Director Of Project Management Jobs

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-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, Clinical Operations Company: Prometheus Laboratories Inc. Location: San Diego, CA Description: GI Clinical OperationsSUMMARYResponsible for the planning, implementing and managing of all operational aspects of clinical trial projects in compliance with applicable regulations and SOPs.ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.Responsible for execution of all phases of clinical development programs and projects, including, but not limited to: development and management of budgets, protocol development, study feasibility, site selection, interactions with investigators, obtaining IRB approval, maintenance regulatory documents, monitoring and communicating the progress including recruitment status, and making recommendations to senior managementServes as key interface and partner with all partner organizations, contract research organizations (CROs), clinical sites, and other service organizations involved in the conducting of clinical trial programsManages and communicates to senior management overall clinical strategic operational plan for projects including timelines, internal and external resources/costs, key deliverables and key data issuesOversee the conduct of drug development and diagnostic product clinical studies to ensure compliance with applicable regulationsWork with therapeutic area and cross-functional teams to create development plans including clinical timelines and budgets in support of marketed products and projectsParticipate in project and product team meetingsProvides strategic planning expertise, drafts the operations components, and ensures operational feasibility of clinical development plans and scenarios, including budget and resource estimatesManages the preparation of clinical study reportsCoordinates and drives completion of the protocol concept, final protocol and template informed consent formIdentifies and provides solutions and direction related to key cross-functional, sponsor-site, and sponsor-CRO clinical trial issues.Develops outsourcing specifications for vendor requests for proposal and scope of work agreements; participates in and guides study team in vendor selection and management throughout the life of clinical projectsAuthors and refines clinical operations plans and study monitoring plans.Works with study teams to determine patient recruitment strategies and operational feasibility and implementation of study objectivesPlans, convenes, runs and presents at investigator meetingsMaintain up-to-date knowledge of regulations, guidelines and pharmaceutical industry standards and practices with regard to clinical trialsEDUCATION and/or EXPERIENCEPosition generally requires a BS with a minimum of 12 years relevant industry experience, or MS degree or PhD strongly preferred with a minimum of 8 years relevant industry experience, MD with a minimum 3 years preferred but not required. Significant experience with the planning and implementation of diagnostic and pharmaceutical clinical trials including CRO and investigator/site evaluation and selection, protocol and case report form development, study initiation including investigator meetings, study conduct, monitoring and clinical study report preparation required. Experience in execution of GI, Oncology and/or autoimmune clinical trials preferred. Thorough understanding of FDA, ICH, and GCP guidelines, as well as a thorough understanding of cross-functional clinical processes including data management, biostatistics, medical writing, drug safety, and regulatory affairs.San Diego ,CA 12 Bachelors

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, Research & Therapy Acceleration Program Company: Leukemia and Lymphoma Society Location: White Plains, NY Description: Director, Research & Therapy Acceleration The Leukemia & Lymphoma Society (LLS) is the world's leading private organization funding leukemia, lymphoma and myeloma research. Our mission: Cure leukemia, lymphoma, Hodgkin's disease and myeloma, and improve the quality of life of patients and their families. The LLS funds exemplary projects across the entire research continuum relevant to improved outcomes for blood cancer patients, from basic laboratory science through the development of new diagnostics and treatments to clinical trials, and from investigator-initiated research to multi-disciplinary academic collaborations and private-sector drug development alliances. The LLS is determined to be deliberate and purposeful in finding and supporting research that is most likely to help patients, as soon as possible. To date, LLS has invested more than $750 million in research aimed at helping all blood cancer patients live longer, healthy lives. We will continue to support research through our innovative and integrated funding program, until every patient has a safe and effective therapy. The LLS's Therapy Acceleration Program (TAP) addresses some of the hurdles associated with blood cancer therapy development, with focused efforts that reduce investment risk and accelerate clinical progress. We are offering a once in a lifetime opportunity to be a part of LLS's new and exciting research program for this rapidly expanding part of our organization. Combined with LLS's existing research grant program, TAP contributes to our end-to-end strategy for developing new blood cancer therapies. We are seeking proactive, creative, "Out of the Box" thinkers who are thoughtful in optimizing funds and driving our core objective finding cures! Position Description: This position brings scientific expertise to the identification and evaluation of new blood cancer research opportunities; and project management expertise to the oversight of ongoing projects in the LLS research portfolio. The incumbent has substantial scientific and project management experience and works as a member of the LLS Research Department in our White Plains, NY headquarters. Major Position Responsibilities: Provide scientific and/or project management support for the Sr. Director of TAP including the identification and evaluation of potential research opportunities; perform on-going evaluation of existing alliances and prepare materials for internal committee meetings Manage several on-going research partnerships, working closely with members of the LLS Research group and external partners/ collaborators to manage project milestones. Manage the project budgets including detailed accounting and program records according to external auditing standards. Identify and evaluate external contractor support (e.g. contract research organizations, drug or biologicals manufacturers, and project evaluation consultants). Work closely with LLS research team to monitor and shape the research strategic plan Represent the LLS Research Department as needed at scientific, medical and business meetings. Work with various LLS divisions to communicate research priorities and accomplishments. Position Requirements: Experience with oncology research; familiarity with blood cancer research is desirable but not a requirement. Experience with drug discovery and/or development process Documented strong project management skills and ability to multi-task Documented ability to think strategically while maintaining attention to project details. Familiarity with maintaining budget records Strong interpersonal and communication skills including presentation skills; enjoys working as part of team. Education: PhD or the equivalent in Biomedical Sciences, or related fields. Experience Requirements: A minimum of 5 years of relevant post-doctoral scientific experience which includes oncology research experience. Demonstrated project management experience in a relevant biomedical research program. Pharma/Biotech or related CRO experience focusing on drug discovery and/or clinical development is desirable. If interested, please send CV and cover letter to Paulette Damiano: Register to View Equal Opportunity Employer

Job Title: Director, Clinical Research Administration and Operations Company: Duke University Location: Durham, NC Description: Director of Clinical Research Administration and OperationsDuke Comprehensive Cancer CenterDuke University is seeking a dynamic Director of Clinical Research Administration and Operations for the Duke Comprehensive Cancer Center and its emerging Duke Cancer Institute.The Director will report directly to the Chief Academic Administrative Officer for the emerging Duke Cancer Institute/Associate Director for Administration for the Duke Comprehensive Cancer Center.The Director will also work very closely with the Center's Deputy Director for Clinical Research, the Medical Director overseeing oncology clinical trials and the Associate Vice President for Oncology Services of Duke University Health System to successfully administer the Center's Clinical Research Division, which includes site-based and affiliated clinical research.This senior management team approach and partnership are critical to the success of the mission of the Duke Cancer Institute and the Duke Comprehensive Cancer Center. The Director will be charged with providing constructive and forward-thinking leadership for all components of oncology clinical research, including but not limited to pre-award research development, post-award research administration, staff education and training, health disparities and community engagement, regulatory compliance, IRB processes and issues, and clinical trials operations (accrual growth/management strategies, hospital/University partnerships, space, technology, and compliance).The Director will also oversee the Center's NCI-designated shared resources supporting clinical research and lead initiatives to increase the quality and efficiency of these shared resources. Salary is commensurate with experience and academic preparation.Qualifications: Advanced degree in business administration, health administration, or a related discipline CCRP certification required.Additional professional certifications preferred Seven or more years experience in a similar administrative leadership role within an academic health science center/University/Medical Center directly engaged in the administration of clinical research programs and clinical trials Significant knowledge and involvement in the development of translational research programs, clinical research protocol review systems and processes, clinical trials operations, and regulatory compliance is required Excellent overall knowledge and involvement in clinical research support functions (pre and post-award, sponsored programs administration and compliance, clinical trials management systems, safety desks, monitoring, protocol review, etc) Excellent communication and leadership skills Highly collaborative and energetic management style Experience with building strong partnership between university and health systems functions related to clinical research Proven track record in increasing diversity of clinical trials populations, increasing community engagement/partnerships, and addressing health disparities is highly preferred Job Duties:Oversee the clinical research administration function of the Duke Comprehensive Cancer Center and emerging Duke Cancer Institute.Recommend and implement procedural and process changes to improve the effectiveness, efficiency and compliance of the clinical research mission.In partnership with the Medical Director for the Oncology Clinical Trials Shared Resource and Associate Vice President for Oncology Services for Duke Health System, oversee the administration of site-based and affiliated clinical research.Work closely with the Research Practice Manager and Finance Practice Manager of the Oncology Clinical Trials Shared Resource to enhance operational performance, increase the quality of support to clinical investigator, and strengthen regulatory and institutional compliance.Lead efforts to increase diversity of clinical trial populations.Work with University and Health System leadership to increase clinical trial accruals with specialized effort to increase the accruals of minorities and under-represented communities.Develop internal educational and training programs/standards centered around improving clinical research administrative services, engaging community involvement in the education of the benefits of clinical research, and participating in targeted outreach and education efforts with external audiences.Provide strong leadership in the development, implementation and improvement of clinical trial management systems and patient population screening tools/systems.Represent Duke University at professional organizational meetings, conferences and symposiums.Serve in external leadership capacities within professional organizations.Through continuous improvement, identify, communication and implement best practices for clinical research administration.Be an advocate for clinical researchers in working with the IRB and other University-based committee and processes engaged in clinical research.Help resolve issues between IRB and clinical investigators.Promote translational and collaborative research.Advise leadership on barriers and opportunities for improvement.Oversee the operations of all 17 NCI-designated shared resources within the Duke Comprehensive Cancer Center.Work with the Shared Resources Committee to address operational and performance issues of the shared resource, labs and services.Work in partnership with the Director of Basic Research for the Center to streamline operational functions and services.Ensure compliance to NCI standards and requirements associated with the Center's NCI designation as a Comprehensive Cancer Center.Participate in the oversight of the Cancer Center Support Grant as it relates to clinical research and provide input for progress report development and grant application preparation.Other duties as assigned.Minimum QualificationsEducation Bachelor's degree in nursing, pharmacy or other allied health care discipline including appropriate certification/licensure (i.e., RN, PA, or RPh) required. OR Bachelor's degree in a life science field (i.e., biology, chemistry, zoology, etc.) acceptable for those candidates who possess a minimum of 10 years directly related experience and extremely strong clinical knowledge. Prefer a Master's degree or other post-graduate training in a clinical discipline or business/health care administration (MSN, PharmD, PhD, MD, MBA, MHA, MPH).Experience 7 years of experience in clinical trial operations in an academic medical center, or in the pharmaceutical, medical device, biotechnology, or contract research industry. 3-5 years in a project management capacity and 1-2 years in a personnel management capacity (of professional/ technical/ clinical staff). Strongly prefer experience in a variety of therapeutic areas and in managing large international trials. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

Job Title: CPMC-Project Director-Research Institute* Company: Sutter Health Location: San Francisco, CA Description: Company: Sutter Health Location: San Francisco, CA Status: Unspecified Category: Science/Research Position Type: Full-Time, Employee Company: Sutter Health Reference Code: CPMC-1007677 CPMC-Project Director-Research Institute* In 1991, two of San Francisco's oldest and most respected medical institutions, Pacific Presbyterian Hospital and Children's Hospital of San Francisco, merged to form California Pacific Medical Center. Davies Medical Center joined in 1998 and became the center's third campus. In January 2007, California Pacific Medical Center and St. Luke's Hospital merged. Today, with its 1,304 licensed acute care beds and 25 residential beds, California Pacific Medical Center is one of the largest private, not-for-profit academic medical centers in California. California Pacific Medical Center affiliated with Sutter Health in 1996 and is accredited by the Joint Commission on Accreditation of Healthcare Organizations. The CPMC - Research Institute is a dynamic group of scientists, research staff, and administrators who specialize in biomedical, clinical and behavioral research. We are the research component of the California Pacific Medical Center, the largest medical center in San Francisco. In the US, CPMC ranks 3rd in the top twenty-five in total NIH funding to independent hospitals. PRIMARY PURPOSE: (Position Summary) This position is for a project director of a large clinical trial comparing ultrasound and CT scans. The incumbent will join a large and collegial coordinating center for clinical research and will be responsible for leading a team to implement and oversee this trial, including the implementation of scientific aims. Position is grant funded. SUPERVISION: (Reporting Relations) The Project Director reports to the SFCC Director and will supervise research staff. Education: Masters in a related field required, PhD preferred Knowledge: Extensive background in public health, epidemiology and biostatistics Skills: Microsoft Access, HTML, SAS statistical program PLEASE APPLY USING THIS BUTTON ONLY Not Available

Job Title: Medical Director- Clinical Research - Ophthalmology Company: Diedre Moire Corp. Location: Boston, MA Description: Director regional medical research specialist-ophthalmology needed to represent company on new drug (ND) presentations and investigator meetings. Oversee medical monitoring in selected sites of selected regions. Required experience: Conducting clinical trials in hospital institution and clinics, biotech consulting companies, directing clinical and pre-clinical pharmacology studies involving infectious diseases, AER (adverse effect reactions) and SAER (serious adverse effect reactions). High-profile position with opportunity to become part of executive team. This is your chance to join a top biomedical company growing at a rapid rate. Incredible career growth opportunities because we promote from within and groom for executive management. Benefits include bonuses, stock options, 401(k), Major Med, Prescription, and more. We are prepared to relocate individuals from your location. For complete details contact Mr. Borges at: Register to View ext 242 Or submit resume online at: http://dmc9.com/bxb/app.asp Or email to: Register to View WE ARE AN EQUAL OPPORTUNITY EMPLOYER and our employment decisions are made without regard to race, color, religion, age, sex, national origin, handicap, disability or marital status. We reasonably accommodate individuals with handicaps, disabilities and bona fide religious beliefs. Jobs Career Position Hiring. We will make every effort to consider applications for all available positions and shall use one or more of the contact methods and addresses indicated in resume or online application. Indicated location may be proximate or may be desirable point of embarkation for paid relocation to another venue. CONSIDERED EXPERIENCE INCLUDES: Clinical Field Engineer Biomedical Equipment Clinical Research Associate Biomedical Implants Director Medical Doctor Medical Director Physician Clinical Research Studies Clinical Research Manager Clinical Research Director Medical Devices Implants Grafts CRA Clinical Studies Biomedical Cardiac Orthopedic North American Job Bank www.najobbank.com If you submit an application or resume, which contains your email address, we will use that email address to communicate with you about this and other positions. We use an email quality control service to maintain security and a remove and dead address filter. To cancel receiving email communications, simply send an email from your address with the word "remove" in the subject line to Register to View If you have further concern regarding email received from us, call Register to View . We will be glad to have a real human being contact you upon request.

Job Title: Director of Clinical Operations Company: Clinical Staffing, Inc. Location: Chicago, IL Description: Overseeing clinical trials and clinical personnel (CRO experience preferred) About Us Clinical Staffing Inc. is a national Pharmaceutical recruiting firm that focuses on Clinical Personnel such as CRA's,Data Management, Regulatory Affairs and Quality Assurance. Our clients are Pharmaceutical, Biotech and CRO companies. We cover all over the US with majority of the jobs located in NJ,PA,California and Mass. areas. Provide positive leadership to effectively manage the activities of Clinical Operations and supervise staff within in a local office and associated region in a manner that ensures all milestones and quality targets are met and that costs are kept under control. Co-ordinate & manage the activities of multiple projects and project teams in a manner that ensures all timeframes and targets are met and that costs are kept under control. Additional responsibilities will include: Recognize, exemplify and adhere to company values which center around commitment to People, Clients and Performance Actively participate in the selection and recruitment of suitable and qualified staff. Participate in clinical project manager training as a presenter/facilitator. Assist with management training for other departments as Clinical Operations representative, as necessary Ensure the local office and its staff reporting through that office (including regional based clinical staff) operate in a professional and client orientated manner Enforces company s project governance system; keep senior management informed of project status in relation to quality, cost and timelines. Collaborate closely to ensure Administrative, Human Resource, Finance and IT activities are appropriately delegated and managed, as required Demonstrate development, motivation and mentorship of Associate Directors, Project Directors and Managers in multiple locations, as required. Support/conduct performance appraisals and assign responsibilities as appropriate for staff in local office or associated through the regional office. Ensure all necessary training is provided to local staff to improve their job performance and knowledge Present a high profile role within the organization always displaying a positive attitude and offering constructive input as required Assesses and assists manager with study and departmental metrics, as applicable Maintain positive, strong working relationships with clients, vendors and staff. Directly manage one or more clinical project(s) Act as a therapeutic specialist / Clinical Operations strategist /Key Operations Lead in the development of oncology proposals and in Bid Defense preparation and presentations Liaise and takes the lead with other departments/managers to improve the effectiveness of the organization Manage complex assignments in a variety of areas of responsibilities, simultaneously. Ensure appropriate project(s) profitability inclusive of optimizing staff utilization/recovery Ability and willingness to travel approx. 25%-50% of the time (international and domestic). Other duties as assigned Overview of Experience & Qualifications Minimum of a Diploma or Degree in life sciences and/or 8-10 years relevant work experience. To Apply Directly: Email your resume to: Jesse Gill at: Register to View Toll Free: Register to View

Job Title: Associate Director Clinical Research- Respiratory/Inflammation TA Company: AstraZeneca Pharmaceuticals Location: Wilmington, DE Description: Watch our employee profile video to learn more about what is it like to work at AstraZeneca Length: 1:00 min You can at AstraZeneca. AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity. We have received many honors, including: Fortune World's Most Admired Companies list (2009) Woman Engineer Magazine's 18th Annual "Top 50 Employers" (2008) The Times Top 100 Graduate Employers (2007-2008) CEO Cancer Gold Standard Reaccreditation, CEO Roundtable on Cancer (2008 & 2009) 100 Best Companies for Working Mothers by Working Mother Magazine (2002 - 2008) 100 Best Companies to Work For in America by Fortune Magazine* (2008) *Only large pharmaceutical company included on the list Diversity MBA Magazine Top 50 Companies in Diversity Leadership (2008) Men's Fitness Top 15 Fittest Companies in America (2008) The Scientist Best Places to Work in Industry (2008) Fit-Friendly Company Award, American Heart Association (2007) Top Employer, Science Magazine (2002 - 2007) Associate Director Clinical Research- Respiratory/Inflammation TA Job Summary External Summary of Primary Responsibilities: Summary of Primary Responsibilities: The Senior Director of Clinical Research reports to TA Clinical Director- Late Development and provides medical input and leadership 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 and leadership for Therapy Area and product teams. 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 as well as supervision of research physicians supporting projects.- Responsible for team leadership and preparation of medical components of Product Plans, IND and other FDA communications, regulatory briefing and submission documents, advisory boards and publication plans as delegated by 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. Internal Summary of Primary Responsibilities: Summary of Primary Responsibilities: The Senior Director of Clinical Research reports to TA Clinical Director- Late Development and provides medical input and leadership 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 and leadership for Therapy Area and product teams. 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 as well as supervision of research physicians supporting projects.- Responsible for team leadership and preparation of medical components of Product Plans, IND and other FDA communications, regulatory briefing and submission documents, advisory boards and publication plans as delegated by 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. Requirements 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 & Organization We want you to build a balanced life at AstraZeneca. Your career is just one part of that. We offer competitive salaries, rewards and recognitions for your invaluable time and e