Director/Associate Director Translational Medicine - South San Francisco , CA | Biospace
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Director/Associate Director Translational Medicine

Puma Biotechnology

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Location:
South San Francisco , CA
Posted Date:
9/5/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Summary/Objective

The Associate Director/Director, Clinical Science, acts as an independent Translational and Clinical Scientist responsible for one or multiple drug projects. This person interacts with all members of the clinical development team as well as regulatory authorities and key opinion leaders, may supervises other Translational/Clinical Scientists providing support to the projects and is accountable for quality of Translational Medicine input and deliverables. Responsibilities may include some or all of the following:


Essential Functions
•   Function as Clinical Scientist on PUMA sponsored studies
•   Lead regularly scheduled Data Review Committee
•   Responsible for data cleaning
•   Write and review Clinical Study Reports, and clinical components of modules for the NDA, MAA and other regulatory submissions.
•   Contribute to additional clinical and pre-clinical projects as assigned
•   Effectively manage projects as part of a multidisciplinary team
•   Review, interpret, and present clinical data from development programs and the relevant literature at relevant governance and regulatory meetings, scientific congresses and advisory committees
•   Contribute to publications and presentations.
•   Represent supported projects at scientific conferences and advisory committees
•   Leads interactions with investigators and cooperative groups
•   Other duties as assigned



Competencies

Must be fully knowledgeable and skilled in the development and implementation of:
•   A clinical plan
•   Protocol design and writing
•   Study team management
•   Data review and interpretation
•   CSR
•   Oversee the clinical management of 1 -3 drug products and programs
•   Must be skilled in functional and cross-functional people and project management
•   Must be fully knowledgeable and skilled in the development and writing of regulatory documents including:
o   IND
o   NDA/sNDA
o   IB


Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that ae required of the employee for this job.  Duties, responsibilities and activities may change at any time with or without notice.


Supervisor Responsibilities
This position may manage employees of the department and is responsible for the performance management and hiring of any employees reporting to this role within that department.


Position Type/Expected Hours of Work

This is a full-time position. Days and hours of work are Monday through Friday, 8:30 a.m. to 5 p.m. This position regularly requires long hours and may require weekend work.

Work Environment
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Physical Demands
The physical demands described are representative of those that must be met by an employee to successfully perform the primary functions of this position.

The physical demands of the office are normally associated with extended amounts of time sitting and using office equipment, including a computer, keyboard and mouse, which can cause muscle strain. While performing duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel objects, tools or controls; reach with hands and arms; climb stairs; balance; stoop, kneel, crouch or crawl; and talk or hear. The employee must occasionally lift or move up to 25 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus.

Travel
Travel is primarily local during the business day, although some out-of-area and overnight travel may be expected. Travel may be required (up to 10 %).


Equal Opportunity Employer

Puma Biotechnology Inc is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, ethnicity, age, disability, veteran status, marital status, or any other characteristic protected by law


Requirements

Required Education & Experience
•   Advanced Clinical/Science Degree (e.g. PharmD, PhD, MSN, MPH)
•   Demonstrated experience in pre-clinical drug discovery
•   Minimum of 5 years clinical development experience in the pharmaceutical or biotechnology industry
•   Knowledge of international regulations pertinent to current clinical development (eg ICH, FDA, EMA)

Additional Eligibility Qualifications
•   Highly advanced oral, writing and presentations skills
•   Communicates internally with senior management
•   Communicates externally with scientific congresses and advisory boards
Management of Staff
•   Up to 2 direct reports including an administrative team member