Head of Clinical Development

It takes a team to reach the goal.

Join us to build a future in which patients suffering from fibrotic disorders have the hope to live longer and with an improved quality of life.

Remedy Cell, a biopharmaceutical company entering clinical stage focused on the discovery and development of cell-derived, cell-free, breakthrough therapies in complex fibrotic diseases opens a position for an experienced Head of Clinical Development.

The Head of Clinical Development role involves high level strategic planning and execution as well as hands-on responsibilities to support the growing clinical/clinical support activities. This role will manage and lead clinical development and related operations which includes clinical protocol development, regulation, study execution, and completion of study reports.

JOB RESPONSIBILITIES:

·    Supervise strategic clinical development plans and oversee protocol design, execution,

and data analysis/interpretation, with all relevant interfaces.

·   lead a clinical development and operations team to execute and achieve program goals

in compliance with global regulatory requirements.

·   Interface with global regulatory authorities, as appropriate, in support of the clinical

development objectives; promote the completion and approval of study-related

documents for regulatory authorities, ethics committees, and other related study

documents.

·   Establish and foster relationship and professional contacts with KOL’s, investigators,

partners consultants and vendors

·   Direct study design, protocol development, and execution of clinical studies.

·   Contribute to the overall clinical strategy of the ongoing clinical development programs

and product pipeline as well as giving in-depth clinical development advice on

potential new projects (internal and external).

·  Generate/review clinical components of key documents in support of regulatory

submissions,

·   Ensure quality of all clinical documents (e.g., Investigators’ Brochure, protocols, study

reports, clinical components of regulatory submissions, safety related documents).

·   Provide scientific clinical input to study-related documents and analysis plans including

Informed Consent Forms (ICF), Clinical Research Forms (CRF), Statistical Analysis Plans

(SAP), Clinical Pharmacology Analysis Plans (CPAP), and Clinical Study Reports (CSR).

·   Analyze and interpret clinical data expertly, and clearly communicate and interpretate

results both internally and externally.

·   Act as primary Medical Monitor, monitoring the safety of enrolled subjects on assigned

trials.

·   Ensure patient safety

REQUIRED SKILLS & QUALIFICATIONS:

·   PhD degree in the biological sciences; MD is a significant advantage.

·   7+ years of clinical development experience in a biopharmaceutical company leading

early and late-stage clinical trials.

·   Knowledge and understanding of early and late phase clinical trial design and global

regulatory requirements for study execution.

·   Experience with GCP/ICH/FDA requirements, clinical trial strategies, interpretation of

clinical data and generation of supporting regulatory submissions of clinical study

documents.

·   Clinical development experience within the field of advanced therapies, cell therapies or

biologics is strongly preferred.

·   Excellent communication skills and the ability to initiate and maintain relationships with

key opinion and thought leaders.

·   Experience managing physicians and/or scientific advisors in a management or team

leader capacity highly desirable.

· Exceptional interpersonal, influencing, presentation, and written and verbal

communication skills.

·   Trustworthy with highest integrity; committed to ethics and scientific standards.

·   Self-responsibility, commitment, and readiness for hard working

·   Ability to prioritize, respond to directives, and work in a fast-paced and changing

environment.

Individuals who want to submit their resume are welcome to send it to [email protected]