Parnian Ph.D.
Global Regulatory Leader
VP, Regulatory Affairs & QA
Cambridge, Massachusetts
Section title
Parnian Ph.D.'s Email Addresses & Phone Numbers
About Parnian Ph.D.
GLOBAL REGULATORY AFFAIRS | PHARMACOKINETICS & CLINICAL PHARMACOLOGY Extensive experience across all stages of development (pre-IND through regulatory approval) and with various therapeutic areas including inflammation, oncology, and bone. Experienced in leading cross-functional regulatory and early development teams. Committed collaborator and leader with ability to achieve high quality results and to establish rapport and credibility with diverse...
GLOBAL REGULATORY AFFAIRS | PHARMACOKINETICS & CLINICAL PHARMACOLOGY Extensive experience across all stages of development (pre-IND through regulatory approval) and with various therapeutic areas including inflammation, oncology, and bone. Experienced in leading cross-functional regulatory and early development teams. Committed collaborator and leader with ability to achieve high quality results and to establish rapport and credibility with diverse team members. Areas of expertise: • Large and small molecule therapeutics • Experience with all drug development stages from discovery through marketing approval • Preparation of global regulatory strategic plans • Guiding teams regarding regulatory strategy and preparation for global regulatory interactions/submissions • Design of early clinical development plans • Design of & data interpretation for pharmacokinetic (PK) and pharmacodynamics (PD) non-clinical and clinical studies Available for consulting engagements. Please contact me at E: [email protected] Regulatory Leader @ As GRL led the cross-functional global regulatory team (GRT), co-led the product comparability team, and represented Global Regulatory Affairs on Product Strategy Team. From 2005 to 2014 (9 years) Early Development Team Leader/Associate Director II @ Led Product Strategy Team and its associated multi-disciplinary (clinical and nonclinical) development sub-team from entry into development through pre-IND FDA interactions for a protein therapeutic project in oncology. PKDM project lead on various programs and member of the PK leadership team. Supervised a team of scientists. From 2000 to 2005 (5 years) Senior Investigator @ Worked with both small molecules (idoxifene) and biologics in pre-IND through late stage development. Represented all aspects related to drug metabolism and pharmacokinetics on multi-disciplinary project teams. From 1996 to 2000 (4 years) Reviewer @ As a member of cross-functional review teams within Division of Cardiovascular and Renal Drug Products, reviewed and assessed an ANDA, several INDs, Clinical Pharmacology protocols and study reports. From 1995 to 1996 (1 year) University of California, San Francisco Parnian Ph.D. is skilled in: Regulatory Affairs, Drug Development, Clinical Development, Biotechnology, Oncology, Regulatory Submissions, Pharmacokinetics, IND, FDA, Drug Metabolism, Pharmacodynamics
Parnian Ph.D.’s Personal Email Address, Business Email, and Phone Number
are curated by ContactOut on this page.Parnian Ph.D.'s Work Experience
Amgen Inc
Global Regulatory Leader
2005 to 2014
Amgen Inc
Early Development Team Leader/Associate Director II
2000 to 2005
GlaxoSmithKline
Senior Investigator
1996 to 2000
Food and Drug Administration, Center for Drug Evaluation & Research
Reviewer
1995 to 1996
About Parnian Ph.D.'s Current Company
Amgen IncAs GRL led the cross-functional global regulatory team (GRT), co-led the product comparability team, and represented Global Regulatory Affairs on Product Strategy Team. As GRL led the cross-functional global regulatory team (GRT), co-led the product comparability team, and represented Global Regulatory Affairs on Product Strategy Team.
Frequently Asked Questions about Parnian Ph.D.
What company does Parnian Ph.D. work for?
Parnian Ph.D. works for Amgen Inc
What is Parnian Ph.D.'s role at Amgen Inc?
Parnian Ph.D. is Global Regulatory Leader
What is Parnian Ph.D.'s personal email address?
Parnian Ph.D.'s personal email addresses are not available
What is Parnian Ph.D.'s business email address?
Parnian Ph.D.'s business email address is p*****@amgen.com
What is Parnian Ph.D.'s Phone Number?
Parnian Ph.D.'s phone +44 ** **** *192
What industry does Parnian Ph.D. work in?
Parnian Ph.D. works in the Biotechnology industry.
Who are Parnian Ph.D.'s colleagues?
Parnian Ph.D.'s colleagues are Melanie Call, Steve Shamah, Karen Tran, Michelle Ols, Erin Boyer, Tariq Kassum, Celeste Richardson, Henry Rogalin, and Catherine Stehman-Breen
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