Director of Clinical Applications Job at Robert Half (Albuquerque)

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

Director, Clinical Pharmacology

We are seeking a motivated Director, Clinical Pharmacology, to join our growing ...

Location

United States

Salary:

230000.00 - 260000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

PhD or PharmD with relevant expertise in clinical pharmacology or pharmaceutical science
5+ years of direct industry experience in conducting clinical stage drug development
Experienced in developing clinical pharmacology plans and authoring relevant sections of clinical and regulatory documents
Knowledge and experience in the application of current practices in the areas of clinical pharmacology, pharmacokinetic and pharmacodynamic principles, drug metabolism, bioanalysis, biopharmaceutics
Fluency in model-informed drug development
Experience working with external CROs
Proficient in using common PK/PD modeling software (such as Phoenix WinNonlin, Prism, and other similar tools)
Ability to work proactively and effectively, with exceptional creative problem-solving skills and self-motivation
Ability to work in cross-functional teams within a highly dynamic environment
Strong project management skills with a high sense of urgency, ability to collaborate and influence effectively cross-functionally

Job Responsibility

Lead clinical pharmacology programs in immunology & inflammation, providing strategic planning for drug development activities
Influence, decide, and recommend key clinical pharmacology strategies across the drug development spectrum
Develop and help implement quantitative approaches to drug development programs
Work in close collaboration with different functions
Lead and present key Clinical Pharmacology information to teams, senior leaders, regulatory agencies, and external partners
Independently lead Clinical Pharmacology/PK/PD activities and provide scientific and strategic expertise
Support pediatric development, including protocol development and dose selection
Develop and oversee implementation of clinical pharmacology studies from protocol development to final study reporting
Lead the analysis, interpretation, and reporting of clinical PK/PD data, author clinical study reports
Develop and execute and/or oversee PK/PD modeling strategies to describe the relationship between drug exposure and response

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

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

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

Director, Clinical Applications

The Director, Clinical Applications will plan, direct, and oversee all aspects o...

Location

United States , Denver

Salary:

136400.00 - 177400.00 USD / Year

InnovAge

Expiration Date

Until further notice

Requirements

Bachelor's degree in computer science, health informatics, or related technical field
10+ years of progressive leadership experience in healthcare technology organizations, with direct accountability for clinical application portfolios and functional team management
Deep knowledge and experience in a multi-disciplinary approach to healthcare technology, with specific experience managing clinical application ecosystems in PACE, senior care, or complex care coordination environments
Proven ability to lead and build strong, scalable, and diverse teams
demonstrated success leading geographically dispersed teams across clinical, technical, and operational disciplines
Healthcare experience is required, with hands-on knowledge of Epic EHR (including configuration, optimization, and FHIR API/interoperability capabilities), and familiarity with complementary clinical systems
Experience with Agile methodology and iterative delivery in regulated healthcare environments
Demonstrated experience hiring, managing, developing, and retaining highly technical staff and leadership in competitive healthcare IT markets
Demonstrated experience leading complex technology development and regulatory compliance projects on time and within budget, including EHR implementations, interoperability initiatives, and security hardening programs
Demonstrated experience leading operations and support teams, ensuring service levels are defined, met, and auditable for regulatory purposes (HIPAA, SOX)

Job Responsibility

Develops, procures, and deploys clinical technology solutions from concept through build/configure, integration, testing, and production deployment, including AI-enabled clinical tools and interoperability capabilities aligned with recognized standards
Operate, maintain, and support clinical technology solutions to meet service-level commitments, including Epic EHR, telehealth, in home services, and dental platforms
Balance demand management for multiple complex simultaneous projects, operational enhancements, regulatory compliance initiatives, break-fix, and maintenance requests
Partner with clinical, operational, and compliance teams to optimize workflows and design technology solutions that deliver value, exceptional user experience, and excellent outcomes for PACE participants and their caregivers
Research, recommend, and develop workflow solutions—including agentic AI, clinical decision support, and predictive analytics—to streamline processes, improve care quality, reduce costs, and enhance user experience
Collaborate with business stakeholders to create multi-year capability roadmaps that incorporate regulatory milestones (HIPAA Security Rule enforcement, CMS interoperability deadlines), grooming backlogs quarterly to create release packages/dates
Ensure all projects, initiatives, and processes conform to organizational policies, regulatory requirements (HIPAA, SOX), and are on schedule and within budget
Lead, mentor and develop the performance of the applications team
Collaborate across all IT functions to deliver sustainable, resilient platforms and applications, including the Cloud/Infrastructure, Integration, Architecture, and Data teams
Responsible for release and change management, coordination, and adherence to quality standards for multiple clinical technology solutions

What we offer

medical/dental/vision insurance
short and long-term disability
life insurance and AD&D
supplemental life insurance
flexible spending accounts
401(k) savings
paid time off
company-paid holidays

Fulltime

Behavior Specialist

The Behavior Specialist is responsible for conducting Cognitive Behavioral Thera...

Location

United States , Madison

Salary:

Not provided

Rogers Behavioral Health

Expiration Date

Until further notice

Requirements

Bachelor’s Degree (human services, psychology, social work, or related field preferred)
Relevant Cognitive-Behavioral Treatment (CBT) experience (12 months preferred). Relevant experience may include clinical care, human services, or educational equivalent
Complete Cognitive Behavior Therapy (CBT) or Dialectical Behavior Therapy (DBT) Academy as directed by operations manager under the consultation of the clinical supervisor or director within ninety (90) days of hire/transfer
A SAC-IT, SAC, or CSAC required in WI. A substance abuse specialty authorization applicable to the state hired in is required
Excellent written and verbal communication skills
Formal self-defense training is required with sixty (60) days of the date of hire/transfer. Annual re-certification is required
Compliance with Residential Care Center (RCC) and Community Based Residential Facility (CBRF) employee requirements
If business need should dictate, this role may be required to complete required medication pass training and pass medications in a residential setting

Job Responsibility

Attend and participate in CBT Academy and other training under the direction of the Clinical Services Manager or Director prior to working with patients. Time and training to be determined by the Clinical Services Manager or Director
Provide cognitive behavioral and other therapeutic services, except medication administration, to patients, according to clinical standards of care and under the supervision of the Clinical Services Manager or Director
Participate in weekly supervision sessions with the Clinical Services Manager or Director and communicate with the Clinical Services Manager or Director on an ongoing basis regarding clinical issues
Assure documentation of therapeutic treatment plans, outcome assessments, psychosocial information, and other patient care data is completed within the medical record
Participate in multidisciplinary treatment team meetings and complete treatment plan development
Offer training support to other staff members less familiar with the cognitive behavioral treatment of anxiety, mood, eating, and trauma-related disorders
Document mental health services according to applicable regulations and payer expectations
Communicate with Utilization Review department to provide information necessary to assist in facilitating payment for services
Perform other duties as assigned
Promote department goals and the mission of the Hospital

What we offer

Health, dental, and vision insurance coverage for you and your family
401(k) retirement plan
Employee share program
Life/disability insurance
Flex spending accounts
Tuition reimbursement
Health and wellness program
Employee assistance program (EAP)

Parttime

Clinic Supervisor

As a Clinic Supervisor, you'll share our vision for improving and expanding acce...

Location

United States

Salary:

Not provided

Ellie Mental Health

Expiration Date

Until further notice

Requirements

Master’s Degree or higher education in mental health discipline
Active and unrestricted license issued by a North Carolina Professional board (e.g., LCMHC LSCW, LMFT)
Strong leadership and problem-solving skill sets
Strong working knowledge of state requirements regulating mental health practice
Excellent verbal and written communication skills
Excellent interpersonal and customer service skills
Excellent organizational skills and attention to detail
Working understanding of human resource principles, practices, and procedures
Excellent time management skills with a proven ability to meet deadlines
Ability to function well in a high-paced and changing environment

Job Responsibility

Participate in leadership meetings when requested
Maintain billable hours expectations
Triage clinic staff’s administrative questions and concerns by connecting them to appropriate tools and resources
Troubleshoot issues within Valant, ADP, Teams, Outlook, and billing
Review EHR service lines and complete error corrections as needed
Collaborate with clinic director to support clinic in positive culture building (celebrations, anniversaries, community drives, etc.)
Monitor clinic capacity and practice patterns in support of the clinic director in hiring to meet FTE staffing requirements (office space and client waitlist)
Partner with clinic director to support administrative changes as needed (office space and waitlist)
Coordinate with clinic director to support the hiring process
this includes screening, interviewing, and onboarding processes

What we offer

401(k)
Dental insurance
Health insurance
Paid time off
Vision insurance
Flexible work from home options available
Reimbursement for CEUs

Fulltime

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Director of Clinical Applications

Job Description

Job Responsibility

Requirements

What we offer

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