Medical Director Or Clinical Research Director Jobs

Approximately 240 FTEs (including 7 Managers for Surgical Services, Sterile Processing & Endoscopy + 2 Assistants)

Previous Director experience running a large OR with multiple service lines including CV, Neuro, Orthopedics, General Surgery, Oncology, etc.

24 Operating Rooms servicing all major service lines, 4 Xi Robots a Hybrid Room and a separate 4 Room Endoscopy Unit

Part of an established Level II Trauma Medical Center

Strong knowledge of cross-functional project management and company systems

Ensures appropriate project management resourcing strategy in place to meet corporate and project objectives for new and ongoing projects.

Oversees and ensures maximum performance of project team’s planning, execution and risk management.

15 years of relevant experience

Experience with RFP's and leading bid defense meetings

Experience managing a portfolio in terms of budgets & studies.

Leads and develops contracts, Invoices, and Finances related to procedures and protocols for Global team for 7-10 projects.

Monitors and oversees study requirements are conducted, including ensuring the study inclusion/exclusion factors, products, time points, and panelists are included.

Advanced Clinical/Science degree or professional credentials required (BS, MS, PhD, PharmD, and/or scientific background/experience)

Rele ant transferable experience (clinical practice, clinical or scientific training, academic research, and regulatory/scientific).

Experience in Medical/Cosmetic Dermatology, Plastic Surgery, Cellular Biology, and/or Facial Aesthetic disciplines strongly desired.

Strong analytical skills and presentation skills

10-12+ years of experience including management of GCP Quality in a pharmaceutical or biotech environment in progressively responsible Quality roles required

Develop metrics to support GCP activities and quality management review

Lead, manage, develop, and mentor direct report(s)

Experience with transition from Phase 1-3 to commercial quality systems is a plus.

Previous experience working with FDA and participating in regulatory agency inspections of clinical research activities

Excellent interpersonal and influencing skills

Work with Admissions marketing and the Batten Scholars program to help recruit applicants who have tech sector experience, interests, or aspirations

Apply skills to solve most problems without review, and latitude to devise the approach and method to performing initiatives

Director - Master’s Degree with at least seven years of relevant experience. Experience in the technology sector strongly preferred.

Demonstrated results for achieving metrics-driven goals through systemic development with educational or similar organizations.

Excellent communication skills, especially written.

Primary stakeholders and related responsibilities include:

Must maintain documentation of ongoing continuing medical education to satisfy the requirements of managed care agencies.

Participate on at least one the agency’s standing committees: Continuous Quality Improvement, Continuing Education, Health & Safety, or Compliance.

Three (3) years’ experience in adult primary care preferred.

Must possess and maintain board certification in Internal Medicine, Family Practice, or Addiction Medicine.

Must maintain current certification in basic life support and as an HIV primary care provider.

Knowledge of computer systems and software pertaining to EMR and related systems.

Represent the project in relevant teams and the protocol review committee and review and comment the Investigator’s brochure.

Balancing the duties of a physician with that of an administrator.

Ensuring that patients receive the highest standard of medical care.

Being responsible for the performance of physicians under your supervision.

Ensuring that all healthcare regulations and safety standards are met.

Keeping staff updated on new healthcare regulations.

Working knowledge of GCP/ICH, clinical trial design, clinical development processes, and regulatory requirements.

MD (or ex-US equivalent) or MD-PhD degree required. Advanced degree or research experience in immunology preferred.

Specialty training in rheumatology and/or industry experience in clinical development of therapeutics in autoimmune diseases.

Reporting to the Chief Medical Officer

Support, as the clinical representative, the transition of preclinical projects to clinical development.

As the clinical trial study physician, be responsible for clinical deliverables and activities, including:

Minimum of ten years of experience in governmental, regulatory, rate or operations management.

Minimum of five years direct people management experience.

Project management skills; ability to prioritize and handle multiple issues and projects concurrently.

Manage and make recommendations regarding the preparation of revenue requirement, cost of service and regulated pricing analyses.

Manage and make recommendations regarding the execution of regulatory strategy for general rate cases and other regulatory initiatives.

Provide knowledgeable and credible technical expertise related to industry issues in regulatory and other forums.

Strong leadership and management skills, including the ability to motivate

Excellent computer skills including extensive knowledge of MS Word, Outlook, Excel, PowerPoint, Teams.

Promote the clinical research environment, technical skills, and strategies to optimize clinical trial operations for ALS clinical trials.

Highly effective verbal and written communications skills.

Strong organizational skills, detail-oriented, and efficient.

Demonstrated experience in program development and oversight.

Utilization management, quality and / or management experience, is strongly preferred.

EDUCATION and EXPERIENCE: (Minimum educational qualifications)

Have an understanding of principles of utilization management and quality assurance.

Assist with regulatory requirements including external and internal audits and monitoring

Minimum of five years of clinical experience is required.

Be an effective team player, with excellent interpersonal, cross-departmental and leadership skills.

Gene therapy and knowledge of neuroscience biomarkers are a plus.

MD (Neurology) required, with clinical or research experience in neuroscience.

3+ years of experience with gene therapy focused clinical development programs in the pharmaceutical industry.

Ability to think critically and demonstrate troubleshooting and problem-solving skills.

Demonstrated leadership and team building skills as well as the ability to perform effectively in a multi-disciplinary environment.

Ability to lead directly and by influence, including strong interpersonal, problem solving, conflict resolution and analytical skills in a matrix environment.

Preparing operational summaries to include resource management, forecasting, and capital equipment needs.

Experience in a people leadership role with strong skills in hiring, coaching, and developing team members.

Board certification by the American College of Laboratory Animal Medicine (ACLAM).

8+ years of relevant experience in a government, industry, or academic setting.

Experience in the applications of animal models to drug discovery including non-clinical animal studies, and generation and submission of IND applications.

Strong experience managing in vivo facilities in an industry setting.

Minimum of 2-3 years of direct people management experience, including a remote workforce, required

Excellent presentation and facilitation skills to large groups including senior management

Frequently interacts with internal and external management and senior-level customer representatives concerning projects, operational decisions, scheduling requirements, and/or contractual clarifications

Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization

Lead and develop consistent manager processes for the BU in partnership with leadership

Manage all payment related activities for Clinical and Medical Affairs