Assistant Director, Clinical Scientist - Wyeth Pharmaceuticals

Location: Cambridge, MA
Categories: Administrative
Website: https://wyeth.recruitmax.com/main/careerportal/Job_Profile.cfm?szOrderID=21826&szReturnToSearch=1&szWordsToHighlight

Position Description

At Wyeth, we have a vision of leading the way to a healthier world. We’ve committed ourselves to achieving this vision by making quality, integrity and excellence the hallmarks of our business. A Fortune 500 company and global leader in pharmaceuticals, consumer healthcare, and animal healthcare products, we know that our employees are who keep us on the cutting edge of innovative discoveries and superior customer service. To sustain and enhance our leadership position in the pharmaceutical industry, we continue to recruit, develop and motivate individuals whose skills, values, and work ethic will grow and improve our business.

Assistant Director I – Clinical Scientist
Wyeth Pharmaceuticals
Cambridge, Massachusetts (Boston, MA)

JOB SUMMARY
The Clinical Scientist will provide study-level medical and scientific support in conjunction with the Global Medical Monitor. This includes assisting with protocol design and strategy, medical issue resolution, cross patient data review, creation of medical training and investigator meeting materials, decision point preparation, approval of patient narratives, review and approval of clinical data and audit response. The Clinical Scientist is accountable for protocol writing, ICF preparation, and patient-level data review and is involved with the ADD process, IDRP, CRF Design, site feasibility, CSR review, and design of the SAP and CDPP.

JOB RESPONSIBILITIES
- PROTOCOL AND STUDY DESIGN
Support the Global Medical Monitor (GMM) and/ or GCPL with specific tasks as delegated.
Protocol design & strategy.
Create medical training materials for Site Management.
Specific medical/ protocol training for RSMs and SMs.
Site medical/ protocol training for use during SIV.
Safety & protocol training at the investigator meeting.
Assist in preparation for consultants meetings.
Complete clinical section of the Site Reference Manual.
Participate in country feasibility as delegated by the GCPL and site feasibility and selection as delegated by the RMM (GMM in the country a study is managed from).
Independently write/design, protocol synopsis, and protocol amendments of moderate complexity in collaboration with the GMM, GTL, Statisticians, and other relevant groups.
Lead strategy discussions of moderate complexity and actively participates in consultant meetings.
Create informed consent template forms (ICF).
Review of site ICFs as drafted by RSMs.
- DATA REVIEW AND INTERPRETATION
Lead medical input for, and participant in, ADD/IDRP/CRF design.
Proactively coordinate with the GMM to assure understanding and buy-in on deliverables throughout the process.
Provide input for the design of Statistical Analysis Plan (SAP) and the Clinical Data Presentation Package (CDPP).
Responsible for review of patient level data across a study and coordinating with GMM for study level review as delegated.
Study analysis and decision point preparation.
Interpret data and be able to identify issues of moderate/difficult complexity.
Independently prepare efficient plan for medical review of data and moderate data independently.
- STUDY MEDICAL OVERSIGHT
Collaborate with the Global Trial Leader to provide medical guidance during the execution of the study.
Provide medical perspective in consultation with the GTL during development of the monitoring plan.
Answer specific Site Management protocol questions as needed (e.g. during SIV).
Medical issue resolution (study wide, escalated regional/ site).
Consulted during vendor selection for specific medical issues or questions.
Identify and independently resolve study related issues of moderate complexity; consult with supervisor GTL for study related issues of difficult complexity.
– SAFETY
Track and reconcile SAEs across a study.
Report SAEs during Safety Review Team meetings.
Ensure timely communication of safety issues to sites.
Review and approve patient narratives as delegated by the GMM.
JOB RESPONSIBILITIES CONTINUED
- REGULATORY AND PUBLICATIONS
Provide in-depth scientific/medical input, review and edit clinical study reports (CSR). Provide full review of content and integrate information from literature and other sources as appropriate.
Support and contribute to various sections of regulatory filings.
IB, IND/NDA Annual Reports, and PSURs.
Regulatory authority responses.
Participate with the GCPL and publications team to determine publication strategies.
Audit response as delegated by the GMM.
- GLOBAL MEDICAL AFFAIRS SPECIFIC TASKS
Support regulatory submissions on a global basis, both ad-hoc requests from agencies and planned periodic reports (PSUR, IND reports, NDA reports, Annual Product Assessment, ASUR, CTSUR for all marketed products in a TA).
Independent Management of IOP program: tracking, review/approval TA committee, contracting, budget, support of affiliate in same, payments and publication close out.
Lead preparation of Advisory Boards; supports them operationally with some input into content.
Provide guidance and assistance to affiliates worldwide in conduct of local Wyeth sponsored studies, local IOPs and other medical issues related to the TA.
Create and manage TA specific databases with 3rd party vendors.
Participate in design, management and running of non-clinical trial studies such as external database studies often with 3rd party vendors or external opinion leaders.
Data mining of current or legacy internal databases.
Aid GMA physician in Safety Review Team preparation or actions.
Participate in Life Cycle Strategy documents.
Interact with Opinion Leaders on non-study projects.
Support the publications review and approval process in the TA.

BASIC QUALIFICATIONS
* A Bachelors Degree, preferably with a science or health-related field. A Masters Degree, PhD or Pharm D, is preferred.
* Prior relevant clinical experience including protocol design: at least 7 years with a Bachelors; at least 5 with a Masters or at least 2 with a Doctorate.
* Direct experience with clinical trials and at least 1 year within industry/CRO.
* Scientific / medical knowledge to author and firmly understand protocols and other study documents prepared by Medical Research as well as demonstrated ability to integrate and summarize medical/scientific concepts in protocols and other documents.
* Working knowledge of statistics, data analysis and data interpretation.
* Exposure to drug development process with broad level of exposure in one of two areas.
* Strong understanding of basic physiological and pharmacological principles.
* Therapeutic knowledge of Oncology is preferred.
* AE/SAE expertise.
* Strong written and oral communication, organizational, and cross-functional collaboration skills.
* Proficiency with Microsoft Word, Excel, and Powerpoint.

How to Apply

If you are not viewing this from our career web site, go to https://wyeth.recruitmax.com/main/careerportal/login.cfm, click on the "Job Search" tab, use Keywords: "21826" for a search, click on the "Job Title" link and then "Apply To This Job" at the end of the page. If you are unsure whether or not you already have a candidate profile in our database, request your forgotten password before attempting to create a new one. Please make sure that you have both a text version of your resume in the appropriate field as well a Word version attached to your profile. Relocation assistance is available for this position. Wyeth offers competitive compensation and benefits programs, including child-care subsidies, flex-time, business casual attire, educational assistance and professional development programs. For more information please visit us at: www.wyeth.com/careers. Wyeth is an Equal Opportunity Employer, M/F/D/V.