Director, Clinical Research Resume Sample

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Clementine Kassulke
184 Justice Mountains,  Los Angeles,  CA
+1 (555) 769 7396

Work Experience

Director, Clinical Research
05/2016 - PRESENT
Dallas, TX
  • Leads financial management of City of Hope’s internal, industry, and sponsor-supported clinical trials, including project setup, invoicing, expense allocation, project financial management and project closeout
  • Creation and implementation of policies, procedures, and internal controls for clinical research financial management
  • Interacts, establishes cooperative working relationships, and communicates effectively with co-workers and personnel in other departments, particularly Medical Center Clinical Departments, Clinical Trials Support Services, Clinical Trials Office, and Patient Financial Services
  • Create and implement policies, procedures, and internal controls for clinical research financial management
  • Assist with interpretation of policies and procedures, both sponsor and Institutional, as they relate to compliance with laws, Medicare Coverage Analysis, National Coverage Decision, statutes and regulations dealing with clinical trial billing issues
  • Zero (0) to three (3) years’ experience with a proven successful record in clinical research studies and trial design is required
  • Participates in clinical research operations including initiation of clinical trials to optimize tactical and clinical value through global site selection and data portability
  • Manage and facilitate development/review of all critical clinical study documents, including clinical protocols, informed consent forms, or other study-related clinical documents
Associate Director, Clinical Research
03/2010 - 02/2016
Dallas, TX
  • Work with trial sites to ensure expedient patient recruitment in conjunction with CRO
  • Work with clinical operations team to ensure all clinical study activities are completed in accordance with applicable regulations and guidance; ICH GCP, and Avanir SOPs
  • Work with Clinical Development to draft/provide input on study protocols, conduct ongoing review of data and be able to interpret the data for final reports
  • Manage study budgets and be able to provide accurate forecasting
  • Develop and implement SOPs for clinical trials and related activities, as required
  • Ensure compliance with all applicable regulatory standards related to global clinical trials and interactions with physicians
  • Develop and maintain professional relationships with academic and community-based study sites
  • Interface with departments within and outside of R&D including Finance, Regulatory Affairs, Legal Affairs and Medical Affairs
  • Manage staff and outside partners/service providers
Associate Director Clinical Research Informatics
03/2004 - 11/2009
Detroit, MI
  • Related experience in the biotechnology / pharmaceutical industry, including 8+ yrs. management exp
  • Experience with all aspects of management of clinical trials from inception to completion
  • Strong knowledge of FDA and ICH regulations
  • Previous clinical trial site management experience
  • Understanding of statistics and statistical methods
  • Knowledge of Good Clinical Practice (CGP)
  • Perform long-range planning and the deployment of critical administrative resources toward positioning the University of Arizona’s College of Medicine – Phoenix units to provide comprehensive and efficient support for clinical research
  • Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed Oncology drugs


Iowa State University
1998 - 2003
Science's Degree in Relevant Life Science

Professional Skills

  • Strong relationship building and matrix management, strong team work and strong communication skills
  • Prior significant experience and proven success in enabling and broadly administering clinical trials and clinical research
  • Skilled in public communication, speaking, and relationship skills
  • Clinical trial experience in the setting of pharmaceutical industry with demonstrated experience and involvement in clinical trial design or execution
  • Demonstrated communication skills and effective interaction with executive leadership
  • Excellent language skills in both English and Chinese (fluent in verbal and written)
  • Oncology Clinical trial experience within industry; demonstrated experience and involvement in clinical trial design or execution

How to write Director, Clinical Research Resume

Director, Clinical Research role is responsible for leadership, research, oncology, design, medical, matrix, organization, travel, training, integration.
To write great resume for director, clinical research job, your resume must include:

  • Your contact information
  • Work experience
  • Education
  • Skill listing

Contact Information For Director, Clinical Research Resume

The section contact information is important in your director, clinical research resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:

  • First and last name
  • Email
  • Telephone number

Work Experience in Your Director, Clinical Research Resume

The section work experience is an essential part of your director, clinical research resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous director, clinical research responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular director, clinical research position you're applying to. The work experience section should be the detailed summary of your latest 3 or 4 positions.

Representative Director, Clinical Research resume experience can include:

  • Work closely with research coordinators to monitor protocols, including reporting of serious adverse events occurring within the facilities
  • Manage CRO’s and other vendors; monitoring and audit activities to ensure studies compliance with GCP/ICH guidelines
  • Develop study specific training documents and investigator’s brochures
  • Experience depending upon credentials, in pharmaceutical clinical research or clinical scienctific background, preferably with experience in neuroscience and especially dementia (e.g., Alzheimer’s disease)
  • Partners with Study’s research staff to understand data management and systems needs and translates requirements to appropriate parties (i.e., vendors, consultants, internal resources)
  • Develops annual research operation budgets and strategic initiatives aligning with PHC’s strategic plan

Education on a Director, Clinical Research Resume

Make sure to make education a priority on your director, clinical research resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your director, clinical research experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.

Additional details to include:

  • School you graduated from
  • Major/ minor
  • Year of graduation
  • Location of school

These are the four additional pieces of information you should mention when listing your education on your resume.

Professional Skills in Director, Clinical Research Resume

When listing skills on your director, clinical research resume, remember always to be honest about your level of ability. Include the Skills section after experience.

Present the most important skills in your resume, there's a list of typical director, clinical research skills:

  • Demonstrated leadership/management skills with respect to achievement of company goals and objectives
  • Demonstrated experience with European clinical data requirements and CE marking, EUMDD, MEDDEV 2.7.1 Revision 4 and other relevant regulations
  • Demonstrated experience interacting directly with FDA and Notified Body staff
  • Strong demand for innovation mindset with a priority on insight into the “patients” reality
  • Persuasive, effective and flexible in personal interactions at all levels, with strong oral and written communication capabilities
  • Prior experience in an academic health center or hospital

List of Typical Experience For a Director, Clinical Research Resume


Experience For Associate Director, Clinical Research Resume

  • Institutional review of new protocols, assistance in preparation of hospital budget components, documentation of institutional and IRB approval, preparation/execution of institutional study agreements and oversight of study billing
  • Leading by example to encourage others to prioritize personal and professional development
  • Serving as Study Director and driving the execution of the study from protocol concept to final report including interpretation of clinical data
  • Serving as the Medical Monitor for a study or clinical program, reviewing and monitoring study safety data
  • Demonstrating high ethical behavior at all times, whether dealing with colleagues, vendors, patients, or physicians
  • Assisting with the database cleaning (eligibility listings, patient profiles, listings, laboratory results, etc.)
  • Directing the integration of the Clinical Development Plan (CDP) and the Drug Development Plan
  • Serving as the Medical Monitor for a study or clinical program, reviews and monitors study safety data

Experience For Director Clinical Research Resume

  • Implementing strategies to identify, monitor and resolve clinical/program trial issues
  • Reviewing 3rd party (contractors, consultants and vendors) work product and deliverables to approve payment of invoices and resolves issues
  • Complying with all applicable laws/regulations of each country in which we do business
  • Assisting with the preparation of the publications (abstracts, articles, etc.) pertinent to the study
  • Supports the planning of advisory board meetings
  • 5 Preparing clinical sections of IND annual safety report and annual Investigator Brochure updates
  • Represent the Palm Beach Market as liaison related to research compliance

Experience For Associate Director Clinical Research Informatics Resume

  • Monitor compliance with all policies and procedures as they relate to research and clinical trials
  • Oversee HIPAA process and monitor/audit studies as required for compliance
  • Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD and Regional Operations
  • The position requires coordination and alignment with the regional and broader organization
  • Provide extensive medical and scientific input into the design of clinical trials for these development programs
  • Serve as a medical monitor for clinical studies (provide medical oversight; answer eligibility questions; review safety and adverse event information), working closely with cross-functional team members to ensure planning and execution of trials to meet key milestones, timelines and keep budget targets
  • Assist in the preparation of clinical study protocols and FDA/EMA documents (eg., INDs, annual reports, meeting requests, briefing books, and NDAs) and other relevant clinical documents
  • Establish strong Scientific Advisory Groups of external thought leaders to support the development of compelling clinical development strategies and help optimize program plans and study protocols
  • Contributes to the efficient operations of all clinical research on campus, by actively contributing to and supporting the Mercy Medical Center vision. Functions as main contact in support of clinical research development

Experience For Senior Director, Clinical Research Resume

  • Contributes to the decision-making process and attainment of organization goals through participation in committees as assigned. Maintains accurate records and completes reports according to established system/department policy and procedures and in accordance with all contractual obligations to funding agencies
  • Consults with and provides updates for the Regional Executive Director, Oncology and Cancer Center Medical Director(s) regarding program development, clinical research budget, and necessary authorizations
  • Leads, promotes, and supports research development at Mercy Medical Center. Works to create a vibrant and productive clinical research environment at Mercy Medical Center. Assures that initiatives fit Mercy Medical Center strategic plans, programmatic aims, and operational goals and objectives
  • Selects, trains, develops and evaluates staff. Plans and coordinates continuing education for the staff. Addresses inadequate performance and disciplinary issues in a timely manner and holds staff accountable through performance improvement plans; consults with Human Resources department when appropriate
  • Serves as a main point-of-contact for all Mercy Medical Center faculty interested in pursuing funded research, providing guidance and actively participating in the preparation of proposals and publications
  • Upon request, evaluates research proposals for their quality and for possibilities, and when appropriate, of intramural and extramural funding. When requested, advises investigators regarding experimental design, analysis of data, and possibilities of funding
  • Identifies relevant, appropriate funding sources for clinical research initiatives

Experience For Senior Director, Clinical Research Services Resume

  • Identifies appropriate national, regional and local funding sources for clinical programs and research initiatives; builds relationships with program officers at sources of funding to determine potential interest in research
  • Regularly reviews requests for proposals, such as those from the NIH, the federal register, private foundations, industry (i.e., pharma and device companies), and from the State of Massachusetts, Connecticut and local government agencies
  • Collaborates with the Regional Executive Director, Oncology to identify and prioritize possible funding sources for programs/initiatives
  • Oversees effective and efficient function of Research Administration at Mercy Medical Center. Ensures that Mercy Medical Center is compliant with Federal regulations related to research involving Human subjects
  • Provides support to Graduate Medical Education (GME) program in areas of human subjects protections, research compliance, scientific integrity and ethics, and scientific method and design
  • Ensures compliance with regulations and policies by members of the medical staff and other staff participating in research involving human subjects. Provides advice to investigators and hospital officers
  • Work requires close understanding of Federal, state and local laws and regulations governing the performance of clinical research involving human subjects
  • Maintains proficient knowledge of federal regulations. Contacts and consults with federal agencies and accreditation body (AAHRPP) as needed
  • Identifies and implements mechanisms for improving high-functioning research operations in a cost-effective manner (e.g., electronic IRB submissions; coherent support from Finance)

Experience For Director Clinical Research Operations Resume

  • Work requires the analytical ability necessary to design highly complex operational systems and programs; resolve problems requiring knowledge of state‑of‑the‑art technology, understanding of literature in a professional, technical or scientific field; and skill in developing financial and operating plans for a large department
  • Work requires the ability to manage the colleagues within assigned department and to persuade and negotiate with peer level managers and department heads on issues and programs that impact assigned unit/department
  • Work requires demonstrated excellence in writing and communication
  • Effectively communicate information through the planning and execution of meetings and presentations and present recommendations to senior staff. Accountable for strategy development and execution for specified clinical area
  • Critical review of vendor proposals and contracts to include CRO agreements and medical writers to ensure program success. Financial approval of contracts and expenses at specified level
  • Prioritization across teams to ensure strategic goals/milestones within Clinical Research, are met

Experience For Associate Director Clinical Research Resume

  • Oversight of contract and budget development to support clinical research, including the production of reports to evaluate research operations
  • Provide leadership for day-to-day operations and staff activities to support clinical research implementation and ongoing study conduct through the Center for Clinical & Translational Science and the UMass Memorial Medical Center
  • Provide guidance to clinical investigators and clinical research staff on individual study projects, focusing on feasibility, initiation issues and best practices
  • Provide leadership related to external industry relationships, including interacting with pharmaceutical and device companies when potential trial opportunities are presented
  • Oversee and review approval of all clinical research-related Confidentiality Agreements, Data Use Agreements and Clinical Trial Agreements and maintain signature authority for these documents
  • Collaborate with Vice Provost and Center for Clinical & Translational Science to set educational priorities; participate in education and training of clinical research staff across the institution
  • Detail-oriented, with good organizational, prioritization, and time management proficiencies
  • Experience in clinical research in either academic or industry setting

Experience For Director, Clinical Research Dermatology Resume

  • Leadership, supervisory and talent development experience
  • Manage staff, including hiring, performance appraisals, employee development, performance improvement, and termination
  • Expert knowledge and understanding of federal, state regulations and guidance related to clinical research
  • Lead/support the creation of clinical strategies and development plans for assigned programs in Phase I, II, or III of development, in consultation with cross-functional team members and outside consultants, to meet all requirements of the product development strategy
  • With an MD, based on credentials, in pharmaceutical clinical research in Neuroscience within Industry or a CRO, preferably with experience in dementia (e.g., Alzheimer’s disease) or other Neurodegenerative Diseases

Experience For Director, Clinical Research Operations Resume

  • Works closely with the KAI Research, Inc. senior management team to plan, direct, review and implement all aspects of organization's strategic objectives, clinical research implementation, business development, and policies/SOPs
  • Serves as liaison with outside medical and scientific experts; interacts with company clients; participate as technical expert for strategic or marketing decisions. Attends conferences to represent KAI and actively market KAI’s services. Meets with prospects to present KAI’s capabilities and value proposition
  • Lead, direct or provide subject matter expertise, general oversight, monitoring, guidance, and quality assurance for planned and ongoing projects/studies and implementation of clinical research regulations and policies
  • Coordinates and manages the development of general and study specific guidelines
  • Develops, designs and implements clinical trial protocols, informed consent forms and CRFs for Phase I-IV clinical trials, and interfaces with principal investigators
  • Confers with biostatistician to assess and makes recommendations to clients on statistical issues including statistical analysis plan, randomization scheme, safety monitoring and reporting characteristics for client sponsored clinical trials
  • Provides leadership and participates in writing and editing of clinical study reports, draft presentations and manuscripts, and other research, scientific and technical documents
  • Advise on best practices for DMCs/DSMBs
  • Provides review, analysis, and categorization of clinical studies, and grants for clients

Experience For Site Director, Clinical Research Resume

  • Interview and hire research support staff; Responsible for resource allocation and development of assigned research staff; Reviews and approves timesheets; Evaluates employee performance
  • Guide and lead clinical research management teams, coordinate research staff, and ensures appropriate integration of cross-functional team members to achieve project objectives and meet budget goals
  • Lead the troubleshooting process to reach resolutions for any issues that arise during course of a study
  • Create department processes and procedures documentation in order to support continuous project quality and portfolio management
  • Identify and qualify opportunities for KAI within government and commercial business sectors, present to senior management team for review, and participate in business development go/no go decisions. Lead and participate in the writing of proposals and bid defense. Provide background information and determines tasks, schedules, and resources
  • PhD or MD/PhD in Health Sciences
  • Six to ten years’ experience in the drug or device clinical research process that includes, but not limited to study design, budget development and management, clinical research project management with multi-site trials, data analysis, regulatory requirements and scientific writing
  • Demonstrates expertise in a variety of the industry's concepts, practices, and procedures, including experience in interactions with FDA, regulatory agencies and the medical/scientific community

List of Typical Skills For a Director, Clinical Research Resume


Skills For Associate Director, Clinical Research Resume

  • Support pre-clinical development planning, patho-mechanistic insight and translational medicine efforts to effectively advance pipeline programs
  • Proven experience in clinical research, performance improvement methods, and compliance improvement
  • Demonstrated experience with oversight of IDE clinical studies, and PMA organization, preparation and review
  • Previous experience of clinical research/clinical development is highly desirable, including strategy development, medical monitoring and protocol/CSR writing
  • Establish good working relationships with product line leaders, physician investigators, referring physicians, research staff and clinic staff
  • Demonstrated career history of managing and developing staff
  • Eight (8) years in clinical research administration demonstrating progressive leadership experience required

Skills For Director Clinical Research Resume

  • Research financial and billing compliance management experience required
  • Experience with clinical studies involving complex design issues
  • Experience running IDE studies
  • Lead teams to ensure appropriate interpretation and dissemination of all evidence generated, based on EDS, including CSRs, CERs, abstracts, manuscripts, etc
  • Experience conducting industry sponsored drug development trials

Skills For Associate Director Clinical Research Informatics Resume

  • Leading a clinical team and working with cross-functional teams required
  • Facilitating collaborations with external researchers around the world
  • Facilitating collaborations with external researchers around the world; and
  • Strategic Plan, Portfolio Planning and Operating Plan. Identify opportunities and provide leadership to Business Planning teams to support business needs
  • Through transparent leadership, be a key leader in developing a high-performing team with a global culture
  • Set achievable goals and targets, (including financial, clinical, educational and safety) for each team in each product line
  • Travel on company business about twenty (20) percent of the time to manage future or ongoing clinical research projects
  • Applied knowledge/understanding of the Quality System Regulation (QSR)
  • Serves as a medical/scientific consultant to marketing or research project teams and government regulatory agencies

Skills For Senior Director, Clinical Research Resume

  • Establishes the conditions essential for determining the safety, efficacy, medical usefulness, and marketability of drug or medical device products candidates
  • Deep understanding of China regulatory environment and clinical development procedure
  • 25–30% of working time, domestic and international
  • 10-20% of working time, domestic and international
  • Responsible for Clinical R&D activities for multiple and / or complex projects, including
  • Expresses commitment to City of Hope’s mission, personally identifies with its vision and takes pride in shared success
  • Knowledge and understanding of 21 CFR 50, 56, 312, 812 (FDA) regulations regarding management and execution of human subject research, current training in human subjects protection
  • Detail-oriented, organized, and a self-starter; self-disciplined and able to work independently

Skills For Senior Director, Clinical Research Services Resume

  • Attend appropriate scientific meetings to maintain his or her competency and to maintain awareness of research activities in his/her area of responsibility
  • Author detailed development documents, presentations, budgets, and position papers for internal and external audiences
  • Applied knowledge of FDA regulations and ICH GCP guidelines
  • Designs and provides oversight of clinical research programs
  • Builds relationships with key opinion leaders and applies their input to enhance study design and protocols
  • Ensures that clinical research program design meets scientific objectives and is aligned with commercial needs
  • Interprets results of Phase I-IV investigations in preparation for new-drug or medical device application
  • Manages the budgetary/financial process including the LBE, LRP, Update, and Plan processes. Ensures that the organization is meeting the budgetary goals and updating scope/direction as appropriate

Skills For Director Clinical Research Operations Resume

  • Accountable for achievement of both performance and financial goals for overall area of responsibility
  • Responsible for having superior leadership and coaching skills to build relationships throughout the Division (particularly with R&D and QA/RA) and motivate the Clinical Research team
  • Guides, directs and serves as a role model for the organization, coaches staff and establishes succession plans for key positions
  • Review and monitor all budget areas. Determine and approve actions to deal with variances to meet the overall needs of the Clinical Research Organization and the Division
  • Accountable for interactions with FDA or other regulatory agencies regarding clinical research issues
  • Ensures goals are aligned with long term needs of the division. Aligns functional goals with long range business needs and strategies
  • Responsible for continuous improvement initiatives and leverages new appropriate technology consistent with regulatory and compliance strategies; assures appropriate training and education programs are in place. Tracks appropriate metrics to ensure the effectiveness of these programs

Skills For Associate Director Clinical Research Resume

  • Maintains, promotes and models social, ethical and organizational norms and adherence of the Clinical Research Organization to code of compliance conduct and ethical principles
  • Responsible for making timely decisions which reflect a consideration of the facts and data at hand which are in alignment with overall Division's goals
  • Clinical development or affairs representative for worldwide project team. Daily interaction with director, project manager, directors in multiple cross-functional areas, including finance, R&D, and/or regulatory affairs
  • Demonstrated knowledge of Federal Regulations pertaining to Human Subject Protection including: 45 CFR 46, 21 CFR 50, 21 CFR 56, 21 CFR 312 and 21 CFR 812
  • Critically reads and evaluates relevant medical literature with deep understanding of the data and status from competitive products
  • Has and maintains deep scientific, technical and clinical expertise in respiratory medicine and related areas

Skills For Director, Clinical Research Dermatology Resume

  • Understands and keeps updated with the pre-clinical, clinical pharmacology and data relevant to the molecule of interest
  • Maintains visibility within the Immunology & Inflammation Therapeutic Area to maintain credibility with internal and external stakeholders
  • Ensure that all development activities are proactively planned and targeted towards timely achievement
  • Interacts with opinion leaders and consultants
  • Owns (in collaboration with Project Team), the “Extended synopses” for individual studies CDP and clinical sections of IDP and is responsible Clinician for the implementation of clinical strategy
  • Influences the definition of the product value proposition (in collaboration with respective functions)and the focus of the research strategy, by providing input on existing clinical needs and approaches to clinical development strategies for research projects
  • As CDPs are sophisticated documents that require the ability to integrate highly complex scientific, medical and operational information, strong scientific, medical and analytical skills are required
  • Opportunity to lead a global registration phase III trial in solid tumors
  • An innovative and open-minded approach to problem solving is critical to arrive at the optimal solution for complex development challenges

Skills For Director, Clinical Research Operations Resume

  • M.D or M.D./Ph.D who is Board Certified or Eligible in Oncology (and Hematology)
  • Our Company commitment to the oncology portfolio with establishment of an Oncology Business Group that is responsible for the full cycle of development. Seamless execution of projects via end-to-end accountability from discovery to NDA/BLA/MAA filing
  • Autonomous environment that empowers the Oncology Business Group to drive the product portfolio and be accountable for performance; High visibility within Eisai Inc. as the key interface with novel target cancer research
  • Relevant experience in Oncology Therapeutic Area
  • Openness to external innovations enhanced by active collaborations with external talents

Skills For Site Director, Clinical Research Resume

  • Medical expertise in internal medicine (specialty training and board certification, eligibility or expertise in endocrinology/diabetology or cardiovascular disease/hypertension [eg., cardiology/nephrology] would be a strong positive)
  • Six or more years of relevant pharmaceutical/biotech-industry experience in clinical research and development, ideally with experience across Phases 1-3 and post-approval
  • Ph.D, ideally focused in Neuroscience or a related area with prior pharmaceutical industry clinical research experience
  • PhD, ideally focused in Neuroscience or a related area with prior pharmaceutical industry clinical research experience
  • Strong capability of work prioritization and deliver results with parallel multiple tasks

List of Typical Responsibilities For a Director, Clinical Research Resume


Responsibilities For Associate Director, Clinical Research Resume

  • Assisting the project team clinical lead in planning, implementation, managing and reporting of CDPs and programs
  • Identifying, monitoring and resolving clinical program/trial issues, and reporting progress to management
  • Acting as lead medical monitor for the GT clinical programs, conducting site visits as needed, having detailed understanding of patient level data
  • Assisting the Clinical Lead and/or Study Director in the planning and implementation, execution, day to day managing and reporting of clinical trials
  • Serving as a Study Director for selected trials and delivering final protocol, implementation strategy and clinical data review plans
  • Developing Clinical Protocols to meet the objectives of the CDP
  • Implementing the development strategy for the GT clinical programs from early phase studies up to the global submissions and beyond

Responsibilities For Director Clinical Research Resume

  • Making the appropriate budgetary allocations to targeted opportunities
  • Interpreting study data and developing integrated summaries for safety and efficacy
  • Contributing clinical expertise and content to regulatory documents (e.g. briefing books, NDAs, etc.)
  • Setting key deadlines and project milestones within function
  • Making appropriate budgetary allocations to targeted opportunities
  • General familiarity with biostatistics; expert in navigating scientific literature, interpretation of data, display of data

Responsibilities For Associate Director Clinical Research Informatics Resume

  • Work independently and work with a matrix team environment required
  • Provides significant and meaningful Clinical support to business unit leaders
  • Work and interact with key clinician’s external to the organization – represent the division and Clinical Research in a positive manner to external contacts/KOLs
  • Develops internal teams, provides leadership and guidance to the larger Clinical organization; mentors, coaches, develops their employees worldwide
  • Provides strategic guidance to Quality
  • Manages cross-functional teams within the Clinical Research organization. Direct the design, planning, development and monitoring of all clinical evaluation projects or clinical studies as directed by your manager. Interact and lead scientific, clinical, and business activities at trial sites for the division
  • Direct team to ensure that clinical studies and/or clinical evaluations of those products determined to satisfy medical needs and/or commercial potential are conducted
  • Take the lead role in the development of the clinical planning and/or strategy. Define the clinical plan by establishing the appropriate clinical protocol for the desired product claim or indication
  • Establish and maintain appropriate systems to ensure adherence to ICH/GCP, risk management, and/or quality system guidelines including training and successful results from independent audits

Responsibilities For Senior Director, Clinical Research Resume

  • Generate clinically/scientifically sound statistically analyzed data to confirm performance claims supporting regulatory submissions and to ensure that the product conforms to defined user needs and/or requirements
  • Review the clinical studies sections for regulatory submissions to ensure adequacy of support for all claims pertaining to safety, efficacy, clinical performance and Independent Review Board or ethics committees. Prepare quality regulatory submissions for U.S. and non-U.S. regulatory agencies
  • Provide compliance guidance on the conduct of clinical research, risk management, and/or clinical evaluation division-wide, for developing and overseeing a quality training program and for compliance in all audits of the Clinical Research organization
  • Represent the Division's clinical research programs and results at Global Regulatory Agency meetings, Advisory or Panel Committee meetings and in discussions with senior management and trade meetings
  • Serving as the SME to provide input to project teams across functions, presenting at Advisory Board meetings, and liaising with KOLs regarding protocol study strategy and issues
  • Participating in the selection of new compounds for clinical development and IND filings in Neuroscience (especially in the area of dementia therapeutics) through technical evaluation of licensing and/or partnering opportunities. This includes developing and implementing paradigms for novel data analyses
  • Develop, author and execute on study protocols and amendments by investigating the literature, searching databases and other existing/investigational products, working with key opinion leaders, clinical trial investigators, and internal scientific, pharmacology and regulatory teams

Responsibilities For Senior Director, Clinical Research Services Resume

  • Review the data generated during the execution of a study to gather a medical understanding of the safety and efficacy results. Perform the role of Medical Monitor for one or more studies. Present results to Safety Monitoring Committee and other internal and external meetings
  • In collaboration with medical writing and biostatistics, contribute to the drafting of clinical study reports and other documents reporting data. Participate in the ongoing data reviews e.g. blinded reviews and later data outputs. Recommend additional analyses
  • Provide medical insight to the draft responses to regulatory agencies and
  • Build and maintain a good knowledge of the existing data for our product and the literature about the target disease. Be aware the publications on competitive products
  • Perform any other assigned task as requested by management
  • Partners in a manner consistent with Amicus’ beliefs

Responsibilities For Director Clinical Research Operations Resume

  • Perform all responsibilities in compliance with company SOPs
  • A combination of credentials and personal attributes including medical training, clinical practice, industry drug development experience, strong work ethic, and integrity are necessary for success in this role. Specifically, Amicus is seeking
  • Providing input on clinical development plan, clinical trials, medical affairs launch preparation, publication planning, training, and health outcomes strategic planning
  • Interacting with external customers, thought leaders, strategic alliances, key organizations, and institutions through active participation in external events and activities to strengthen Eisai’s medical reputation through successful management of medical dimensions of products
  • Assisted by related Sanofi Genzyme functions (e.g. clinical operations, project management, and procurement), responsible for defining timelines, budgets and contingency/risk management plans to assure successful execution of the clinical trials
  • Creates updates and maintains operational metrics and analytics reporting process including the communication of such metrics and analytics

Responsibilities For Associate Director Clinical Research Resume

  • Represents his/her project at key regulatory agency meetings as the medical spokesperson for the studies and project
  • Ensures timely submission and dissemination of clinical data
  • Establishes and maintains appropriate collaborations with knowledge experts
  • Serving as the clinical/medical team expert to provide direction to all project team functions, organizing Advisory Board meetings (e.g., agenda setting), and identifying and liaising with KOL regarding program strategy and scientific advice
  • Interpreting study data and developing integrated summaries for safety and efficacy. Contributing clinical expertise and content to regulatory documents (e.g. briefing books, NDAs, etc.)
  • Serving as the clinical/medical team expert to provide direction to all project team functions, organizes Advisory Board meetings (e.g., agenda setting), and identifying and liaising with KOLs regarding program strategy and scientific advice

Responsibilities For Director, Clinical Research Dermatology Resume

  • Leading and mentoring a team of direct reports, in addition to cross functional study teams, providing coaching, training, career development and effective feedback
  • Facilitates the development and operations for a multi-facility/subsidiary shared services function
  • Selects, orients, and trains new team members. Ensures competence of assigned team members and compliance with regulatory requirements, organizational policy, and performance requirements. Forecasts staffing needs, defines position requirements and ensures team member development needs are met
  • Builds and fosters collaborative relationships with other departments/service-lines within the organization and external stakeholders to stay informed and abreast of new initiatives, products, and services; identifies opportunities to support organizational initiatives, quality, efficiency, effectiveness and world class service excellence
  • Oversees key projects, processes and performance reports, data and analysis; forecast requirements, analyzes variances and initiates corrective actions
  • Develops and implements ongoing quality and operational process improvements through the demonstration of quantifiable clinical and operational outcomes, safety management and operational efficiency
  • Partners closely with senior executives and service-line management to enable growth strategies
  • Updates job knowledge by participating in educational opportunities; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices, participating in professional societies
  • Primary responsibilities include providing high level input to complex Phase I-IV clinical trial protocol design and clinical study reports as well as Health Authority inquiries

Responsibilities For Director, Clinical Research Operations Resume

  • Provides ongoing clinical monitoring for clinical trials including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance
  • Working knowledge of the IND/NDA process acquired through direct industrial experience is required
  • Experience in direct personnel management
  • More than 5 years of clinical or scientific, or more than 10 years industry, experience within respiratory drug development
  • Opportunity to lead a global registrational trial in solid tumors
  • Experience with electronic health record systems and clinical trial management systems required
  • Experience in pharmacovigilance processes in the conduct of GT studies and patient follow-up post-GT
  • Experience on teams with early and late stage development products
  • Experience in clinical research in the pharmaceutical industry

Responsibilities For Site Director, Clinical Research Resume

  • Contributing to the Clinical Development Plan (CDP) preparation for the GT clinical programs
  • Training new CRO monitors and CRAs on protocol and processes
  • Assisting with the preparation of the NDA documents
  • Leads two or more specific components of cross-functional strategic initiatives
  • Providing hands on tactical work, in project teams and working in collaboration with relevant team members and peers to ensure the highest level of execution for the GT clinical program
  • Working with Clinical Trial Investigators and clinical research organizations, to collaborate on trial site selection, training and ongoing conduct of the study
  • Ensuring that studies are performed with the highest quality. Performing data review and analysis, presentations (oral and written) of clinical data, authoring and editing of clinical study reports
  • Maintaining highest level of medical science and clinical development expertise in Amicus’ fields of interest
  • Successfully interact with experts and other external partners in a manner consistent with Amicus’ beliefs

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