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Director Of Clinical Operations Jobs

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Job Title: Senior Director Clinical Research- Respiratory Inflammation TA
Company: AstraZeneca
Location: Wilmington, DE

Description:
Graduate of a recognized school of medicine with an M.D. degree or equivalent.- Specialty training and board certification or eligibility in Pulmonology or Allergy.- Familiarity with biostatistics. Demonstrated clinical research experience in an academia or industry.- Excellent written and oral communication, interpersonal, and organizational skills.- Ability to travel nationally and internationally.Preferred Background: Board eligibility/certification in Pulmonology or Allergy.- Background in clinical or basic science/translational research required. Five years or more experience in drug development/medical affairs required. Experience working with regulatory authorities, preparing regulatory documents, and preparation of promotional materials required. A thorough understanding of US pharmaceutical safety reporting and surveillance required. Experience supervising physicians and/or scientific staff in a management or team leader capacity highly desirable. Individuals with less experience may be considered for a Director level role.Leadership Capabilities:* Passion for Customers* Thinks Strategically* Acts Decisively* Drives Performance* Works Collaboratively* Develops People & OrganizationAstraZeneca




Job Title: Director Clinical Research - Respiratory Inflammation TA
Company: AstraZeneca
Location: Wilmington, DE

Description:
Leadership Capabilities:* Passion for Customers* Thinks Strategically* Acts Decisively* Drives PerformanceGraduate of a recognized school of medicine with an M.D. degree or equivalent.- Specialty training and board certification or eligibility in Pulmonology or Allergy.- Familiarity with biostatistics. Demonstrated clinical research experience in an academia or industry.- Excellent written and oral communication, interpersonal, and organizational skills.- Ability to travel nationally and internationally.Preferred Background: Board eligibility/certification in Pulmonology or Allergy.- Background in clinical or basic science/translational research desirable. Two to three years experience in drug development/medical affairs (required for Director). Knowledge of CDER regulations regarding evaluation and approval of pharmaceuticals (regulatory interaction experience required for Director). An understanding of US pharmaceutical safety reporting and surveillance (required for Director).Individuals with less experience may be considered for an Associate Director level role.Leadership Capabilities:* Works Collaboratively* Develops People & OrganizationAstraZeneca




Job Title: Director of Clinical Research
Company: OPKO Health, Inc.
Location: Miami, FL

Description:
OPKO Health, Inc. is a publicly traded healthcare company involved in the discovery, development, and commercialization of proprietary pharmaceutical products, medical devices, vaccines, diagnostic technologies and imaging systems. We offer competitive compensation and an excellent benefit package. Summary: - Plans and directs the clinical research activities involving new drug entities, including clinical drug development strategy, clinical trial design and execution, and regulatory reporting. - Formulates clinical development strategies for investigational drugs - Participates in internal or external research teams relevant to the development of new compounds - Evaluates pre-clinical and transitional work for the purpose of generating clinical development plans - Leads and supports the planning, execution and reporting of Global Clinical Trials - Monitor and manage the conduct of ongoing and new clinical trials - Analyzes and summarizes clinical findings from studies to support the decisions regarding safety and efficacy as well as new drug applications, clinical study reports or publications - Responsible for FDA and other Agency interactions for clinical research, including regulatory reporting and agency discussions around plans and results - Author and review clinical study reports Requirements: - MD, or MD/PhD who is board certified or eligible for certification. - 5-7 years experience in the clinical development/research of late stage investigational drug candidates combined with a demonstrated track-record of accomplishments. - Strong scientific knowledge and awareness of scientific developments in areas of expertise - Experience and proven track record of accomplishments in clinical medicine and biomedical research - Experience in selecting and managing vendors and implementing clinical drug trials - Ability to take initiative, to maintain confidentiality, to meet deadlines, and to work in a team environment essential. Please e-mail your resume/cv to Register to View




Job Title: Associate Director Clinical Research - Clinical Pharmacology
Company: Merck
Location: Rahway, NJ

Description:
Associate Director Clinical Research - Clinical Pharmacology:CLI002139 Description Merck is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well as animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork.As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. Responsible for the development and execution of the Clinical Pharmacology strategy for a given program from preclinical candidate approval through the worldwide marketing application. Keymember of the early development team, providing a leadership role on the team with regard to design and execution of early clinical development strategy. Responsible for Clinical Pharmacology activities for a given program Authors initial program clinical plans, the early development plan, Clinical Pharmacology Phase I studies through Phase Ib Responsible for timely and safe execution of CP program studies. Ensure appropriate technical transfer of experimental medicine qualified platforms. Interact closely with internal and external clinical study support staff and scientists(includingdiscovery research, biostatistics, drug metabolism, regulatory affairs, and global clinical trials operations). Provide Clinical Pharmacology support for programs through the worldwide marketing application filing including supportive registration documents and presentations. Responsible for clear, timely communication and interpretation of Clinical Pharmacology results Franchise, Function, and governance committees. Qualifications M.D or M.D./Ph.D, plus Board Certification or Eligibility is preferred. Demonstrated record of scientific scholarship and achievement. A proven track record in clinical medicine and background in biomedical research is essential. Prior specific experience in clinical research and prior publication is desirable but not necessary. Strong interpersonal skills, as well as the ability to function in a team environment are essential. Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Merck's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. To be considered for this position, please visit our career site at to create a profile and submit your resume forrequisition # CLI002139. Merck is an equal opportunity employer, M/F/D/V - proudly embracing diversity in all of its manifestations. Search Firm Representatives Please Read Carefully: Merck is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via-email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means. Primary Location:US-NJ-Rahway Other Locations: Employee Status:Regular Travel: Number of Openings:1 Shift (if applicable): Company Summary View Details




Job Title: Associate Director Clinical Research - Clinical
Company: Merck
Location: Rahway, NJ

Description:
Associate Director Clinical Research - Clinical Pharmacology Job Associate Director Clinical Research - Clinical Pharmacology-CLI002139DescriptionMerck is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well as animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.Responsible for the development and execution of the Clinical Pharmacology strategy for a given program from preclinical candidate approval through the worldwide marketing application.Key member of the early development team, providing a leadership role on the team with regard to design and execution of early clinical development strategy.Responsible for Clinical Pharmacology activities for a given programAuthors initial program clinical plans, the early development plan, Clinical Pharmacology Phase I studies through Phase IbResponsible for timely and safe execution of CP program studies.Ensure appropriate technical transfer of experimental medicine qualified platforms.Interact closely with internal and external clinical study support staff and scientists (including discovery research, biostatistics, drug metabolism, regulatory affairs, and global clinical trials operations).Provide Clinical Pharmacology support for programs through the worldwide marketing application filing including supportive registration documents and presentations.Responsible for clear, timely communication and interpretation of Clinical Pharmacology results Franchise, Function, and governance committees.QualificationsM.D or M.D./Ph.D, plus Board Certification or Eligibility is preferred.Demonstrated record of scientific scholarship and achievement.A proven track record in clinical medicine and background in biomedical research is essential.Prior specific experience in clinical research and prior publication is desirable but not necessary.Strong interpersonal skills, as well as the ability to function in a team environment are essential.Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Merck's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.merck.com/careers to create a profile and your resume for requisition # CLI002139. Merck is an equal opportunity employer, M/F/D/V - proudly embracing diversity in all of its manifestations. Search Firm RepresentativesPlease Read Carefully:Merck is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via-email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.Primary Location:US-NJ-RahwayEmployee Status:RegularNumber of Openings:1




Job Title: Scientific Research Director
Company: Memorial Sloan-Kettering Cancer Center
Location: New York, NY

Description:
Scientific Research DirectorComputational & Systems BiologyComputational Biology CenterMemorial Sloan-Kettering Cancer Center in New York CityJoin the interdisciplinary Computational Biology Center (www.cbio.mskcc.org) at Memorial Sloan-Kettering Cancer Center (MSKCC) in New York City in an important leadership position. Assisting the Head of the Computational Biology Center (cBio), you will coordinate the scientific operations of cBio and help develop and present the centers scientific projects and mission. Your managerial role, working with administrative assistants and faculty, includes recruitment, budget planning, reports, public communications, space and resource allocation, as well as grant applications. Your scientific role includes the conceptual and organizational development of scientific collaborations, as well as planning of the scientific content of conferences, seminar series, workshops and retreats. cBio plans to have seven (currently four) research groups in computational and systems biology in 2012 and has a support group, the Bioinformatics Core. cBio has also taken the lead on 3 large-scale NCI-funded research initiatives at MSKCC: a Genome Data Analysis Center of The Genome Cancer Atlas (GDAC-TCGA), a Physical Sciences Oncology Center (PS-OC) and a Center for Cancer Systems Biology (CCSB). Communication, networking and coordination will be important: within the Center; across all of MSKCC, bridging clinical and biological research programs, and including key administrative departments; across the three institutions of the tri-institutional program; and, to the broader scientific community.We imagine: You are excited by institution building and take satisfaction from facilitating the scientific success of an interdisciplinary team. You have broad scientific knowledge, e.g., in computational biology, systems biology, genomics or cancer research, as well as strong administrative and managerial skills. You have a Ph.D. or equivalent and at least 3 years of experience in a leadership position, and management experience at an academic institution, biotech or pharmaceutical company, or scientific publishing house.Computational Biology research at MSKCC aims to: Analyze and simulate biological processes at different levels of organization Predict the results of interventions in biological systems Improve the prevention, diagnosis, prognosis and therapy of cancer Innovate in biological researchClose collaboration with experimental and clinical groups using high-throughput and functional genomics data is a major cornerstone of cBio.




Job Title: Associate Director Clinical Research - Clinical Pharmacology-CLI002139
Company: Merck & Co. Inc.
Location: Rahway, NJ

Description:
Associate Director Clinical Research - Clinical Pharmacology-CLI002139 Description Merck is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well as animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. Responsible for the development and execution of the Clinical Pharmacology strategy for a given program from preclinical candidate approval through the worldwide marketing application. Key member of the early development team, providing a leadership role on the team with regard to design and execution of early clinical development strategy. Responsible for Clinical Pharmacology activities for a given program Authors initial program clinical plans, the early development plan, Clinical Pharmacology Phase I studies through Phase Ib Responsible for timely and safe execution of CP program studies. Ensure appropriate technical transfer of experimental medicine qualified platforms. Interact closely with internal and external clinical study support staff and scientists (including discovery research, biostatistics, drug metabolism, regulatory affairs, and global clinical trials operations). Provide Clinical Pharmacology support for programs through the worldwide marketing application filing including supportive registration documents and presentations. Responsible for clear, timely communication and interpretation of Clinical Pharmacology results Franchise, Function, and governance committees. Qualifications M.D or M.D./Ph.D, plus Board Certification or Eligibility is preferred. Demonstrated record of scientific scholarship and achievement. A proven track record in clinical medicine and background in biomedical research is essential. Prior specific experience in clinical research and prior publication is desirable but not necessary. Strong interpersonal skills, as well as the ability to function in a team environment are essential. Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Merck's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. To be considered for this position, please visit our career site at www.merck.com/careers to create a profile and submit your resume for requisition # CLI002139. Merck is an equal opportunity employer, M/F/D/V - proudly embracing diversity in all of its manifestations. Search Firm Representatives Please Read Carefully: Merck is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via-email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.




Job Title: Director of Research and Development
Company: BIOTECH MILLS
Location: Snow Hill, NC

Description:
Conduct research for develop of bast fiber chem JOB_IO=7566192 DR_GHJ_4lzvMy51uuYeUrZc00Ero7sHYAKOIs8gXiK7tJjepjENBAB5yu7YYhagKuywpAO Director of Research & Development for textile mftr, Snow Hill, NC. Conduct research for develop. of bast fiber chem., enzyme & natural fiber treatments; identify sources of raw materials; provide tech. advice/assistance; devise testing methods. Req: Bach. deg (or equiv.) in Textile Engg. +10 yrs. exp. in job or related field, incl. at least 5 yrs in exec./managerial posits. invol. research w/i the textile industry; must have knowl. of chem., enzyme, & natural fiber treatments; foreign travel req. Fax resume to Biotech Mills, Inc., Register to View .




Job Title: Director Clinical Research-CLI002252
Company: Merck & Co. Inc.
Location: Gwynedd, PA

Description:
Director Clinical Research-CLI002252 Description Merck is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well as animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. Responsible for the development and execution of the Clinical Pharmacology strategy for a given program from preclinical candidate approval through the worldwide marketing application. Key member of the early development team, providing a leadership role on the team with regard to design and execution of early clinical development strategy. Responsible for Clinical Pharmacology activities for a given program Authors initial program clinical plans, the early development plan, Clinical Pharmacology Phase I studies through Phase Ib Responsible for timely and safe execution of CP program studies. Ensure appropriate technical transfer of experimental medicine qualified platforms. Interact closely with internal and external clinical study support staff and scientists (including discovery research, biostatistics, drug metabolism, regulatory affairs, and global clinical trials operations). Provide Clinical Pharmacology support for programs through the worldwide marketing application filing including supportive registration documents and presentations. Responsible for clear, timely communication and interpretation of Clinical Pharmacology results Franchise, Function, and governance committees. Qualifications M.D or M.D./Ph.D, plus Board Certification or Eligibility is preferred. Demonstrated record of scientific scholarship and achievement. A proven track record in clinical medicine and background in biomedical research is essential. Prior specific experience in clinical research and prior publication is desirable but not necessary. Strong interpersonal skills, as well as the ability to function in a team environment are essential. Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Merck's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. To be considered for this position, please visit our career site at www.merck.com/careers to create a profile and submit your resume for requisition # CLI002252. Merck is an equal opportunity employer, M/F/D/V - proudly embracing diversity in all of its manifestations. Search Firm Representatives Please Read Carefully: Merck is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via-email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.




Job Title: Director Clinical Research - Respiratory/Inflammation TA
Company: AstraZeneca
Location: Wilmington, DE

Description:
of Primary Responsibilities: The Director/Associate Director of Clinical Research reports to TA Clinical Director- Late Development and provides medical input to all aspects of product development. Duties:- Primarily deployed to an Established Brands Team but may also be deployed to teams supporting emerging respiratory and inflammation therapeutics as determined by the TACD and project Medical Science Directors. Responsibilities will be determined by level of experience. Serves as a source of medical expertise for Therapy Area and product teams. Provides input to decisions of the Therapy Area that may have medical and scientific and marketing implications relative to his/her expertise.- Responsible (in collaboration with other Product Team members) for the medical input to design, planning, initiation and completion of phase IIB, III, IIIB and Phase 4 clinical trials and study protocols.- Responsible for the preparation of medical components of Product Plans, IND and other FDA communications under the direction of the Medical Science Director .- Responsible for establishing communications with clinical investigators and thought leaders in his/her particular field of expertise, particularly those who will be willing and able to assist in the evaluation of AstraZeneca's products in accordance with Product Team objectives.- Attends appropriate scientific meetings to maintain his/her awareness of research activities in his/her area of expertise.- Applies strategic intent of AstraZeneca when working with FDA, opinion leaders, prescribers and consumers of AstraZeneca products.- Performs product safety medical reviews for assigned investigational and marketed products as designated by the Medical Science Director. -Provides medical and specialty expertise for safety surveillance of assigned AstraZeneca investigational products.- Works with Therapy Area management Team, Product Team Leadership, Product team members, and Product Strategy and Licensing groups responsible for creation of promotional materials and support of scientific and promotional communications.- Works with internal and external customers, including Therapy Areas, Product Teams, PS&L, FDA-DDMAC, KOLs to insure AZ development and commercial objectives are met. Ensures an appropriate level of customer service to internal and external customers.- Assumes other duties as assigned by the Medical Science Director and TA Clinical Director. Leadership Capabilities: * Passion for Customers * Thinks Strategically * Acts Decisively * Drives Performance Graduate of a recognized school of medicine with an M.D. degree or equivalent.- Specialty training and board certification or eligibility in Pulmonology or Allergy.- Familiarity with biostatistics. Demonstrated clinical research experience in an academia or industry.- Excellent written and oral communication, interpersonal, and organizational skills.- Ability to travel nationally and internationally. Preferred Background: Board eligibility/certification in Pulmonology or Allergy.- Background in clinical or basic science/translational research desirable. Two to three years experience in drug development/medical affairs (required for Director). Knowledge of CDER regulations regarding evaluation and approval of pharmaceuticals (regulatory interaction experience required for Director). An understanding of US pharmaceutical safety reporting and surveillance (required for Director). Individuals with less experience may be considered for an Associate Director level role. Leadership Capabilities: * Works Collaboratively * Develops People & Organization




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