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
