MEDIPOST America- Associate Director, Clinical Development

  • May 21, 2016 9:00 AM
    Message # 4032132
    Anonymous member (Administrator)

    Title: Associate Director, Clinical Development

    Employer reference CDJ-2016/1

    Position Summary This is a unique opportunity to join MEDIPOST America at a time of

    (human Umbilical Cord Blood-derived Mesenchymal Stem Cell

    Products)

    Major Duties & Responsibilities The ideal candidate will have a clear understanding of the drug

    tremendous growth and acceleration in MEDIPOST’s allogeneic

    Cord Blood-derived Stem Cell product development and launch in

    various parts of the world.

    This is a fast-paced and dynamic work environment where the

    Clinical Scientist will assist in the design and execution of Allogeneic

    Cell Therapy clinical programs in the field of Orthopedics,

    Neonatology and Neurodegenerative Disorders.

    The Associate Director, Clinical Development may serve in various

    roles including leadership roles in project management of clinical

    trial design, execution and Regulatory Affairs.

    S/he will work in a cross-functional environment with external

    representatives as well as Late-Stage Product Development and

    Launch. S/he will contribute to and support Clinical initiatives to

    improve the quality and content of all clinical programs as well as

    the cross functional/organization processes designed to effectively

    deliver our R&D portfolio.

    development process (especially early phase clinical trials), protocol

    writing & study conduct, the principles of translational medicine,

    and how to work effectively within cross-functional teams ensuring

    their success.

    Specific duties and major responsibilities include;

    1) Preparation of Key product documentation

    * Assist in the creation of the protocol concept sheet (PCS) and the

    full protocol with support and input from other key team members

    such as the clinical development physician, Clinical Operations,

    Biostats, Translational, PK, and Regulatory.

    * Assist in the creation and maintenance of the Clinical

    Development Plan (CDP) for assigned programs ensuring alignment

    with the Target Product Profile (TPP), taking into account

    operational feasibility, regional requirements, personalized

    healthcare (PHC) strategies and future payer considerations.

    * Assist in the development of key documents to support the

    components of a regulatory submission (i.e. IND Annual reports, IB,

    MEDIPOST America, Inc. 9605 Medical Center Dr. Suite 109, Rockville, MD 20850 (T) 301-605-1081 (F) 301-605-1086

    Briefing book for pediatric implementation plan).

    * Become familiar with the latest thinking regarding mechanism of

    disease, diagnostic tests, treatment, drug development trends, and

    regulatory requirements in assigned disease and therapeutic areas.

    2) Data Review

    Developing the key elements of data review plans (in collaboration

    with Data Management) for clinical studies and performing medical

    data review during study execution to ensure integrity of accruing

    study data including:

    * eCRF development

    * Compliance of enrollment with Inclusion/exclusion criteria.

    * Monitoring of end-point data (i.e. safety and clinical activity)

    recorded in eCRF.

    * Review of physical Exam, Medical history and concomitant

    medication.

    * Protocol Deviation review.

    * Coding reviews.

    * Table and Listing review

    Under the supervision of the Medical Monitor, lead the collection

    and analysis of Serious Adverse Events including but not limited to:

    * Lead the real-time collection and review of SAE information

    received from clinical sites

    * Interact with study sites to complete the medical data on the SAE

    * Prepare SAE narratives for inclusion in Clinical Study Reports and

    regulatory submissions

    * Assure the SAE assessment, including source data, is fully

    documented in the TMF

    * Facilitate the reconciliation of clinical and safety databases

    3) Operational Support for Clinical Studies

    Provision of Clinical Development input into the tactical execution

    of clinical protocols by working collaboratively with colleagues in

    relevant functions e.g. Clinical Operations/ Biostats etc. Activities

    are expected to include:

    * Involvement in the selection of clinical research sites and service

    providers.

    * Interacting with CRAs from CROs.

    * Working with third party vendors to ensure protocol end-points

    are collected appropriately.

    * Participation in Investigator meetings and other scientific

    committees as required by the protocol (e.g. independent reviews,

    Data Safety Monitoring Boards, Steering Committees, etc.).

    * Study risk mitigation and highlighting of potential issues and

    solutions.

    * Training CRO personnel and investigational sites to ensure

    protocol requirements are met.

    MEDIPOST America, Inc. 9605 Medical Center Dr. Suite 109, Rockville, MD 20850 (T) 301-605-1081 (F) 301-605-1086

    * Establishing and approving scientific methods for design and

    implementation of clinical protocols, data collection systems (eCRF),

    and final reports.

    * Ensure study level activities are conducted to allow

    implementation of the study protocol in a manner consistent with

    the current plan/timeline and CDP.

    * Review and interpret study results.

    * Assist in preparing publication of study results.

    4) Internal Collaboration

    Assist in the linkage between Clinical Development and other

    functional groups within MEDIOPST both in Korea and U.S.:

    * Establish strong links between company experts in relevant

    departments, including regulatory and manufacturing, to initiate

    and expedite clinical studies.

    * Assist with the management of and input into Scientific Advisory

    Boards convened to develop CDP strategies as appropriate.

    5) External Collaboration

    Assist efforts to obtain external scientific and clinical validation of

    clinical research protocols by establishing links with outside experts

    to initiate and expedite clinical studies. This may include seeking

    advice from KOLs, regulatory, pricing/reimbursement, and market

    access experts.

    Full / Part time Full-Time.

    Salary $78,000 ~ $98,000 p.a. depending on qualifications and experience.

    Benefits - Employer contribution on 50% of personal health insurance

    Minimum education required for

    the position

    Minimum experience required for

    the position

    premium.

    - Relocation allowance may be offered to the successful candidate

    requiring cross-state relocation.

    - Performance-based incentive may be negotiated upon 12

    months of employment.

    Ph.D. or Master’s degree in health science field, PharmD or other

    relevant advanced degree in a health science field is required.

    Higher degree is preferred but not essential.

    At least 1-2 years of experience in commercial clinical research

    and/or drug development, preferably in the therapeutic area of the

    position.

    MEDIPOST America, Inc. 9605 Medical Center Dr. Suite 109, Rockville, MD 20850 (T) 301-605-1081 (F) 301-605-1086

    Required skills, technology

    knowledge and/or experience

    Employer details www.medi-post.com

    Contact and enquiries Dr. Sophia Yang – Chief Operating Officer

    - Ability to interpret scientific and/or clinical data from scientific

    experiments and/or clinical trials.

    - Good communication skills including scientific writing skills and

    presentation skills.

    - Knowledge on the general concept of pharmaceutical product

    development including clinical trials.

    - Ability to work as an individual and as part of a team.

    - Ability to meet deadlines and be able to work under pressure.

    - Ability to communicate in written and spoken Korean language.

    www.medipostamerica.com

    By e-mail only: sophia.yang@medipostamerica.com

    Apply with Cover Letter, CV and contact details of 2 referees.

    MEDIPOST Executive Summary 2016 05.pdf

    MEDIPOST Job Posting 2016 05.pdf


    Last modified: May 24, 2016 1:56 PM | Anonymous member (Administrator)
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