Rockville, Maryland 에 있는 Biotech company, MEDIPOST America 에서 다음과 같이 인재를 찾습니다.

POSITION DESCRIPTION

Title: Associate Director, Clinical Development
(human Umbilical Cord Blood-derived Mesenchymal Stem Cell Products)

Position Summary

– This is a unique opportunity to join MEDIOPST America at a time of 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.

Major Duties & Responsibilities

– The ideal candidate will have a clear understanding of the drug 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, 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.
* 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.

Minimum education required for the position:

– 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.

Minimum experience required for the position

At least 1-2 years of experience in commercial clinical research and/or drug development, preferably in the therapeutic area of the position.

Required skills, technology knowledge and/or experience

– 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.

Employer details: http://www.medi-post.com / http://www.medipostamerica.com

Contact and enquiries Dr. Sophia Yang – Chief Operating Officer
By e-mail only: sophia.yang@medipostamerica.com

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