About Us: ASC Therapeutics is an independent, fully incorporated biopharmaceutical company with dedicated scientists and industry veterans with a strong belief in gene and cell therapy, the future for treating rare disease. We provide dynamic and people-oriented work environment, where you can learn about cutting-edge technology in gene therapy. Your contributions will also be greatly recognized by the company.

Job Title: Associate Director / Director – Head of Clinical Operations

Location: Milpitas, CA

Expected hours of work: 40

Reports to: Chief Medical Officer

Supervisory responsibilities:

Clinical Project Manager

Department interactions:

CEO, VPs and Directors

Regulatory Affairs

CMC

R&D

QA

Facility/operational manager

IT

Ordering and inventory management

Job Objective

This position is responsible for setting up and managing company’s clinical studies and support related regulatory submissions. The immediate goal is aligned with the company’s goal to conduct a Phase I/II clinical trial of 2nd Generation gene therapy in patients with hemophilia A. In parallel, to conduct a Phase IIb clinical trial of an Allogeneic Cell Therapy in patients with Graft-vs-Host-Disease in hematologic malignancies. More details available at www.asctherapeutics.com.

Job Summary

Manages study operational plans and CRO activities to ensure coordinated execution and quality of study deliverables.
Works closely with Regulatory Affairs and CRO to identify PIs in the US and ex-US to drives site identification and patient enrollment
Develops and implements strategic approaches to site engagement and patient enrollment
Contributes to relevant study documentation including clinical protocols, clinical study reports as well as operational plans
Leads the process of identifying potential vendors, reviewing proposals contributing to the selection process
Accurately tracks and reports study metrics to study team
Develops and reviews study related budgets and contracts
Responsible for approving invoices and overseeing study budgets
Works closely with internal groups and external collaborators, consultants and key opinion leaders to ensure that clinical studies are performed in a quality, timely and scientific manner.
In collaboration with the VP of Global Regulatory Affairs, supports regulatory submissions of pre-INDs, INDs, CTAs, BLAs, MAAs, to the FDA, EMA, and other agencies.
Proactively identifies project risks and resolves with some supervision
Establishes and maintains a working environment which fosters open communication, collaboration, integration, and teamwork
Participates in clinical operations initiatives and meetings as assigned and other duties as required
Assists in the preparation of training materials and presentations related to the planning and conduct of the trial
80% Clinical trials management and 20% Coordinating and managing regulatory submissions

Minimal Requirements

· MSc in related biology/medical field

· Clinical Research Associate and Good Clinical Practice certifications

· Minimum 5 years hands on experience in conducting clinical trials.

· Experience in CRO selection and management, including drafting request for proposals (RFPs), bidding process, etc.

· Knowledge of FDA regulatory requirements and medical practice/techniques and terminology.

· Excellent scientific writing skills.

· Good people and project management skills with high-powered drive and execution.

· Team building. Solution-focused problem solver. Excellent communication and interpersonal skills

· Ability to organize and prioritize multiple tasks.

· Ability to work within a team, including leadership skills.

· Attention to detail, organization, and problem-solving skills.

Preferred Backgrounds

PhD in related biology/medical field

· Experience in managing international multi-site clinical trials.

· Experience in communication with FDA, EMA and other regulatory agencies.

· Experience in gene therapy and hemophilia.

Contact: please send your resume to rola.wei@asctherapeutics.com

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