Medical Director, Clinical Affairs - Newark, CA | Biospace
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Medical Director, Clinical Affairs

Depomed, Inc.

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Location:
Newark, CA
Posted Date:
2/25/2017
Position Type:
Full time
Job Code:
877XX
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

City Newark
State California [CA]
Title Medical Director, Clinical Affairs
Job ID 877XX
Date Added 2/6/2017
Department Clinical Affairs

Description

The Medical Director, Clinical Affairs is responsible for the medical oversight of Clinical Affairs programs and deliverables including the conduct of clinical trials in partnership with Clinical Operations and other functions. Additionally, forging productive partnerships with vendors and strategic alliance partners is essential. The Medical Director will report to the Vice President, Clinical Affairs.

ESSENTIAL JOB FUNCTIONS
•Support the generation of clinical development strategies
•Responsible for the creation of clinical development plans for both pipeline and approved products.
•Work closely with Clinical Operations to ensure the successful execution of sponsored Phase 1-4 clinical trials
•Participate in the design of sponsored clinical trials including the development of study protocols in close collaboration with the cross-functional study teams.
•Provide input to the selection of investigators
•Present at Investigators Meetings
•Provide medical oversight to and serve as medical monitor for sponsored clinical trials
•Provide medical review of clinical trial data
•Provide input to regulatory documents and submissions
•Support Clinical Affairs budget planning and management
•Maintain high level of expertise of the relevant disease areas and serve as medical resource for specific projects
•May support business development due diligence as needed

Requirements

The Medical Director, Clinical Affairs is responsible for the medical oversight of Clinical Affairs programs and deliverables including the conduct of clinical trials in partnership with Clinical Operations and other functions. Additionally, forging productive partnerships with vendors and strategic alliance partners is essential. The Medical Director will report to the Vice President, Clinical Affairs.

ESSENTIAL JOB FUNCTIONS
•Support the generation of clinical development strategies
•Responsible for the creation of clinical development plans for both pipeline and approved products.
•Work closely with Clinical Operations to ensure the successful execution of sponsored Phase 1-4 clinical trials
•Participate in the design of sponsored clinical trials including the development of study protocols in close collaboration with the cross-functional study teams.
•Provide input to the selection of investigators
•Present at Investigators Meetings
•Provide medical oversight to and serve as medical monitor for sponsored clinical trials
•Provide medical review of clinical trial data
•Provide input to regulatory documents and submissions
•Support Clinical Affairs budget planning and management
•Maintain high level of expertise of the relevant disease areas and serve as medical resource for specific projects
•May support business development due diligence as needed

About Us

Depomed, Inc. is a specialty pharmaceutical company focused on developing and commercializing products to treat pain and other central nervous system conditions. Founded in 1995, Depomed has successfully executed on strategy of acquiring, integrating and growing differentiated therapeutic products and building each into a strong market presence. The result is a broad portfolio of pain and neurology specialty pharmaceuticals currently comprised of five FDA-approved products. These include Gralise® for the management of Postherpetic Neuralgia (PHN), Cambia® for the acute treatment of migraine attacks, Zipsor® for the relief of mild to moderate acute pain, Lazanda® for the management of breakthrough pain in cancer patients and our most recent addition, the company’s flagship asset, the NUCYNTA® franchise.

Acquired in April 2015 and re-launched in June 2015, the NUCYNTA franchise includes NUCYNTA® ER for the extended management of pain, including neuropathic pain associated with diabetic peripheral neuropathy (DPN) and NUCYNTA® for immediate management of moderate to severe acute pain in adults.


Depomed also has successfully developed and licensed its unique drug-delivery technology, Acuform®. This patented oral-delivery technology allows for the targeted, extended release of pharmaceutical compounds into the upper gastrointestinal tract. The company’s Acuform technology is currently being used in four marketed drugs, including Gralise.

Depomed’s successful execution on strategy and has resulted in solid product revenue growth over the past three years. Located in Newark, California in the East Bay of San Francisco, Depomed is listed on the NASDAQ market under the ticker DEPO and employs approximately 500 people, of which approximately 350 are part of the Commercial organization.


Depomed is an AA/EEO/Veterans/Disabled employer.