Director Of Research Jobs

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: 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: Senior Director Clinical Research- Respiratory/Inflammation TA Company: AstraZeneca Location: Wilmington, DE Description: 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. 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

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: 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: 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

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/Associate Director Clinical Operations Company: The Judge Group Location: Princeton, NJ Description: Director or Associate Director Clinical Operations needed in the Princeton area. BS or BA degree in life sciences with at least 7 years of experience in clinical research in a Biotech or closely related industry. Must have experience with global trials in sepsis critical care or infectious disease. Experience with clinical studies involving complex design issues; knowledge of relevant FDA and ICH regulations and guidelines; proficient user of MS Word Excel PowerPoint and Outlook; excellent project management problem solving and oralwritten communication skills are essential. Responsible for contributing to the clinical development strategies of the projects from IND to NDA filing. Responsible for the design and execution of one or more clinical development protocols potentially to include the preparation of IND dossiers and the registrational dossiers on a regional or worldwide basis clinical development plans investigator's brochure and protocols for Phase I Phase II and Phase III clinical trials. Primary responsibility will include management of internal and external resources to execute clinical programs from design through patient recruitment and subsequent reporting of final data. This may include management of timeline and budget management of Contract Research Organizations and internal staff. Oversees all aspects of the clinical operational plan and ensures compliance with good clinical practices GCPs and regulatory guidelines. Review and design protocols; evaluate safety and efficacy data; analyze and summarize data for presentation to senior management and regulatory agencies; development of studyrelated documents and training materials. Resumes to Register to View Learn more about The Judge GroupView all of our career OpportunitiesVisit us online at www.judge.comSend this Job to a Friend Celebrating 40 Years! Position Information Company:The Judge Group Location:Princeton, NJ 08540 Status:Full Time Employee Job Category:Biotech/R&D/Science Contact Information Company:The Judge Group Email:Apply by Email

Job Title: Senior Director, Clinical Research – CV Research Company: Gilead Sciences Location: Foster City, CA Description: Job Posting Title:Senior Director, Clinical Research CV Research Requisition Number: 3759 Country: US State: California Job Location: Foster City Functional Area: CLINICAL Position Type: Regular Shift: Days Specific Responsibilities: This position is based in the CV/Metabolic Clinical Development Therapeutic Area, a rapidly growing franchise with development programs in pulmonary artery hypertension, angina, congestive heart failure, glycemic control, resistant hypertension, and arrhythmias. Essential Duties and Job Functions: * Provide leadership and medical expertise within the Clinical Department and the Cardiovascular Therapeutics Division. * Lead and design protocols. * Evaluate safety and efficacy data. * Analyze and summarize data for presentation to senior management and regulatory agencies. * Provide assistance and Support in managing relationships with regulatory affairs, biometrics and other non-clinical departments within Gilead. * Provide strategic guidance and designs on non-regulatory clinical trial plans Knowledge, Experience and Skills: This role requires an MD or MD/PhD. * Three (3) years experience (minimum) with a proven success record in clinical research studies and trial design is required. * Cardiology or pulmonary experience necessary and formal cardiology Training preferred. *Pharmaceutical/Biotech industry experience in clinical drug development necessary. * Experience with clinical studies involving complex design issues. * Knowledge of relevant FDA and ICH regulations and guidelines. * Proficient user of MS Word, Excel, PowerPoint and Outlook. * Excellent project management, problem solving and oral/written communication skills are essential. * Strong leadership qualities; must work well in a team environment. * Strong writing skills. * Ability to work in a matrixed environment.