CenterWatch

1+ months

Sr/Director Clinical Research

Kelly Services
San Francisco, CA 94103
**Kelly Scientific Resources** is a specialty service of Kelly Services. As the world's largest provider of HR solutions to the scientific community, Kelly Scientific Resources is focused exclusively on placing skilled scientific professionals in contract, contract-to-hire, and full-time science jobs across a full spectrum of related industries and disciplines. Our scientists contribute to the research and development of therapeutics that change the lives of those affected with disease. We have an exciting direct hire opportunity in the San Francisco Area for a Director and Sr Directior Clinical Research to join a leading biotherapeutics client.





**DIRECTOR and SR DIRECTOR, CLINICAL RESEARCH INFECTIOUS DISEASE (2 positions)**



**JOB SUMMARY:**



San Francisco based company focused on infectious disease, seeks a Sr Director and Director of Clinical Research, Infectious Disease. Reporting to the VP for Clinical Development, this is a crucial position. You will play a key role at all stages of development, focusing initially on late stage development for all infectious disease programs from the drug discovery stage through product registrations world-wide.



**RESPONSIBILITIES:**




+ Will work collaboratively with the clinical team on all scientific aspects of conceptualizing and planning trials.

+ Responsible for various aspects and oversight for ongoing and planned clinical trials including but not limited to abstract submission, investigator meetings and Scientific Advisory Boards.

+ May serve as a resource to other functions in evaluating business development opportunities.

+ Will work with a senior member of the clinical development team to provide high level input to complex Phase I-IV clinical trial protocol design and clinical study reports as well as Health Authority inquiries.

+ Will work collaboratively with the clinical development team to provide ongoing clinical monitoring for clinical trials including, but not limited to, assessment of eligibility criteria, toxicity management and drug safety surveillance.

+ Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as SOPs.

+ Will work collaboratively with the clinical development ton the clinical research components in the preparation/review of regulatory documents, IND annual reports, IND safety reports, Investigator Brochures and development plans.

+ Coordinates the collection and assimilation of ongoing data for internal analysis and review.

+ Coordinates and manages the preparation and/or review of data listings, summary tables, study results and scientific presentations.

+ Helps to prepare scientific information for presentation at scientific conferences as well as clinical study investigator meetings.

+ Analyze and summarize data for presentation to senior management and regulatory agencies.

+ Provide assistance and support in managing relationships with regulatory affairs, biostatistics, and other non-clinical departments. Provide strategic guidance on non-regulatory clinical trial plans.



**QUALIFICATIONS AND EXPERIENCE:**




+ 4+ years of relevant experience in Pharmaceutical industry for Director level, 5+ years for Sr Director level and preferably with ID specialization or relevant work.

+ The successful candidate will have the knowledge, experience, and skills typically developed by a strong track record of accomplishment in the field of clinical research. BLA or NDA experience will be highly valued.

+ Excellent scientific written and oral communication skills as well as interpersonal skills are required. Must possess a proven ability to work highly effectively with multiple departments.

+ Must be capable of working with attention to detail in a time sensitive environment.

+ Strong familiarity with good clinical practices and International Conference on Harmonization Guidelines is preferred.

+ The candidate we seek is expected to maintain a professional relationship with therapeutic area opinion leaders worldwide, and is equally comfortable discussing the science and research approaches that are critical for study protocol design, clinical endpoints and data interpretation.




+ Innate flexibility to work in a rapidly growing matrixed environment. Strong leadership skills with an ability to set a vision, lead change, and mentor others.

+ Strategic thinker with ability to formulate, develop and execute clinical strategies.

+ Excellent interpersonal skills with ability to lead, interact with, focus, resolve conflict and drive consensus among individuals from a variety of cultures and disciplines.



**EDUCATION:**




+ MD preferred, however PharmD with extensive late phase experience will be considered.








**Why Kelly** **** **?**



With Kelly, youll have access to some of the worlds highest-regarded scientific organizations
providing you with opportunities to work on todays most challenging, research-intensive, and relevant
projects. Our connections can lead you to innovative scientific pursuits youll be proud to help
advance. We work with 95 of the Fortune 100 companies, and found opportunities for more than 9,000
scientific professionals last year.


You pursued a career in science to fuel your quest for knowledge and your desire to make the world
a better place. Let Kelly fuel your careerconnect with us today.




**AboutKelly Services** ****



As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect
with us on Facebook , LinkedIn and Twitter .


Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.

Categories

Posted: 2019-02-25 Expires: 2019-04-27

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Sr/Director Clinical Research

Kelly Services
San Francisco, CA 94103

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