CenterWatch

1+ months

VP of Clinical Development - San Diego, CA

Kelly Services
San Diego, CA 92108
**VP of Clinical Development San Diego, CA**



The VP of Clinical Development will report to the CEO and serve as Clinical Medical Lead, providing strategic direction and technical leadership to the clinical development group including: clinical trial design, implementation and execution, data analysis and management. This role will provide medical and scientific expertise in collaboration with cross-functional teams to ensure successful execution of clinical activities, data analysis, and interpretation and oversight of CROs. Working closely with the leadership team, clinical lead will develop and execute regulatory and Phase I-II clinical trial strategy and design.



**Essential Duties and Responsibilities:**




+ Responsible for working with CROs to complete clinical portions of regulatory filings, including protocols and protocol amendments, investigator brochures, drug safety update reports, clinical study reports, medical reports, efficacy and safety summaries, and benefit/risk ratios.

+ Participate in study team meetings, Data Monitoring Committee (DMC) and steering committees as required.

+ Develop and maintain key opinion leader relationships and serve as the medical lead for advisory meetings.

+ Establish and maintain relationships with alliance partners, external companies especially CROs, investigators and opinion leaders to optimize performance on clinical trial activities.

+ Accountable for clinical portion of regulatory documents such as Investigator Brochure update, and Drug Safety Update Reports.

+ Manage and be responsible for pharmacovigilance for clinical projects including review and reporting of SAEs with support from pharmacovigilance providers as available.

+ Work collaboratively with Research providing clinical input into new target selection and preclinical studies.

+ Participate in business development processes as needed.



**Job Requirements:**




+ MD required with a minimum 10 years industry experience in drug development in biotech or pharmaceutical company.

+ 4 years of experience in people management including direct reports preferred.

+ Extensive experience in clinical trial protocol development, conduct, data analysis, regulatory submissions and regulatory authority interactions.

+ Strong knowledge and respect of ICH /FDA / EMA regulations and guidelines, and applicable international regulatory requirements.

+ Experience with RNA-based drugs (siRNA, mRNA) is highly valued.

+ Extensive experience working in multifunctional and multinational teams.

+ Demonstrated experience of FDA/EMEA/Japan PMDA requirements, good clinical practices and pharmaceutical clinical development in oncology and or fibrosis.

+ Clinical practice and/or industry experience in Oncology or Fibrosis is highly valued.

+ Demonstrated ability to think strategically and successfully operationalize ideas and visions.

+ Excellent communications skills; team member that can work collaboratively and extremely well with colleagues across all functions and levels.

+ Demonstrated track record as a solid, thoughtful leader with exceptional interpersonal skills.

+ Excellent analytical and strategic planning skills, with a track record of recruiting and/or out-sourcing high-performing clinical teams.

+ Proven organizational skills and ability to handle multiple diverse projects simultaneously.



**Apply Today! Questions? Call Elijah at 602.548.1774 or email at Elijah.Bruder@kellyscientific.com**






**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.

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Posted: 2018-12-17 Expires: 2019-01-21

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VP of Clinical Development - San Diego, CA

Kelly Services
San Diego, CA 92108

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