Senior Director - Global Clinical Research - Pfizer - Madison

Job description
Org Marketing Statement
Pfizer Consumer Healthcare (PCH) is among the largest over-the-counter (OTC) health care products companies in the world, with a global footprint of operations in more than 90 countries. We maintain leadership positions in many markets and sell two of the top 10 global brands (Advil and Centrum). PCH develops, manufactures and markets leading non-prescription medicines, vitamins and nutritional products. We strive to bring new and better solutions to market that help consumers around the world support their health and enhance personal wellbeing.

PCH drives growth through major global brands including Centrum (the world's #1 multivitamin), Caltrate (the world's #1 calcium supplement) and Advil (the world's #1 ibuprofen analgesic brand). The division's major categories consist of Pain Management, Dietary Supplements, Respiratory and Personal Care.

Responsibilities
Pfizer Consumer Healthcare is looking for a Senior Director, Global Clinical Research to join our Global R&D team. This position is based full time in Madison, NJ.

JOB SUMMARY
The Senior Director of Clinical Research will be instrumental in supporting growth of the assigned Therapeutic Areas for which their team is assigned. The incumbent will have hands-on responsibility leading a clinical research team responsible for designing and executing clinical trials, and running programs focused on the development of Rx-to-OTC switch candidates and over-the-counter medications supporting NDA filings.

RESPONSIBILITIES
* Responsible for clinical development plan and trial design across all Phases of clinical research for multiple projects and therapeutic areas
* Serves as clinical expert for assigned clinical trials within the product team and is expected to provide input to decisions that may have clinical implications relative to his/her expertise.
* Effectively collaborates with Global Franchise teams members and within the Clinical Development organization to ensure study design and results are accurately communicated
*Design, author and review clinical protocols, case report forms and clinical sections of key regulatory submission documents and dossiers
*Draft clinical development plans, protocol profiles and participates in development of clinical and regulatory strategy for development candidates in collaboration with Regulatory Affairs
*Conduct medical review and interpretation of efficacy and safety data from clinical trials.
Prepares and participates in regulatory agency meetings and is point of contact for interactions with regulatory-agency clinical reviewing divisions on clinical matters
* Works with Clinical Research Scientists, Clinical Operations, CROs and trial sites to ensure expedient patient recruitment.
* Accurately interprets clinical study results and generate clinical study reports in collaboration with Biometrics
* * Participate in OTC industry association task force Initiatives
* Supports Standard Operating Procedures (SOPs), Good Clinical Practices, and all work processes to ensure the efficient & compliant clinical operation of studies conducted within PCH

Qualifications
EDUCATIONAL
* Advanced degree required (MD, PhD, or PharmD)
* Minimum of 7-10 years of clinical research experience in the pharmaceutical industry
* Previous management experience required
* Experience in non-prescription field preferable but not required

TECHNICAL SKILL REQUIREMENTS
* Knowledge of drug development (all phases of the clinical research process including protocol and case report form design, etc)
* Knowledge of GCP/ICH guidelines and FDA regulations
* Experience in NDA writing and compilation highly preferred
* Ad com experience highly preferred
* Capable of designing innovative clinical programs/clinical studies
* Ability to interpret clinical study results across multiple therapeutic areas
* Excellent verbal and written communication skills
* Superior decision making and problem solving
* Well-developed writing and editing skills that can be applied to a wide range of scientific documents
* Excellent interpersonal skills; detail oriented, with ability to work in a fast-paced environment
* Ability to effectively work in a cross-function matrix environment
* Proficient experience in MS Word, Excel, PowerPoint, and Outlook

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