Biotech Jobs information:- Medical Director, Clinical Research

Sr. Medical Director, Clinical Research - Pulmonary
Clinical direction of interdisciplinary drug development team responsible for the design, implementation, and completion of a clinical research program for drug(s) or biologic(s), leading to the submission and successful approval of a New Drug Application (NDA) to the FDA. Major Responsibilities will include:

• Strategic Planning of Drug Development
• Design and Conduct of Clinical Trials, in particular clinical trials to advance the development of assests encompassing the respiratory and critical care arena.
• Knowledge and personal relationship with thought leaders in the respriratory and allergy fields, and ability to leverage contacts for the formation of advisory boards.
• Preparation and review of written documents: Clinical Trial Protocols, Case Report Form, Clinical Study Reports
• Interactions with key individuals from other disciplines on the drug development project team
• Preparation of documents for submission to regulatory authorities (Meeting Packages, Investigational Drug Applications [IND], NDAs, clinical components of other regulatory correspondence)
• Participation as clinical expert in the evaluation of early discovery compounds or early stage external assets for their potential to be successfully candidates for pharmacologic development

ESSENTIAL FUNCTIONS REQUIRED FOR JOB
• Ongoing thorough and up-to-date knowledge of therapeutic areas of assets for development, including trends, advances, understanding of mechanism of acting and efficacy of therapies currently available, and competitive clinical landscape
• Close collaboration with Drug Safety, Regulatory, New Products Planning and Discovery and other disciplines within Sepracor.
• Interaction with Medical Affairs and Commercial group to achieve optimal target product profile for drugs in development and to achieve optimal commercialization of approved drugs.Experience required10+ YearsExperience and other requirementsKNOWLEDGE, SKILLS AND ABILITIES REQUIRED

Education:
MD or DO from an accredited Medical School
US Board Certification in Internal Medicine or Pediatrics
Subspecialty Training and Board Certification in Medical Subspecialty Pulmonary, Critical Care, and Allergy/Immunology highly preferred.

Experience

10+ years of clinical trial experience, of which at least 3 years should be within the pharmaceutical industry. Background in clinical research including, ideally to include previous positions both in academic medicine and in pharmaceutical research, ideally in the development of drug or biological therapies. The successful candidate should have a track record of publications in peer-reviewed medical journals and national/international recognition as a clinical researcher in respiratory disease. Additional scientific training, such as a Ph.D. degree is desirable. Knowledge of FDA-CDER regulations regarding evaluation and approval of pharmaceuticals is necessary, as is an understanding of US pharmaceutical safety reporting and surveillance.

Complexity

Personal Contacts
Excellent interpersonal and communication skills with the ability to balance multiple tasks and work within a multi-disciplinary team. The position requires effective, fact-based interaction with scientists from various internal and external sites.
Confidential Data
All information (written, verbal, electronic, etc.) that an employee encounters while working at Sepracor is considered confidential.

Mental/Physical Requirements
Fast paced office environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.

Additional Requirements
Hours may include meetings scheduled outside of normal working hours. Demands during peak times may require work hours outside of normal working hours. Some travel will be required, estimated to be 10-20% of time. This will include presentation of clinical research data at national and international conferences, advisor boards and interaction with key opinion leaders in the therapeutic area, and diligence evaluations of potential in-licensing and/or partnering candidates.

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Go To HOME Go To Biotech Main Page	Sr. Medical Director, Clinical Research - Pulmonary Clinical direction of interdisciplinary drug development team responsible for the design, implementation, and completion of a clinical research program for drug(s) or biologic(s), leading to the submission and successful approval of a New Drug Application (NDA) to the FDA. Major Responsibilities will include: • Strategic Planning of Drug Development • Design and Conduct of Clinical Trials, in particular clinical trials to advance the development of assests encompassing the respiratory and critical care arena. • Knowledge and personal relationship with thought leaders in the respriratory and allergy fields, and ability to leverage contacts for the formation of advisory boards. • Preparation and review of written documents: Clinical Trial Protocols, Case Report Form, Clinical Study Reports • Interactions with key individuals from other disciplines on the drug development project team • Preparation of documents for submission to regulatory authorities (Meeting Packages, Investigational Drug Applications [IND], NDAs, clinical components of other regulatory correspondence) • Participation as clinical expert in the evaluation of early discovery compounds or early stage external assets for their potential to be successfully candidates for pharmacologic development ESSENTIAL FUNCTIONS REQUIRED FOR JOB • Ongoing thorough and up-to-date knowledge of therapeutic areas of assets for development, including trends, advances, understanding of mechanism of acting and efficacy of therapies currently available, and competitive clinical landscape • Close collaboration with Drug Safety, Regulatory, New Products Planning and Discovery and other disciplines within Sepracor. • Interaction with Medical Affairs and Commercial group to achieve optimal target product profile for drugs in development and to achieve optimal commercialization of approved drugs.Experience required10+ YearsExperience and other requirementsKNOWLEDGE, SKILLS AND ABILITIES REQUIRED Education: MD or DO from an accredited Medical School US Board Certification in Internal Medicine or Pediatrics Subspecialty Training and Board Certification in Medical Subspecialty Pulmonary, Critical Care, and Allergy/Immunology highly preferred. Experience 10+ years of clinical trial experience, of which at least 3 years should be within the pharmaceutical industry. Background in clinical research including, ideally to include previous positions both in academic medicine and in pharmaceutical research, ideally in the development of drug or biological therapies. The successful candidate should have a track record of publications in peer-reviewed medical journals and national/international recognition as a clinical researcher in respiratory disease. Additional scientific training, such as a Ph.D. degree is desirable. Knowledge of FDA-CDER regulations regarding evaluation and approval of pharmaceuticals is necessary, as is an understanding of US pharmaceutical safety reporting and surveillance. Complexity Personal Contacts Excellent interpersonal and communication skills with the ability to balance multiple tasks and work within a multi-disciplinary team. The position requires effective, fact-based interaction with scientists from various internal and external sites. Confidential Data All information (written, verbal, electronic, etc.) that an employee encounters while working at Sepracor is considered confidential. Mental/Physical Requirements Fast paced office environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. Additional Requirements Hours may include meetings scheduled outside of normal working hours. Demands during peak times may require work hours outside of normal working hours. Some travel will be required, estimated to be 10-20% of time. This will include presentation of clinical research data at national and international conferences, advisor boards and interaction with key opinion leaders in the therapeutic area, and diligence evaluations of potential in-licensing and/or partnering candidates. Click Here & Go to The website For Applying Job