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Clinical Program Leader

Novartis Pharmaceuticals Corporation

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Location:
Cambridge, MA
Posted Date:
7/22/2014
Position Type:
Full time
Job Code:
138778BR
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

To provide strategic medical guidance for, and to lead the development of, experimental immunomodulatory agents in the OTM portfolio. To provide expertise in immunology in the development of these agents in cancer. Leads projects introducing immunomodulatory agents in cancer, reports to clinical head and OTM LT Provides strategic medical guidance for the development of immunomodulatory agents in oncology from preclinical development and in early phase clinical development Provide clinical leadership and guidance to programs involving immunomodulatory agents in research The CPL is specifically responsible for creating a clinical development strategy that includes combinations across multiple diseases Work closely with Oncology Research, Oncology Translational Research, Clinical Pharmacology, and PCS to optimize clinical development plans The CPL is the leader for Early Program Teams (EPTs), beginning at the time of sPOC approval (approval to conduct GLP toxicology studies to enable the start of clinical development) and continuing through those clinical trials needed to demonstrated PoC. The CPL integrates preclinical information (pharmacology, toxicology, pharmacokinetics) and interprets its implications for clinical development, as articulated in the Investigator’s Brochure and first-in- human protocol. The CPL collaborates with clinical scientists to develop clinical protocols for OTM compounds and to develop the instruments needed to implement, interpret and report them (e.g., case report forms, report and analysis plans, clinical study reports). The CPL applies his or her medical knowledge to guide the safe, ethical and efficient conduct of the trials under his or her responsibility. He or she is knowledgeable in Good Clinical Practice guidelines and Novartis Standard Operating Procedures and strives to maintain compliance with them. The CPL liaises with outside experts, investigators, and regulatory and represents his or her projects to those groups and authorities. The CPL writes and reviews abstracts/manuscripts, etc. for presentation/publications at internal/external meetings. The CPL participates in task forces to support continuous improvement and other management objectives.
Novartis is an EEO employer M/F/D/V. This position will be filled at a level commensurate with experience.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. Our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
This position will be filled at a level commensurate with experience.
Local candidates strongly preferred
Minimum requirements  MD or DO degree required. Board-certification internal medicine or pediatrics with a strong background in immunology. Fluent English – Oral and written Needs a minimum of 3 pharma/biotech industry experience in the clinical development of immunomodulatory agents in oncology or the equivalent term experience in the academic setting. In case of no industry experience, substantially longer academic experience in with expertise in immunology and substantial clinical and/or clinical trial experience. Must have facility with the interpretation of preclinical data, (molecular biology, pharmacology, pharmacokinetics, and toxicology) Working knowledge of the application of PK/PD and biostatistics to clinical development and clinical trials Proven ability to analyze and interpret efficacy and safety data Excellent medical/scientific writing skills Effective written and oral communication skills Proven ability to manage and develop a team Excellent personal ethical integrity and a commitment to improving the outcomes for patients with malignancies.
Novartis is an EEO employer M/F/D/V. This position will be filled at a level commensurate with experience.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. Our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
This position will be filled at a level commensurate with experience.
Local candidates strongly preferred

Requirements

MD or DO degree required. Board-certification internal medicine or pediatrics with a strong background in immunology. Fluent English – Oral and written Needs a minimum of 3 pharma/biotech industry experience in the clinical development of immunomodulatory agents in oncology or the equivalent term experience in the academic setting. In case of no industry experience, substantially longer academic experience in with expertise in immunology and substantial clinical and/or clinical trial experience. Must have facility with the interpretation of preclinical data, (molecular biology, pharmacology, pharmacokinetics, and toxicology) Working knowledge of the application of PK/PD and biostatistics to clinical development and clinical trials Proven ability to analyze and interpret efficacy and safety data Excellent medical/scientific writing skills Effective written and oral communication skills Proven ability to manage and develop a team Excellent personal ethical integrity and a commitment to improving the outcomes for patients with malignancies.
Novartis is an EEO employer M/F/D/V. This position will be filled at a level commensurate with experience.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. Our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
This position will be filled at a level commensurate with experience.
Local candidates strongly preferred

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