Clinical Scientist Specialist MetMAB
Location: San Francisco California
Description: Roche is looking of Clinical Scientist Specialist MetMAB right now, this vacancy will be placed in California. Detailed specification about this vacancy opportunity kindly read the description below. Provides clinical oversight for a variety of projects, in consultation with his/her Medical Director or Senior Medical Director :
- Works with a host of internal and ! external partners and stakeholders in the implementation of clinical trials for assigned drugs/indication
- Provides scientific input into and/or coordinates the development of specific clinical trial documents for review and discussion with Medical Directors* (e.g., protocols, charters, safety monitoring plans, process documents, etc.) including disease and/or treatment registries
- Participates in the identification of appropriate external investigators
- Oversees the clinical trial implementation, ongoing monitoring and evaluation, working closely and regularly with external investigators and Clinical Operations. Active Member in Study Management Team for assigned drugs/indications
- Develops and cultivates relationships with external partners such as clinical investigators, clinicians, scientists and KOLs, as well as cross-functional partners in Clinical Development, Commercial, Legal and Regulatory.
- Supports his/her manager in devel! oping clinical components of presentations* for clinical trial! investigator meetings
- In collaboration with his/her manager, coordinates the preparation and reviews data outputs for reporting documents* where appropriate (e.g. clinical study reports, analysis plans, etc.) with the CRO, the Medical Affairs Biostatisticians and his/her Medical Directors
- Monitors project progress and is expected to proactively identify any issues or challenges and recommend and implement strategies to effectively resolve such once approved with his/her manager
- Works closely with his/her manager, the publication team and Clinical Operations to complete associated publications, reviews draft publications*.
- Keeps all partners abreast of projects progress throughout all applicable intervals
- May also participate/coordinate collaborations with external stakeholders
approved clinical projects.
- May coordina! te, liaise with internal and external providers for data mining activities
- Helps his/her manager provide data outputs requested for safety and/or other relevant sections of IND annual reports, if these sections and reports relate to assigned drugs and/or indications*.
- May interact with NCI or other agency, as appropriate, with supervision from his/her manager
- Stays abreast of internal and external developments (scientific, clinical, commercial, competitive, legal, regulatory and like) as such developments may implicate or otherwise impact the implementation of the medical plan of the assigned drug(s)/indication(s). Includes attendance at major scientific conferences, participation in competitive intelligence activities, and review of published literature Who you are
Where a job title is not considered the final definition ! of who you are, but the starting point.
Strong scientific Academic background, PhD or PharmD preferred, Advanced nursing degree with some additional post graduate training will be considered.
- Must demonstrate 2 or more years’ clinical trial experience relevant to biotech/pharmaceutical molecules or drugs Experience working with the principles and techniques of data analysis, interpretation and clinical relevance
- Strong, relevant experience in the therapeutic area (as typically measured by 5 or more
- Must demonstrate understanding of late-stage drug development, in particular Phase IV
- Must demonstrate understanding of product and safety profiles
- Versed in medical aspects of FDA regulations with regards to conduct of clinical trials
- Business travel is required
- Outstanding attention-to-detail
- Demo! nstrable abilities to work more independently (with limited guidance and supervision) in implementing and overseeing clinical plans, trials and other programs
- Excellent project management skills: can prioritize multiple tasks and goals to ensure the
- Sound business acumen; has knowledge of the multi-disciplinary functions involved in a company’s drug development process, e.g., clinical operations, biostatistics, regulatory, commercial, etc. and can proactively integrate the relevant functions into projects for best end-results
- Strong interpersonal and influencing skills: has established strong relationships with key internal partners and stakeholders, as well as thought leaders, cooperative groups and disease organizations.
- Sound communica! tion and business presentation skills: communicates in a timely, thorou! gh and concise manner and is comfortable presenting information to others at varying organizational levels
- Good negotiation skills: knows how to complete deliverables by working effectively with others internally and externally
- Proven track record of effective decision-making: makes good business decisions and exercises sound judgment. Consistently and effectively balances decisions with imperatives for ethics and efficacy
- Demonstrates behaviors and values consistent with Genentech’s Good Operating Principles *LI-EK1
Roche is an Equal Opportunity Employer
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If you were eligible to this vacancy, please email us your resume, with salary requirements and a resume to Roche.
If you interested on this vacancy just click on the Apply button, you will be redirected to the official website
This vacancy starts available on: Tue, 30 Apr 2013 23:17:14 GMT