermatology Meeting, March 1998.

10. Mills O Jr., Berger RS, Turner CB, Wille KK, Cardin CW, Smiles KA. The Anti-Acne Efficacy of Salicylic Acid Cleansers. American Academy of Dermatology Meeting, March 1997.

11. Mills O Jr., Berger RS, Cardin CW. The Anti-Acne Efficacy of 2.5% versus 10% Benzoyl Peroxide Creams. American Academy of Dermatology meeting, March 1997.

12. Mills O Jr., Berger RS, Cardin CW, Turner CB, Erekuff G, Smiles KA. Analysis of Salicylic Acid Levels in the Sebaceous Follicle. Poster at the Society of Investigative Dermatology Meeting, May, 1995.

13. Mills O Jr., Berger RS, Cardin CW, Turner CB, Wille KK, Smiles KA. Assessment of the Anti-Acne Efficacy Potential of Salicylic Acid Formulations Using a Human Comedolytic Assay. Poster s at the American Academy of Dermatology Meeting in February, 1995 and the American Clinical Pharmacology Meeting in April, 1995.

Scientific Patents:

US Provisional Patent 60/867,630 11/29/2006 on Chemical Information Management System and Methods using the Same.

US Patent 5,292,304 issued 3/8/94 on Anti-lice Treatment Compositions.

US Patent 5,288,483 issued 2/22/94 on Anti-lice Treatment Compositions.

US Patent 5,104,645 issued 4/14/92 on Anti-dandruff Shampoos Compositions.

Educational Background:

1968-1972 B.Sc. Chemistry – Furman University, Greenville, South Carolina.

1972-1974 M.Sc. Biochemistry – University of South Carolina, Columbia, South Carolina.

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