Director Clinic Operations Job at American Nursing Care (Kearney)

Senior Medical Director, Clinical Development

Cabaletta is seeking an experienced, highly motivated hands-on physician leader ...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

D., M.D./Ph.D. degree or equivalent required
Board Certification, Board Eligibility, or clinical experience in the field of Rheumatology and/or Immunology highly desirable
7+ years of experience in clinical research, including the design and execution of complex clinical trials, with a pharmaceutical or biotech company
Experience with or exposure to the development of adoptive cell therapies or biologic therapies is desirable
Experience with Health Authority interactions and submission of clinical regulatory documents is desirable
Strong written and verbal communication skills
ability to easily engage with investigators and key external experts
and ability to effectively present at conferences, advisory meetings, and other public for a
Engaged, hands-on, independent, and goal-oriented mentality
willingness to work in highly dynamic work environment

Job Responsibility

Provide medical leadership for various programs from first-in-human studies through registrational studies
Formulate study designs, lead protocol development, partner with internal cross-functional teams in study start-up activities, and collaborate with clinical investigators, key external experts, and Health Authorities
Participate in direct, hands-on involvement in all aspects of study conduct clinical activities, working with clinical operations, including data review, analysis, and reporting that conform to the ethical, safety, and quality standards of Cabaletta, GCP, and Health Authorities
Become an expert and remain current in the relevant therapeutic areas and in the field of cell and gene therapy through review of the scientific literature, interactions with key external experts, and attendance at relevant scientific meetings
Actively contribute during Health Authority interactions
Review available preclinical data that could inform the design of future clinical trials
Present at site evaluation and site initiation visits as applicable
In partnership with relevant cross-functional team members, actively engage in the preparation of Clinical Study Reports, Annual Reports and other safety reports, Health Authority pre-meeting packages, Investigator Brochures, periodic clinical reports, and BLA submission documents
Collaborating with cross-functional groups, formulate publication strategy including active participation in authoring, preparation and review of manuscripts, conference abstracts and presentations and other external presentations of clinical data

What we offer

health and retirement, PTO, and stock option plans

Medical Director, Clinical Development

We are seeking an experienced, highly motivated Medical Director, Clinical Devel...

Location

United States , Waltham; San Diego

Salary:

205000.00 - 250000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

2+ years of industry experience in clinical development, preferably in a biotech or small pharma environment
Hands-on experience designing and executing clinical trials
Experience with IND submissions and global regulatory filings
Understanding of GCP, clinical trial design, regulatory requirements, and safety monitoring
Excellent written and verbal communication skills, including protocol and regulatory document writing
Demonstrated ability to engage with KOLs, investigators, and cross-functional teams
Can work independently
self-starter attitude
MD or equivalent is required

Job Responsibility

Responsible for medical monitoring/reporting and safety activities
Provide medical leadership in the design, planning, and execution of clinical development strategies across multiple studies
Acts as the medical contact at the company for clinical/medical issues
Interprets, reports, and prepares oral and written results of product research, in concert with senior clinical personnel
Serve as the medical expert for assigned assets studies
Contribute to regulatory interactions and strategy, including IND/CTA submissions and briefing packages
Collaborate and work closely with Clinical Operations to ensure appropriate site selection, patient recruitment strategies, and high-quality trial execution
Oversee and support data interpretation, analysis, and clinical study reports
Work closely with internal stakeholders, including Regulatory, Safety, CMC, and Translational Science teams
Partner with external collaborators, KOLs, CROs, and investigators

What we offer

Comprehensive health benefits and tax-advantaged savings accounts
Flexible time off, 13 paid holidays, and a companywide year-end shutdown
Monthly wellness stipend
Generous 401(k) match
Disability and life insurance

Fulltime

Medical Director, Clinical Development - Dermatology/Immunology

We are seeking a Medical Director to oversee clinical execution and medical moni...

Location

United States

Salary:

280000.00 - 325000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

MD is required
Experience in clinical development within the Immunology & Inflammation therapeutic areas, ideally dermatology, allergy or rheumatology
2+ years’ industry experience as a medical monitor and/or medical director
Experience working on phase 2 and 3 clinical studies required
Highly motivated team player with a growth mindset, can-do attitude and willing to learn from others
Effective communication skills with an ability to present to a variety of stakeholders and tailor message accordingly
Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
Ability to travel approximately 20% to All Team meetings, functional meetings, study-related activities, and medical conferences

Job Responsibility

Serve as a medical monitor, working closely with the CRO, clinical operations, and pharmacovigilance on study execution including but not limited to safety reporting, point of escalation for medical monitoring matters, development and execution of the Medical Monitoring Plan
Support the design of trials and develop protocols and other relevant documents for individual studies
Support all the start-up activities related to the assigned dermatology clinical study
Oversee day-to-day clinical and medical execution of studies
Work closely with cross-functional colleagues, including, but not limited to, clinical operations, regulatory, biostatistics, and data management, to ensure timely and flawless execution of clinical plan
Partner with clinical operations on site selection, recruitment, and CRO management
Partner with medical affairs to build and maintain strong relationships with PIs, including support of Advisory and Scientific Boards
Serve as primary medical point of contact for sites and PIs for the assigned study, as applicable

What we offer

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

Fulltime

Campus Director, Clinical Education - Physician Assistant

The Campus Director of Clinical Education, Physician Assistant is a key member o...

Location

United States , Ontario

Salary:

138230.12 - 200406.07 USD / Year

American Career College

Expiration Date

Until further notice

Requirements

For PA and Physician Candidates: Minimum of three (3) years of teaching, research, or clinical experience in a PA program/Medical School, or equivalent*** experience in health professions education, healthcare delivery, or related fields that directly support PA student learning and curricular outcomes.
For Non-Clinician Scientist candidates: Minimum of one (1) year of full-time experience in PA education, academic support, or curriculum development in alignment with program needs.
Demonstrated the ability to develop clinical and didactic curriculum, program evaluation and student assessment.
Leadership knowledge in the program field to cultivate a learner-centered environment and to foster excellence.
Knowledge and evidence of strong supervisory and management skills as applicable to specialized program area.
Knowledge of state, federal and local laws/regulations relating to programs, governmental compliance and other regulatory standards such as Title IV, WSCUC, and ARC-PA and other accreditation standards.
Physician Assistant/Associate (PA) Candidates: Graduation from an ARC-PA accredited PA program.
Master’s degree in education or a related health- or social-science discipline.
Current National Commission on Certification of Physician Assistants (NCCPA) certification or eligibility* to sit for the PANCE (initial certification) or PANRE (recertification) at the time of hire.
State PA licensure or eligibility* for licensure in state of campus location.

Job Responsibility

Collaborate as a member of the programmatic leadership team, which may consist of the MPA Dean/Program Director, Medical Director, Director of Academic Education, and Director of Student Success to achieve a shared vision for the program.
Collaborate with the MPA Dean/Program Director, Medical Director, and the WCU Clinical Operations team to develop, evaluate, and maintain clinical sites and preceptors sufficient in number and quality to meet ARC-PA Standards.
Communicate with MPA Dean/Program Director ongoing new site development and needed support to facilitate Program/Preceptor relationships, including support from the Medical Director.
Contacts, develops new and maintains established clinical affiliations, assuring all clinical sites meet the program’s prescribed learning outcomes, and securing appropriate contact and specific contractual agreement information including identified preceptors, number and types of placements, renewals, insurance and liability matters, and other pertinent issues important to seamless transition of students to clinical sites.
Prepares and submits to MPA Dean/Program Director annual program clinical calendar, individual student clinical placement schedule, and oversees preparation and formal distribution of student clinical placement assignments with detailed site, setting, and discipline-related information on timeline set by MPA Dean/Program Director.
Provide leadership, oversight, and performance evaluation for the clinical phase team, as assigned.
Develops, maintains, and conducts a schedule for clinical site visitation and presents a written copy to the MPA Dean/Program Director at a specified time each year with updated list of new and renewed affiliation agreements.
Develops, implements, stores, and updates as needed Clinical Site Visit Forms to ensure rapid retrieval and MPA Dean/Program Director and faculty access to documented site visits and/or phone calls.
Conduct clinical site visits and monitor student performance in Supervised Clinical Practice Experiences (SCPEs).
Lead the design, development, implementation, coordination and ongoing evaluation of an innovative clinical curriculum to ensure alignment with ARC-PA Standards, PAEA’s End-of-Rotation Exams, the NCCPA blueprint, and degree requirements.

What we offer

medical
dental
vision
flexible spending accounts
401(k) match
paid time off
holidays
parental leave
tuition reimbursement
adoption assistance

Fulltime

Hospice Director Clinical Services

JourneyCare Hospice is seeking a Hospice Director of Clinical Services to join o...

Location

United States , Barrington

Salary:

100000.00 - 120000.00 USD / Year

Arcadia Home Care and Staffing - an Addus family company

Expiration Date

Until further notice

Requirements

Graduate from an accredited registered nursing program
One year hospice experience required
Two years healthcare management experience required
Must have good knowledge of hospice Medicare, Medicaid, State and Federal guidelines
Maintains a current CPR certification
Must be a licensed driver with an automobile that is insured in accordance with state and/or organization requirements and is in good working order

Job Responsibility

Ensures that care is provided in accordance with Medicare, Medicaid, Federal and state guidelines
Ensures that all direct care clinical staff are assigned appropriately
Monitors business operations to insure financial stability
Monitors operational progress toward accomplishing operational and strategic goals
Establishes and maintains effective, open channels of communication
Ensures adequate and appropriate staffing and staff supervision
Ensures complete, appropriate, and adequate staff development, including orientation, in-service, continuing education, competency testing and quality assessment performance improvement
Responsible for the management of the hospice program in matters of clinical operation
Demonstrates exceptional service to patients, families, referral sources, co-workers, and other customers
Active participant in receiving case referrals

What we offer

Great culture and team atmosphere
Comprehensive benefits, including medical, dental, and vision, effective on the first of the month
401(k) retirement plan with a generous company match
Generous time off accruals
Paid holidays
Mileage reimbursement
Tuition Reimbursement
Employee Referral Program
Bonus Eligible
Hospice Certification benefit and salary increase

Fulltime

Senior Director, Clinical and Regulatory Writing

The Senior Director, Clinical and Regulatory Writing will serve as a strategic l...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Advanced degree in life sciences (M.D., or PharmD preferred)
MS, PhD with significant clinical pharmacology writing experience will be considered
12+ years of progressive experience in regulatory or scientific/medical writing in the biopharmaceutical industry, including 5+ years in a leadership role
Demonstrated experience developing content for major global regulatory submissions (e.g., IND, BLA, MAA), preferably in cell or gene therapy
Strong understanding of drug development processes, regulatory frameworks (FDA, EMA, ICH), and clinical trial documentation requirements
Exceptional writing, editing, and analytical skills with the ability to convey complex scientific data clearly and persuasively
Proven leadership capabilities, including team development, cross-functional collaboration, and vendor management
Proficiency in Microsoft Office Suite, document management systems (e.g., Veeva Vault), and electronic publishing tools
Strong project management skills with the ability to prioritize competing demands in a fast-paced, deadline-driven environment
Collaborative mindset with the ability to influence and guide stakeholders across disciplines and levels of seniority

Job Responsibility

Lead the clinical writing function in the development, review, and approval of regulatory documents to support global submissions (e.g., INDs, IMPDs, BLAs, MAAs, Orphan Drug Applications, Investigator Brochures, protocols, clinical study documents, PSPS/POIPs, Prime, RMAT)
Lead cross-functional content planning of regulatory submission modules, including data integration and interpretation, and ensuring consistency in strategic messaging for dossiers, meeting packages and responses to health authorities
Translate complex technical data from clinical and biostatistics teams into scientifically accurate, submission-ready documentation
Manage external consultants and contractors as needed to support Cabaletta submissions reviews, authoring, if needed, and gap analyses
Mentor, train, and manage a team of medical/regulatory/technical writers or cross-functional contributors in document development
Develop and implement strategic plans for medical writing activities, aligning them with clinical development, regulatory affairs, and overall business goals
Drive process improvements and develop standard practices for efficient, compliant and high-quality document delivery
Collaborate with Clinical Operations and external CROs to ensure inspection readiness of clinical trial documentation, including informed consents, study manuals, and IRB/IBC responses

What we offer

health and retirement, PTO, and stock option plans

Regional Director, Supply Chain Operations

The Regional Director, Supply Chain Operations will be responsible for multiple ...

Location

United States , Brentwood, Tennessee

Salary:

Not provided

Ardent Health

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Business Management, Healthcare Administration, or Finance
3+ years of people management experience in an acute care hospital setting
5+ years of supply chain management experience
Multi-facility experience
Excellent verbal and written communication skills
Intermediate to advanced Microsoft Excel proficiency
Intermediate PowerBi proficiency is helpful
Demonstrated ability to work in a professional, multi-disciplinary team as a group leader, facilitator or participant
Demonstrates initiative, dependability and flexibility to work in a fast paced work environment
Sound business judgement with a strong understanding of healthcare services, operations & finance

Job Responsibility

Responsible for ensuring consistent operations of inventory management, transportation, and distribution
Lead and manage Supply Chain activities for all facilities within assigned region
Execute the infrastructure project plan for each facility
Facilitate the implementation of market-based purchasing projects at each facility
Coordinate, manage, and evaluate facility Supply Chain directors, managers, and supervisors
Coordinate and drive efforts to enable supply improvement initiatives to succeed within the region
Ability to pull, analyze, and interpret data, identify issues/opportunities and implement solutions regarding supply spend, utilization, and metrics
Facilitate the standardization of products and optimize supply utilization through effective collaboration with the Clinical Resource Director, physicians, and clinicians within the region
Manage the market implementation plan, identify and mitigate risks, and monitor resource allocations to ensure successful execution of plan
Execute the Supply Chain Performance Measurement plan in the region and report these results to the Supply Chain leaders

Fulltime

Associate Director, Regional Clinical Operations

Associate Director, Regional Clinical Operations. ICON plc is a world-leading he...

Location

United States , Atlanta; Houston; Tampa; Dallas

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Minimum Bachelor’s degree with 5-7 years of experience in Clinical Trial Operations in pharmaceutical / biotechnology industry or Clinical Research Organization, or equivalent, including at least 3 years in a role of primary responsibility for clinical trial execution and management
Thorough understanding and experience in global clinical trials in a diverse range of patient populations with preferred experience in both oncology and hematology
Direct management experience and supervisory responsibility
Demonstrated leadership and management skills
Goal oriented, self-starter with proven ability to work independently
Good knowledge and experience working with external specialist vendors
Excellent interpersonal, organizational, problem-solving, and written/verbal communication skills, confidence, and ability to work effectively with a wide variety of medical, research and administrative personnel
Able to proactively identify issues and provide potential solutions for resolution
Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines and to established quality standards
Proficient in Outlook/Word/Excel/PowerPoint

Job Responsibility

Accountable for oversight of all assigned studies within the country in accordance with the overall development plan and clinical operations plan and under the direction of the global team (Global Clinical Trial Manager), including adherence to quality, timelines and budget
Accountable for planning and executing assigned country study goals and commitments, and as needed, leading, organizing, and participating in regional and/or local meetings and training sessions to implement country-level recruitment plans
Develops, builds and maintains optimal relationships with key institutions within the country (i.e. Site Alliance Sites), working closely with the Medical Science Liaisons, Global Site Management and Central Services, and other departments as indicated according to the Site Engagement Strategy
Drive the identification and inclusion of sites that have access to and can enroll patients who are from groups that have been historically underrepresented in clinical trials (per FDA Guidance for Industry for Improving Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials)
Oversees regional study feasibility, site monitoring performance, quality metrics and all relevant activities for assigned studies
Drives evidence-based site recommendations and selection
Provides support and training for sites to support diverse recruitment and retention, review, assist and optimize site-level diversity plans as needed, check and challenge progress and coordinate and align central efforts across sponsor and CROs
Align local and central initiatives and advise and guide on effective community engagement activities
Conduct co-monitoring and site identification visits, as needed
Collaborates cross-functionally to build and maintain strong relationships and interaction at the country local level (i.e. Medical Science Liaisons, Medical Monitors, Clinical Scientists, etc.) that directly contribute to key study activities and milestones

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Fulltime

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Director Clinic Operations

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