Senior Medical Director
4 days ago
Austin
Job DescriptionDescription: SUMMARY: The Senior Medical Director (SMD) will play a critical role at the forefront of clinical research at Elligo Health Research. This role combines oversight of clinical trials with strategic medical leadership at an Integrated Research Organization (IRO). The SMD will lead clinical research programs as an Investigator across multiple therapeutic areas and serve as a primary medical authority for studies/trials conducted at the Elligo Clinical Research Center (ECRC). This individual will serve as a key medical and scientific leader, oversee protocol execution, ensure regulatory compliance, foster strong relationships with key stakeholders including sponsors, CRO’s, and contribute to the growth of the organization through local community partnerships to support enrollment goals. This position is ideal for a research-experienced physician who thrives in a dynamic, innovative environment and seeks to drive the development of cutting- edge therapies that improve patient outcomes and is skilled in adult chronic disease management. The SMD will provide mentorship to junior investigators, collaborate closely with operational leaders to optimize site performance, and participate in high-level strategy discussions that guide the future direction of the research center. ESSENTIAL DUTIES: • Serve as Principal Investigator (PI) / Sub-Investigator (Sub-I) at the Elligo Clinical Research Center and when necessary, as Sub-I on Elligo decentralized clinical trials., • Responsible for the conduct of clinical trials as per GCP/HSP guidelines to ensure participant safety, data integrity and responsibility for study staff., • Collaborate with leadership to identify opportunities for new research programs, therapeutic areas, and strategic partnerships., • Identify, develop and maintain partnerships with local community physicians/practices, organizations and community entities to support recruitment efforts, expansion of therapeutic area opportunities to drive revenue for the ECRC., • Maintain knowledge and clinical expertise in relevant therapeutic areas through ongoing professional development and conference participation. This includes experience in adult chronic disease management., • Provide thorough review of protocol and other study materials, • Determine clinical and practical “fit” for our practice partner sites by assessing study complexity, logistics, etc., • Collaborate with Feasibility and Operations to determine which studies are appropriate for which sites/investigators., • Collaborate with site operations, data management, and regulatory teams to ensure high-quality trial execution and patient safety., • Provide therapeutic and protocol specific training and supporting material for project teams and local investigators as indicated, and for internal operation’s needs., • Prepare risk assessments to determine potential pitfalls and issues that may occur during studies., • Participate in the development and medical review of recruitment and enrollment strategies and material., • Serve as a senior medical expert for ongoing trials, providing oversight on safety data, eligibility, and protocol adherence., • Provide medical and scientific knowledge on products and therapeutic areas to inform future growth., • Follow ethical and professional codes of conduct., • Interact with outside medical experts as required., • Adhere to the study plan by ensuring that all approvals are in place, vendors are qualified., • Provide input and participate in technology and other strategic committees as appropriate., • Comply with Elligo, Clinic, and Sponsor policies, standard operating procedures (SOPs), GCP guidelines, and documents according to ALCOA., • Perform other duties as required and/or assigned. SUPERVISORY RESPONSIBILITIES: • Promote a culture of scientific excellence, collaboration, and continuous learning., • Monitor employee productivity and provide constructive feedback and coaching., • Assess the work performance of staff and identify areas that need improvement., • Set and communicate goals for performance and deadlines in ways that comply with the company’s plans and vision, in addition to departmental objectives., • Ensure business goals, deadlines, and performance standards are met or exceeded., • Ensure adherence to legal and company policies and procedures and partner with Talent Services regarding recommended appropriate action., • Develop strong working relationships and maintain effective communication with team members. QUALIFICATIONS: • Expert knowledge of legal and ethical standards for the delivery of medical care., • Expertise regarding applicable compliance requirements including the ability to maintain quality, safety, and/or infection control standards., • Fully GCP trained and able to explain the importance of GCP guidelines to staff., • Ability to clearly explain and enforce clinical research participant safety requirements including safety reports, ICF elements, and role of the IRB, • Strong scientific, analytical, and problem-solving skills., • Collaborative spirit and dedication to team accomplishments, perseverance to overcome short-term challenges and accomplish long-term objectives., • Demonstrated ability to work collaboratively with cross functional departments/groups and different levels of employees to identify quality solutions and effectively achieve business results., • Self-motivated and able to work independently to complete tasks and respond to department requests., • Clear and concise written and verbal communication skills, including the ability to present ideas and suggestions clearly and effectively., • Strong organization/prioritization skills for the management of multiple concurrent projects and tasks., • Proactive and timely follow-up skills, including the ability to organize applicable department timelines and follow up with internal and external stakeholder needs as needed., • Exceptional ability to develop and maintain strong professional relationships with sponsors, key opinion leaders, and internal stakeholders., • Demonstrated ability to coordinate complex protocols with overlapping timelines., • Proven ability to lead cross-functional teams and manage complex clinical programs., • Knowledge of related accreditation and certification requirements, including ongoing engagement in maintenance of certification for primary board certification., • Ability to travel for Clinic activities, and attend investigator meetings or vendor visits/audits, as required., • Demonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePoint) and with clinical trial master filing systems and eSource. EDUCATION AND EXPERIENCE: • MD, DO degree required from a U.S. accredited Medical School., • Active Board Certification is required., • Current and Active license to practice medicine in the U.S., • Eight (8) or more years of healthcare experience in a U.S. community practice setting, including in adult chronic disease management., • Minimum two (2) years of experience FDA clinical research as a Principal or Sub-Investigator. Inclusion of experience as a PI on GLP-1 studies that were at least a 12 month study. ENVIRONMENT: This is a clinical site-based position operating at the clinical research facility. This role routinely uses standard office equipment such as computers, printers, copiers, and phones. The clinical work environment involves exposure to potentially dangerous materials and situations that require extensive safety precautions and may include the use of protective equipment. Additionally, will work with blood or blood-borne pathogens. Approximately 10% travel may be required to support the position’s responsibilities. PHYSICAL DEMANDS: The physical requirements described here are representative of those that must be met by an employee to successfully perform the functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee may be required to: • Regularly work at a desk using a computer for prolonged periods., • Perform repetitive motion with substantial movements (motions) of the wrists, hands, and/or fingers., • Regularly communicate via e-mail, telephone, chat, webcam (remote sessions such as MS Teams or Zoom), so others will understand and exchange accurate and timely information., • Ability to give and receive information through speaking and listening., • Frequently stand/walk, grasp objects, perform lightly/fine manipulation of objects, and use hands to perform physical examination on patients., • Occasionally move safely over uneven surfaces., • Occasionally reach/work above shoulders, twist/bend/stoop/squat, grasp forcefully, lift/carry/push/pull objects that weigh up to 20 pounds., • Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. ADDITIONAL: Elligo Health Research is a dynamic organization in a rapidly changing industry. Accordingly, the responsibilities associated with this job may change from time to time in accordance with business needs. More specifically, the incumbent may be required to perform additional and/or different responsibilities from those set forth above. The above declarations are not intended to be an all-inclusive list of the duties and responsibilities of the job described, nor are they intended to be such a listing of the skills and abilities required to do the job. Rather, they are designed only to describe the general nature of the job. The incumbent must be flexible as there may be workweeks that require more than 40 hours to ensure the position’s expectations and responsibilities are met. Elligo Health Research is committed to a policy of equal employment and will not discriminate against an applicant or associate based on his or her age, sex, sexual orientation, gender identity, race, color, creed, religion, national origin or ancestry, citizenship, marital status, familial status, physical or mental disability, handicap, military or veteran status, genetic information, pregnancy or any other category protected under federal, state or local law, regulation or ordinance. Requirements: • MD, DO degree required from a U.S. accredited Medical School., • Active Board Certification is required., • Current and Active license to practice medicine in the U.S., • Eight (8) or more years of healthcare experience in a U.S. community practice setting, including in adult chronic disease management., • Minimum two (2) years of experience FDA clinical research as a Principal or Sub-Investigator. Inclusion of experience as a PI on GLP-1 studies that were at least a 12 month study.
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