Clinical Chief Medical Officer/Clinical Operations Head (Boston)Qilu Pharmaceuticals • Boston, MA, United States
No longer accepting applications
Clinical Chief Medical Officer / Clinical Operations Head (Boston)
Qilu Pharmaceuticals • Boston, MA, United States
15 days ago
Job type
- Full-time
Job descriptionHold a Doctor of Medicine (MD) or PhD in pharmaceutical sciences or related fields. Candidates with a U.S. medical license or relevant professional certifications are preferred. Familiarity with the U.S. clinical research system and industry regulations is essential. Possess over 15 years of relevant work experience in U.S. pharmaceutical companies or clinical research organizations, including at least 5 years of experience in overseas clinical project management and strategy formulation. Track record of successfully leading innovative drug projects through FDA registration and approval to market launch is required. In-depth understanding of FDA drug registration and approval processes, regulatory requirements, and guidelines. Ability to independently lead communications with the FDA and effectively address regulatory inquiries and review comments. Exceptional cross-departmental and cross-organizational collaboration capabilities. Proven ability to coordinate resources across research sites, CROs / CSOs, expert teams, and internal departments to efficiently resolve complex issues in clinical project advancement. Strong industry acumen and risk management skills. Ability to adjust clinical strategies based on market dynamics and regulatory changes to ensure project quality, progress, and cost are well-controlled. Excellent verbal and written communication and presentation skills in both English and Chinese are required. Demonstrated leadership and team management experience. Ability to build and lead overseas clinical teams, drive the professional development of team members, and foster a highly collaborative work environment.
Job Responsibilities :
- Take overall ownership of formulating comprehensive strategies for Qilu Pharmaceutical's overseas clinical projects, including clinical development pathway planning, trial design optimization, and risk control. Ensure projects meet U.S. market demands and industry standards.
- Provide end-to-end medical support covering the entire lifecycle of overseas clinical research. Guide the implementation of clinical protocols, data interpretation, and resolution of medical inquiries to guarantee the scientific rigor and compliance of trials.
- Lead engagement with the FDA and relevant U.S. regulatory authorities. Oversee the overall compilation, submission, and follow-up of clinical registration dossiers to drive the regulatory approval process forward.
- Establish and maintain collaborative relationships related to overseas clinical research, including partnerships with research sites, CROs / CSOs, and industry experts. Coordinate and resolve cross-departmental / cross-organizational issues during project progression.
- Monitor the progress, quality, and cost of overseas clinical projects. Conduct regular project reviews, adjust strategies promptly in response to market changes or regulatory requirements, and ensure projects achieve their intended objectives.
Requirements :
Create a job alert for this search
Chief Medical • Boston, MA, United States
Related jobs
Reporting to the Medical Director of Primary Care (MDPC), the Director of Clinical Education provides leadership and oversight for medical education and clinical training programs across Fenway Hea...Show more
Executive Director, Clinical Operations.Be among the first 25 applicants.Executive Director, Clinical Operations.By clicking the “Apply” button, I understand that my employment application process ...Show more
A leading CRO specializing in oncology is seeking a Senior Director of Clinical Operations in Boston.The candidate will oversee oncology-focused clinical trials, ensuring compliance with regulatory...Show more)
Chief of Urology - BMC Brighton.Be among the first 25 applicants.Chief of Urology - BMC Brighton.Get AI-powered advice on this job and more exclusive features.
Boston Medical Center – Brighton.Bosto...Show more
To support its thriving clinical service, the Department of Pathology and Laboratory Medicine is seeking a full-time .The Department of Pathology is accredited by both the College of American ...Show more
The Manager, Clinical Operations is responsible for the execution of study-level activities including but not limited to creating and updating trial-specific documents, vendor oversight & delivery,...Show more
Take overall ownership of formulating comprehensive strategies for Qilu Pharmaceutical's overseas clinical projects, including clinical development pathway planning, trial design optimization, and ...Show more Head of Medical Affairs, Oncology Business Unit.The Head of Medical Affairs, Oncology Business Unit (OBU) will provide and drive near and long‑term strategic direction, as well as development and o...Show more 
Chief Technology Officer Application Deadline : .Boston Health AI- A C10 Cohort Company.Description About Boston Health AI.
Boston Health AI is redefining clinical care through next-generation, physic...Show more
Lead the formulation and execution of clinical development plans and trial protocols based on scientific principles, regulatory guidelines, market positioning, expert advice, patient rights, and th...Show more
Boston Medical Center - Brighton.Department of Surgery, Division of Urology at Boston Medical Center - Brighton.Boston Medical Center Health System, is seeking a full- time Board-Certified fellowsh...Show more
Senior Clinical Research Director.Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research.
In R&D, you’ll drive breakthroughs that could turn the impossible in...Show more![Vice President, Market Chief Medical Officer(Preferred Experience in Behavioral Health & Manage[...]](https://cdn-logos.talent.com/v1/logo/image?feedcode=clickcast-jobtraffic&company_name=CareSource)
The Vice President, Market Chief Medical Officer has accountability for ensuring that local health plan, CareSource initiatives focusing on clinical excellence, quality improvement, appropriate inp...Show more
The Vice President, Market Chief Medical Officer has accountability for ensuring that local health plan, CareSource initiatives focusing on clinical excellence, quality improvement, appropriate inp...Show more
The Global Program Clinical Head (GPCH) is the global clinical leader responsible for one or more clinical programs across indications, involving one or multiple compounds.As the leader of Global ...Show more
Senior Vice President, Head of Clinical Development.AVEO Oncology is seeking a highly skilled and experienced Medical Director to join our dynamic team.
The successful candidate will have a strong b...Show more
Head of US OBU Medical Affairs.By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application wil...Show more
Senior Vice President, Head of Clinical Development.AVEO Oncology is seeking a highly skilled and experienced Medical Director to join our dynamic team.
The successful candidate will have a strong b...Show more
Director of Clinical Education
Fenway Health • Boston, MA, United States
Full-time
Last updated: 26 days ago • Promoted
Executive Director, Clinical Operations
BioSpace • Boston, MA, United States
Full-time
Last updated: 30+ days ago • Promoted
Oncology Clinical Operations Leader
Progensearch • Boston, MA, United States
Full-time
Last updated: 3 days ago • Promoted
Chief of Urology - BMC Brighton
Boston Medical Center (BMC) • Boston, MA, United States
Full-time
Last updated: 30+ days ago • Promoted
Chief of Clinical Pathology - Tufts Medical Center, Boston, MA
Tufts Medicine • Boston, US
Full-time
Last updated: 30+ days ago • Promoted
Manager, Clinical Operations
Alnylam Pharmaceuticals • Cambridge, MA, United States
Full-time
Last updated: 30+ days ago • Promoted
Clinical Chief Medical Officer
Qilu Pharmaceutical • Boston, MA, United States
Full-time
Last updated: 5 days ago • Promoted
Head of US OBU Medical Affairs
BioSpace • Boston, MA, United States
Full-time
Last updated: 2 hours ago • Promoted • New!
Chief Technology Officer
C10labs • Boston, Massachusetts, United States
Full-time
Last updated: 21 hours ago • Promoted • New!
Clinical Chief Medical Officer
Association of Clinicians for the Underserved • Boston, MA, United States
Full-time
Last updated: 1 day ago • Promoted
Chief of Urology - BMC Brighton
Boston Medical Center • Brighton, MA, United States
Full-time
Last updated: 30+ days ago • Promoted
Senior Clinical Research Director, Ophthalmology
Sanofi • CAMBRIDGE, MA, US
Full-time
Last updated: 7 days ago • Promoted
Vice President, Market Chief Medical Officer(Preferred Experience in Behavioral Health & Manage[...]
CareSource • Boston, MA, United States
Full-time
Last updated: 15 days ago • Promoted
Vice President, Market Chief Medical Officer(Preferred Experience in Behavioral Health & Managed Care)
CareSource • Boston, MA, United States
Full-time
Last updated: 30+ days ago • Promoted
Global Program Clinical Head
Novartis Group Companies • Cambridge, MA, United States
Full-time
Last updated: 30+ days ago • Promoted
Medical Director
AVEO Pharmaceuticals • Boston, MA, United States
Full-time
Last updated: 30+ days ago • Promoted
Head of US OBU Medical Affairs
Takeda • Boston, MA, United States
Full-time
Last updated: 14 days ago • Promoted
Medical Director
Page Mechanical Group, Inc. • Boston, MA, United States
Full-time
Last updated: 30+ days ago • Promoted