Director Clinical Monitoring and Site Management (m/w/d)

POSITION SUMMARY: The Principal Faculty member, as a part-time faculty instructor within the Physician Assistant (PA) Program, is primarily responsible for course instruction and/or course coordination in the didactic and/or clinical phase of the program. This individual is expected to demonstrate effectiveness in course design, delivery, and evaluation, and plays an important role in supporting students to achieve the program’s student learning outcomes and the competencies required for PA practice.   Under the guidance of the program leadership, the part-time Principal Faculty member contributes to curriculum development, program assessment, and continuous quality improvement in accordance with the ARC-PA Accreditation Standards. This role includes active participation in program planning, academic support, and other activities that foster student and programmatic success. The part-time Principal Faculty member holds a faculty appointment (rank commensurate with experience) within the Physician Assistant Program.   The Principal Faculty member will serve as the primary instructor and course coordinator for the Medical Anatomy and Physiology lecture and laboratory series. This responsibility includes oversight of cadaver-based dissection and on-campus laboratories, where the faculty member will lead hands-on anatomical instruction in a collaborative, clinically integrated learning environment. The ideal candidate will possess advanced knowledge of human anatomy, physiology, and pathophysiology and demonstrate a commitment to fostering student engagement and mastery in foundational medical sciences. In addition to this core teaching responsibility, the faculty member will contribute to other didactic courses as assigned, supporting a comprehensive, systems-based curriculum aligned with the program’s learning outcomes and PA practice competencies.   The part-time faculty member works 20 hours a week with a teaching workload as assigned to meet the needs of the program annually as defined in the Faculty Supplement. In fulfilling the responsibilities of this role, the incumbent is expected to uphold and promote the philosophy of South University, which emphasizes quality services to students and stakeholders; development, engagement, and recognition of employees; sound economic and operational principles; and an environment that fosters innovation, positive thinking and institutional growth.   KEYJOB ELEMENTS: 1. Provides teaching and instruction in the PA Program as assigned based on program needs: * Coordination of instruction of courses as assigned based on program needs. * Teaching in areas of clinical and/or professional expertise. * Serving as a small group facilitator and student faculty advisor as needed. 2. Assists the Director of Didactic Education in the administrative coordination of the didactic phase of the program. 3. Assists the Director of Clinical Education in the administrative coordination of the clinical phase of the program. 4. Contributes to curriculum development, including the design and implementation of courses within the program. 5. Participates in ongoing curriculum evaluation and continuous quality improvement initiatives. 6. Evaluates student performance during objective structured clinical examinations (OSCEs), lab practicals, clinical reasoning sessions, problem-solving activities, and technical skills training and assessment during the didactic and clinical phases. 7. Reviews and evaluates student performance on submitted assignments, projects, and presentations ensuring use of quality evidence-based resources and citations. 8. Develops course examinations and maps exam questions to ARC-PA accreditation standards and the NCCPA Content Blueprint to ensure alignment with program learning outcomes. 9. Provides input to assist with accreditation efforts, program self-assessment, and periodic review of the program’s mission and goals. 10. Participates in the program's admissions process to include student recruitment, open houses, application review, candidate interviews, and student selection. 11. Engages in service, community and campus outreach, and scholarly activities appropriate to the role of a part-time Principal Faculty member. 12. Participates annually in faculty development opportunities focused on teaching effectiveness and staying current in medical knowledge. 13. Assists with clinical site development, monitoring, and relationship management as needed to support the clinical phase of the program. 14. Provides remedial instruction to support student academic success and progression through the program. 15. Assists with other responsibilities as determined by the Directors of Didactic and Clinical Education, Program Director, or campus leadership. 16. Performs duties as assigned and outlined in the Faculty job description and in accordance with the provisions of Faculty Supplement to the South University Employee Handbook. JOB REQUIREMENTS: * Terminal degree in healthcare disciplines such as physician assistant, pharmacy, medical doctor, or public health. Minimum of a Master’s degree is required. * Eligibility for professional licensure/certification in the applicable state and healthcare discipline (if applicable) or holds an active, valid, and unencumbered state license. * 1-2 years teaching experience in a graduate health-related profession highly preferred. * 2 years of clinical experience required, if applicable. * Experience in PA/medical classroom teaching preferred. * PAs must have graduated from an accredited PA program and have current or emeritus NCCPA certification. * Emeritus clinicians are not required to hold active licensure. * Excellent communication skills, both verbal and written.  * Strong interpersonal skills with student and staff populations. * Superior organization, prioritization, and self-motivation skills. * Strong computer skills, including MS Office Suite, ExamSoft, and WebAdMIT. * Ability to interact effectively as a member of a team and work collaboratively with other departments. * Ability to read, understand, interpret, and implement accreditation criteria and state agency regulations. * Ability to resolve inquiries and complaints from employees, students, regulatory agencies, or members of the academic or business community. * Ability to listen to customers (e.g. staff, students, etc.) and to understand and respond positively to their requests. * Ability to adapt to changing assignments and multiple priorities. * Ability to manage multiple tasks and successfully meet deadlines.   WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions. The term "qualified individual with a disability" means an individual with a disability who, with or without reasonable accommodation, can perform the essential functions of the position.    While performing the duties of this job, the employee is regularly required to communicate professionally in person, over the telephone, through email and other electronic means, move about the office or school, handle various types of media and equipment, and visually or otherwise identify, observe and assess. The employee is occasionally required to lift up to 10 pounds unless otherwise specified in the job description. The individual must be able to travel out of the local area with an occasional overnight stay to participate in a variety of conferences and meetings.   South University is an Equal Opportunity Employer and embraces diversity as a critical step in ensuring employee, student and graduate success. We are committed to building and developing a diverse environment where a variety of ideas, cultures and perspectives can thrive.

About Us  Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world. It is Kardigan’s mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve.   Led by Tassos Gianakakos, Jay Edelberg, M.D., Ph.D., and Bob McDowell, Ph.D., Kardigan’s co-founders have reunited after leading MyoKardia to discover and develop mavacamten, the first cardiac myosin inhibitor, resulting in an acquisition by Bristol Myers Squibb in 2020.   We have a cutting-edge discovery and translational research platform, a pipeline of late-stage candidates, and an industry-leading team that is driven to improve the lives of patients.   At Kardigan, we are motivated by our values which guide how we work, interact, and achieve our goals. Driven by patients and their families, we are deeply committed to improving the lives of patients and prioritizing their needs above all else. We believe in being authentic—leading with truth to bring out the best in others by creating an environment where every person knows they will be fully accepted. With an eagerness to learn, we encourage the highest levels of curiosity and are open to changing our minds. We are committed to winning as a team with urgency, excellence, and intention, and support each other no matter what role we play or where we sit. Lastly, we strive to enable the impossible because patients are counting on us. We are not afraid to take risks to unlock innovation and advance scientific discoveries.   These values are the foundation of our work, empowering us to make a real difference, every day.     Position Title:  Senior Director / Medical Director – Clinical Trial Lead   Department:  Clinical Development   Reports To:  Vice President, Clinical Development Lead  Location: South San Francisco, CA or Princeton, NJ – On-site 3-4 days per week       Job Overview   The Senior Director / Medical Director - Clinical Trial Lead will be a physician with extensive drug development expertise who will be expected to lead to the clinical development strategy for the phase 1-3 clinical trials of the program, including the protocol design, operational planning and trial execution, medical and safety monitoring, trial close out, trial results interpretation, and preparation for dissemination of the trial results, working with academic partners.      Essential Duties and Responsibilities   * Leads the aforementioned clinical activities for the phase 1-3 trials for the program as a key member of the Clinical Strategy Team, that is embedded within the Global Project Team, including taking primary responsibility for medical monitoring, data monitoring, and safety monitoring for the clinical development function  * Provide clinical/scientific knowledge into the development, design, delivery, and communication of the global evidence generation plan, working closely with Medical Affairs colleagues   * Support cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program   * Takes primary responsibility for the clinical development function, working with statisticians, modelers, and project team-members, for contributing to the creation of trial-specific statistical analysis plans, and for the interpretation, reporting, and dissemination of the final results, working closely with academic partners  * Contributes to and provides oversight of the operational aspects of study conduct including site selection and activation, site investigator and staff training, site start up and activation, screening and recruitment of trial participants, and trial close-out activities  * Leads the authoring and review of clinical parts of regulatory submissions, regulatory briefing documents, Investigational Brochures, scientific disclosures of trial results, and other relevant documents.    * Leads clinical responses to regulatory or IRB/Research Ethics Committee for information requests.   * Works with Key Opinion Leaders to incorporate their input into trial protocol designs, clinical development plans, clinical trial site selection, and regulatory interactions  * Ensures consistency of clinical content and scientific messages across abstracts, publications, and other external documents  * Contributes to the TPP (target product profile) and Global Product Safety (GPS) plans    * Give scientific presentations at advisory boards, trial academic committees, key scientific meetings, and other venues      Qualifications and Preferred Skills   * MD, or equivalent medical degress is required, and cardiology specialty training and cardiology board certification strongly preferred   * Minimum 10 years’ clinical development experience working cross-functionally in the regulated medical products industry is required.   * Experience designing and running Phase 1-3 trials, experience with preparation of and submissions of INDs and NDAs also preferred  * Leadership: Experience leading and motivating teams in a matrix environment is required. Proven interpersonal skills with ability to influence, resolve conflict and drive decisions among internal cross functional teams, executive management, and external teams.   * Strategic Agility: Ability to develop and execute complex strategies.   * Collaboration/Relationship Management: Ability to effectively collaborate in and across multiple functions, and with internal and external stakeholders of various backgrounds and skill sets. Skilled in establishing a collaborative and respectful environment.   * Influencing: Demonstrated ability to lead a matrixed team through influence. Proven track record of influence strategy, initiative(s) implementation, and decision-making. Proactively influences and motivates others to achieve objectives.   * Decision Making: Strong decision-making skills taking multiple perspectives into account and analytical skills are required; exercises sound business judgment that has broad organizational impact.   * Communication: Excellent communication skills (both orally and written) is critical to the success of the role.   * Business Excellence: Good at developing the processes necessary to get things done, knowing how to organize people and activities, and knowing what to measure and how to measure. Demonstrated ability to interpret data into actionable items   * Negotiation: Proven negotiation skills that effectively drive discussions and decisions to desired end results that have broad organizational impact.   * Alignment: Proven track record of achieving alignment with internal and external stakeholders      Exact Compensation may vary based on skills, experience and location.  Exact Compensation may vary based on skills, experience and location. Pay range $242,000—$347,000 USD