Director, Clinical Development Resume Sample

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Dawson Leffler
92708 Spinka Corners,  Chicago,  IL
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Work Experience


Director, Clinical Development
05/2016 - PRESENT
Dallas, TX
  • Monitor compliance with DaVita’s product formularies and ensure contact terms are met
  • Travel up to 10%-20% of the time
  • Medical specialty and sub-specialty training and certification (or eligibility) highly desirable in cardiology
  • Experience in clinical research and/or cardiovascular drug development in academia / government, pharmaceutical or CRO environment
  • Clinical or research experience (in an academic, pharmaceutical or CRO environment) related to the design and/or conduct of clinical studies in cardiology is required
  • Cardiovascular development experience required
  • Ensuring alignment between the Core Team, ClinicalSub‐team and Clinical Trial Team(s)
  • Developing the proposed clinical milestones with the Clinical Sub‐team
Associate Director, Clinical Development
11/2010 - 12/2015
New York, NY
  • Working towards the achievementof defined project stage gates and milestones
  • Overseeing all clinical development activities in collaboration with the Clinical
  • Sub‐Team and Clinical Trial Team(s)
  • Ensuring that decisionsmade by the Clinical Sub‐team have functional backing
  • Communicating to the Core Team leader, Core Team and relevantfunctions any potential issuesor risks (e.g., changes or significant risks to the Clinical Development Plan, new safetyconcerns) upon identification in a timely manner
  • Providing Clinical Development oversight on clinical development aspectsfor ongoing clinical trials
  • The abilities to work on a team, cooperate with colleagues, and effectively communicate with a diverse audience, at multiple levels, both inside and outside the company, are essential
  • A capability to work with cross-functional teams at the protocol and clinical program level is mandatory
  • Excellent human relations and communication (written and oral) skills are required
Director Clinical Development
12/2006 - 06/2010
Chicago, IL
  • Effectively resolves conflicts between individual needs and requirements of the organization
  • Demonstrates the ability to analyze complex situations and proactively identify opportunities/issues; effectively solves problems that cross functional boundaries
  • Site selection & activation
  • Protocol compliance, safety reporting, & data quality
  • Timely data entry and query management
  • Action item resolution
  • Adherence to PSMP

Education


Oklahoma State University - Tulsa
2002 - 2006
Science's Degree in Finance

Professional Skills


  • Excellent oral and written skills, strong interpersonal and listening skills
  • Work proactively and effectively, with demonstrated creative problem solving skills
  • Excellent communication and interpersonal skills and the ability to facilitate constructive, expedient problem solving
  • Proven strategic planning and communication skills across multiple disciplines
  • Excellent interpersonal communication skills (written, verbal, and presentation) is required
  • Proactive and effective work style, with creative problem-solving skills
  • Clinical research or clinical development experience, with previous experience leading a clinical development team or processes

How to write Director, Clinical Development Resume

Director, Clinical Development role is responsible for leadership, training, negotiation, english, reporting, integration, database, auditing, oncology, planning.
To write great resume for director, clinical development job, your resume must include:

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

Contact Information For Director, Clinical Development Resume

The section contact information is important in your director, clinical development 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 Development Resume

The section work experience is an essential part of your director, clinical development 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 development 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 development position you're applying to. The work experience section should be the detailed summary of your latest 3 or 4 positions.

Representative Director, Clinical Development resume experience can include:

  • Pharmaceutical industry experience as industry physician
  • Experience in the preparation of regulatory applications (e.g. IND, CTA, NDA, MAA, and agency meeting packages) is required
  • Experience in clinical research and/or oncology drug development in pharmaceutical or CRO environment
  • Experience with development of clinical trial protocols, CSRs, abstracts, and manuscripts is required
  • Developing external advocates for the company’s technology, products and direction
  • Monitor and interpret data from internal and external studies, assessing the medical and scientific implications and making recommendations

Education on a Director, Clinical Development Resume

Make sure to make education a priority on your director, clinical development 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 development 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 Development Resume

When listing skills on your director, clinical development 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 development skills:

  • Demonstrated leadership and team building skills as well as the ability to perform effectively in a multi-disciplinary environment.
  • Excellent communication skills (oral and written) and organizational skills
  • Effective leadership, management, strategic, technical, analytical, problem-solving and negotiation skills
  • Work effectively in a multi-disciplinary team setting and employ a team approach to decision making
  • Scientific writing skills with the ability to produce written communications with clarity, accuracy and rigour
  • Directly related experience in clinical/scientific experience including leadership or management role within the device industry

List of Typical Experience For a Director, Clinical Development Resume

1

Experience For Associate Director, Clinical Development Resume

  • Experience leading the development or execution of clinical effectiveness research or technology assessments
  • >5 years experience in clinical trials, medical affairs and/or post-marketing support
  • Previous experience collaborating with Blue Plans and departments within BCBSA
  • Understanding of running clinical trials from concept study idea to publication
  • Medical monitoring of clinical studies; review and approval of protocol deviations and medical data on an ongoing basis
  • Team Player: Works in a team setting complementing other team members to achieve the desired results
  • Interacts with advisory board members to assure implementation of the latest clinical thinking and guidelines into clinical development plans
2

Experience For Senior Director, Clinical Development Resume

  • Supports business development activities, including due diligence activities
  • In-depth knowledge and thorough understanding of FDA, EU, and global regulations, ICH guidelines, and GCPs that govern clinical research
  • Comfortable and capable of multi-tasking both internally driven and externally directed projects
  • Report to and assist Chief Medical Officer by directing activities involved with regulatory authorities and key opinion leaders
  • Contribute to the development of strategic initiatives, including various organizational initiatives in Clinical Development
  • Serve as the clinical development expert on several cross-functional teams, including DST, Clinical Collaborations, new pipeline molecules, ISTs and others
  • Applies clinical/medical decision making to clinical development issues
3

Experience For Director Clinical Development Resume

  • Board Certification in Neurology, Psychiatry, or equivalent CNS training is required
  • 3 years managing Clinical Development group)
  • Progressive responsibilities in clinical drug development in industry setting
  • Protocol risk assessment & issue management
  • Oversight of key risk indicators
  • Adherence to industry regulations, guidelines, & Companies processes (SOPs & WIs)
  • Maintain study and site inspection readiness at all times
  • Significant clinical research experience within a site management operations & monitoring leadership role in the pharmaceutical/device industry or CRO (preferably within a medium/ large CRO).Search Jobs US
4

Experience For Medical Director, Clinical Development Resume

  • Provide clinical strategies, evidence development plans and study design and protocol development with cross-functional teams including Marketing, Health Economics, Regulatory and R&D
  • Provide strategies to support data dissemination to meet the needs for market registrations by authorities, reimbursement clinical and product marketing and further device development
  • Serve as group leader with new product development and marketing leaders to set priorities in in portfolio
  • Provide input on strategic decisions and ensure clinical affairs representation in core product development team meetings and activities
  • Leads and directs clinical affairs activities to ensure completion of all deliverables for product development activities. This includes pre-clinical studies, risk management implementation, new product development processes and design history file development as clinical affairs team members
  • Knowledge of GCP, Drug Safety, MedDRA safety coding and Pharmacovigilance processes
  • Oversees design and implementation of studies for product development stage medical devices
5

Experience For Executive Director, Clinical Development Resume

  • Strong basic science or clinical research background in academia or pharmaceutical development experience, preferably in hematology/oncology, or completion of specialty certification in hematology/oncology
  • Lead the project scientists, ensuring appropriate training, mentoring, and supervision across the assigned study/studies within the clinical development program
  • Work closely with functional partners (Data Management, Biostatistics, Regulatory, GCO, QMMC, GMS) to ensure an integrated and strategic approach to flawless execution and systematic oversight of study protocol(s) in late development in close collaboration with key functional stakeholders
  • Provide support for clinical study/studies within a development program including
  • Provides oversight for all assigned BU projects to ensure study launch, conduct and closeout occurs according to the Customer’s and company's contractual agreement. Ensures studies progress according to internal and Customer quality standards, SOPs, GCPs and ICH guidelines to fulfill all federal and local regulations
  • Works with senior management and Business Development to set strategic direction for BU to better target types of projects across selected customer segments, makes recommendations, and drives strategy execution for successful business growth
  • Actively manages and mentors Project Management staff in leadership skills, customer management skills, project management skills, Trusted Process compliance, and for project specific tasks. Ensures appropriate training and development is provided to all assigned staff
6

Experience For Senior Director, Clinical Development, Immuno Resume

  • Oversees process for execution of master service agreements, CDA’s, consulting agreements, contracts and other study documents
  • Coordinates Bio study Sample shipments to CRO’s with document preparation and regulatory requirements for sample shipment
  • Provide medical and strategic leadership for programs that integrate the individual’s extensive knowledge in basic and clinical science, neurology, and input from the medical community around the world
  • Relevant drug development experience, either within industry or as a clinical investigator/physician scientist in academia, or equivalent experience
  • Proven clinical development strategist with experience designing, implementing and conducting clinical trials, with emphasis on proof-of-concept and first-in-human studies
  • Demonstrated ability to develop and maintain excellent working relationships with both internal colleagues and external contacts, including key thought leaders, and investigators
  • Demonstrated ability to work well in teams in a cross functional manner
  • Develops clinical development plans, clinical protocols, investigator’s brochures and other key program documents in collaboration with cross functional development teams, with emphasis on scientific and safety matters
7

Experience For Assoc Medical Director, Clinical Development Resume

  • Trains internal and third party team members as appropriate to meet business needs. Participates in the negotiation of timelines and resource needs with both internal and external decision makers. Coordinates and manages activities including auditing and/or co-monitoring of Contract Research Organization’s (CROs) or independent contractors
  • Facilitates communication with CRO’s/ independent contractors and third party vendors. Initiates contracts, approves payments and ensures communication to team of changes to the budget and operating plan
  • Lead clinical development strategies for client programs (compound/portfolio of clinical studies) as appropriate
  • Accountable for all program deliverables and client relationship
  • Key point of contact, point of issue escalation and interface with client company(s) to lead relationship management, clinical strategy support, and if applicable presenting clinical development strategies to governing bodies and oversight committees
  • Interface with the Sarah Cannon Physician Leadership, Scientific Leadership and Development Innovations Leadership Team to coordinate the strategic planning for client clinical programs and to support operational implementation and delivery of the associated clinical studies
8

Experience For Director Clinical Development, Immunology Resume

  • Oversee interdisciplinary clinical research teams (matrix model)
  • Oversight for development and implementation of program plans
  • Ensure studies are conducted in compliance with GCP, relevant SOPs and regulatory requirements
  • Responsible for program management components of inspection readiness for all aspects of the program conduct
  • Responsible for the financial and operational health of all studies within the program or portfolio
  • Proactively identify and manage issues
  • Lead the development of contingency planning and risk mitigation strategies to ensure successful delivery of program goals program management reports for clients and management
9

Experience For Director, Clinical Development Urology Resume

  • Implement resource strategies to achieve program goals
  • Participate in bid defense meetings where presented as potential lead for program activities
  • Support operational excellence by identifying best practices, actively participating in Project Review Meetings, and by making recommendations to senior management
  • Works on new initiatives and special projects as directed by President, Sarah Cannon Development Innovations / Sr. Director, Clinical Development
  • Contribute to the strategic development of clinical programs
10

Experience For Associate Director Clinical Development Resume

  • Prepare manuscripts, abstracts and presentations for scientific meetings and advisory boards
  • Provide strategic leadership for programs that integrate the individual’s extensive knowledge in basic and clinical science, neurology disease areas with knowledge from the medical community around the world
  • As required, establish external collaborative relationships to augment internal Biogen capabilities in support of early-phase development programs
  • Provide strategic leadership for programs that integrate the individual’s extensive knowledge in the disease area, knowledge from the medical community around the world and the commercial, research, regulatory, and medical research goals in the disease area
  • Clinical Science Lead (CSL)
  • Virology-immunology leadership and support for R&D, medical sciences, Medical Affairs, and Commercial lines at global/regional/local levels
  • Virology-Immunology function core representative of Medicine Development Teams (PhIII/IIIb/IV)
  • Create, Support, Present medical and scientific educational and scientific engagement materials

List of Typical Skills For a Director, Clinical Development Resume

1

Skills For Associate Director, Clinical Development Resume

  • Previous experience in late phase registration studies and previous NDA/BLA filing experience in oncology
  • Understands & leverages cross-functional roles & responsibilities to effectively & efficiently accomplish team goals
  • Fluent in verbal and written English communication skills
  • Demonstrated leadership experience
  • Seasoned project management skills; multiple projects of complexity and/or large scale nature
2

Skills For Senior Director, Clinical Development Resume

  • Special Skills/Abilities (for Associate Director and Director except where noted)
  • Excellent leadership experience in a matrix environment
  • Experience developing and implementing various protocols
  • Experience in developing and writing study protocols, study procedure manuals, informed consent forms, clinical study reports, and manuscripts
  • Demonstrated leadership in running a complex clinical research program and ability to bring out the best in others on a cross-functional global team
  • Professionalism, objectiveness, critical thinking, evidence-based reasoning, and a positive outlook are of the utmost importance
3

Skills For Director Clinical Development Resume

  • Demonstrates basic understanding of global pharmaceutical/ device product development environment
  • Experience interacting with global development operations (e.g. clinical operations, regulatory, Quality Assurance) and clinical investigators
  • Demonstrated strategic and critical innovative thinking
  • Strong data-driven thinking and ability to interpret medical/scientificdata and clinical relevance
  • Proven track record of leading studies from early stage through to regulatory submission
  • ADC and Haematology development experience
  • Experience in molecular oncology and/or translational science
  • Experience in Clinical development of Pulmonary diseases is highly desirable
  • Academic and/or pharmaceutical industry experience
4

Skills For Medical Director, Clinical Development Resume

  • Demonstrates a thorough knowledge of worldwide regulatory and safety requirements as pertains to drug development, research projects, and/or market support
  • Industry experience, particularly in development within the disease area (neurodegeneration), is desirable
  • Production cycle management education, certification, or experience
  • Strong leadership profile with executive presence
  • Relevant industry experience, preferably with drug development
  • Active contribution to the Integrated Evidence, Safety Review, and Clinical Matrix Teams
  • Input to Integrated Evidence Generation plan and market access strategy
  • Acting as a key contact for the Core Team, Clinical Sub-team and Clinical Trial Team(s) regarding the scientific/clinical development aspects of a project
  • Ensuring the review of clinical data, including protocol deviations
5

Skills For Executive Director, Clinical Development Resume

  • Interpreting and communicating, with the CPL, clinical trial results
  • Working knowledge of the use of Microsoft suite of software products including Excel and Word is required
  • Providing scientific/clinical oversight for the clinical trial in collaboration with the Clinical Sub-team members
  • Liaising with drug discovery and other matrix research areas
  • Assist in researching and drafting of sections or entire documents, as assigned, such as DSURs, other study reports and documents, investigator brochures, etc
6

Skills For Senior Director, Clinical Development, Immuno Resume

  • Knowledge of carrying out hematology/oncology clinical trials, including knowledge of hematology/oncology treatment options
  • Provides leadership direction and determines and develops approach to solutions by coordinating multiple resources to solve complex problems
  • Medical specialty and sub-specialty training and certification (or eligibility) are highly desirable in medical oncology and/or hematology
  • Collaborate with Medical Science Liaisons and other company staff in identifying key partners for future research studies/projects
  • Establish clinical development timelines, incorporating key decision points and Go/No Go criteria for each clinical development plan
  • Accountable for the design and execution of clinical development plan and clinical studies within that plan, working with a cross-functional team
  • Clinical leadership and disease area expertise in the conduct of global rheumatoid arthritis clinical trials working with a CRO partner
  • Input to trial design, protocol development, reporting & data interpretation and other medical aspects of the clinical studies
7

Skills For Assoc Medical Director, Clinical Development Resume

  • Oversight of medical monitoring of the trials to ensure subject safety and appropriate detection and management of safety related issues
  • Input on behalf of GSK (sponsor) for external vendors, GSK Local Operating Companies, investigators and regulatory agencies
  • Provides status reporting on GSMO deliverables to Senior Management and Cross-functional Groups
  • Clinical leadership and disease area expertise in the conduct of global rheumatoid arthritis clinical trials, working with a CRO partner
  • Therapeutic area knowledge relevant to mechanisms of action of vaccines in remit
8

Skills For Director Clinical Development, Immunology Resume

  • Takes initiative to contribute clinically relevant scientific ideas and knowledge to team globally
  • Understands and leverages cross-functional roles and responsibilities
  • Make connections between organization, team, product, ideas, etc
  • Understand implications of strategic decisions
  • In-depth knowledge of industry, competitors
  • Encourages innovation and efficiency and welcomes change
  • Identifies and resolves complex problems in a solution oriented manner
  • Make tough decisions quickly
  • The position requires research administration experience, knowledge of scientific principles of controlled trials, and a comprehensive knowledge of FDA and ICH guidelines
9

Skills For Director, Clinical Development Urology Resume

  • Conducts briefings and technical meetings for internal and external representatives including equivalent and above management
  • Liaises with other areas of the business providing senior input and advice to global projects
  • Functions as a clinical and subject matter expert in the therapeutic area
  • Uses deep technical and scientific knowledge to advise and develop strategies which significantly contribute to organizational objectives
  • Represents the organization as the primary internal and customer scientific and technical contact as required on contracts and/or operations
10

Skills For Associate Director Clinical Development Resume

  • Responsible for strategy implementation within the subprogram, area or country
  • Develops concepts and proposes approaches to address identified ophthalmic medical device, science and technology needs
  • Supplies technical advice and counsel to other professionals and represents the organization in outside discussions and technical forums
  • Originates and applies complex concepts and proposes new and unique methods and procedures
  • Designs with regular use of creativity and originality to research and/or development
  • Processes assessment feasibility, research, design, development, compliance to customer and non-customer requirements, and transfer to production
  • Lead design reviews and assign and review action items

List of Typical Responsibilities For a Director, Clinical Development Resume

1

Responsibilities For Associate Director, Clinical Development Resume

  • Provide safety oversight during clinical programs and make recommendations based on safety findings to team, as needed
  • Provide strategic input on new product concepts, long-range strategic plans and licensing opportunities in CNS
  • Execute an early stage development program for relapsing and progressive forms of MS
  • Define and manage external partnership(s)
  • Face to face advisory role with Key External Experts
  • Lead interactions with diagnostic and algorithm partners to inform appropriate use of VH medicines
2

Responsibilities For Senior Director, Clinical Development Resume

  • Subject matter expert across the ViiV portfolio research/business development objectives
  • Expert communication of VH data in presentations at scientific conferences, either local, regional, or international
  • Exemplifies transparency and promotes quality of science
  • Execution of medical virology plan and related activities in accordance with business objectives
  • Positive influence on scientific quality and strategic execution across Chief Scientific Medical Office (CSMO)
  • Provide scientific expertise across ViiV Healthcare e.g. CSMO, Commercial, and Government Affairs, Public Policy and Patient Advocacy (GAPPAC) lines
3

Responsibilities For Director Clinical Development Resume

  • Work with the Medical Director and Senior Director, Clinical Development, to interface internally and externally as the primary clinical science lead of assigned studies and programs
  • Design and review clinical protocols, data analysis plans, interpretation of results, clinical study reports, and supporting work for sections of regulatory submissions, such as, INDs, CTAs, NDAs, MAAs and regulatory agency briefing packages, etc
  • Prepare, present, and defend complex aspects of protocol design and/or study data at investigator and internal meetings
  • Prepare and review draft abstracts and manuscripts for publication in consultation with other team members/collaborators
  • Critically analyze and synthesize complex information from reviews of the scientific/clinical literature
  • Assist the Clinical Operations team in evaluating, selecting, and engaging research-oriented investigative sites for company-sponsored studies and future research projects
  • Attend appropriate external scientific events to maintain awareness of research activities and represent a project and/or the company
4

Responsibilities For Medical Director, Clinical Development Resume

  • Participate in cross-functional teams, departmental meetings, and regulatory meetings
  • Offer scientific insights into therapeutic areas and disease specific information as required
  • Knowledge of GCP and regulatory guidelines is required
  • Knowledge of clinical science as applicable to drug development is required
  • Thrive as an individual contributor and a team member in a matrix environment is required
5

Responsibilities For Executive Director, Clinical Development Resume

  • Speak and write in English fluently is required
  • Attention to detail and a commitment to high quality and on-time deliverables are key success factors
  • Perform Literature searches for specific research questions and collate published literature in a succinct manner
  • Lead and demonstrate ownership of the design and implementation of a clinical development program or programs in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, markets, business operations, and emerging issues
  • Integrate the scientific rationale, regulatory requirements, product development plan, and commercial goals to build a solid strategic framework for the clinical development plan
6

Responsibilities For Senior Director, Clinical Development, Immuno Resume

  • Oversee project-related education of investigators, study site personnel, and study staff
  • Lead clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of data pertaining to safety and efficacy of the molecule
  • Present at scientific, medical and regulatory meetings globally
  • Develop and maintain relationships with academic investigators, pharmaceutical partners/sponsors, KOL’s, and patient advocacy groups
  • Contribute to activities in support of the company’s planned NDA submissions. Author clinical sections for INDs, NDAs, and other related documents
  • Partner with pharmacovigilance to assess the safety profile of compounds
  • Maintain a high level of clinical and scientific expertise in the disease area(s) by reviewing the literature, attending medical/scientific meetings, and through personal interchanges with consultants, thought leaders, investigators and internal stakeholders
  • Author manuscripts and collaborate with cross-functional colleagues and thought leaders to meet publication plan objectives
  • Maintain ethical standards of the highest level and have the knowledge and ability to comply with all relevant ethical, regulatory, and legal standards
7

Responsibilities For Assoc Medical Director, Clinical Development Resume

  • As required by program needs, contribute in partnership with Discovery colleagues to the design and implementation of translational strategies
  • Basic knowledge of the pulmonary therapeutic area
  • Working knowledge of Good Clinical Practices, scientific and clinical methodology, protocol design, project management and regulatory requirements for clinical studies
  • Up to 25% travel, both domestic and international, with periods of 50% and more travel
  • Travel 20-30% of the time to various customer and sponsor company locations, both domestically and internationally required
  • Provide leadership and medical input for clinical programs, clinical protocols in development, ongoing clinical trials, clinical study reports and regulatory documents
  • Serve as medical monitor on trials for products under development in Sleep Medicine and CNS
  • Collaborate closely with other internal team members in clinical development, clinical operations, regulatory affairs, drug safety and pharmacovigilance, and quality to facilitate the execution of clinical trials and programs
  • Collaborates with the safety department to monitor the safety of assigned clinical trials and participates in the SAE reporting process
8

Responsibilities For Director Clinical Development, Immunology Resume

  • Leads review of study data, working closely with biostatistics and data management
  • Collaborate closely with study investigators on clinical trial eligibility and subject and patient safety issues
  • Engage external experts to obtain scientific input into clinical program development
  • Review, interpret, and approve safety and efficacy data in clinical study reports, regulatory documents and submissions related to clinical trials (e.g., IND and NDA)
  • Review publication-related materials on Jazz Pharmaceuticals sponsored studies
  • Leads the clinical trial development process for products in the gastroenterology portfolio
9

Responsibilities For Director, Clinical Development Urology Resume

  • Drives and executes clinical strategy in collaboration with the Clinical Operations team
  • Leads program and protocol development in general - responsible for clinical development plans and study designs
  • Provides input/review on study start up documentation, e.g. source data verification plans based on protocol specifications, CRF design and vendor integration plans
  • Plays an active role in investigator meetings and other study implementation meetings
  • Leads data interpretation and presentation to Senior Management
10

Responsibilities For Associate Director Clinical Development Resume

  • Provides oversight to and interaction with the clinical and safety personnel from the clinical CRO
  • Leads preparation of clinical sections of all relevant regulatory filings (IND, study reports, NDA, etc.)
  • Serves as the external face of the program to KOLs, clinical advisory boards, investigators, vendors/CROs and clinical sites
  • Serves as the technical resource for issues raised by internal and external collaborators, investigators, consultants and contract resources
  • Interacts in collaboration with strategic partners
  • Works closely with Medical Affairs in the development of publications, abstracts, and presentations
  • Highly collaborative with team orientation; flexible in personal interactions at all levels of the company

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