SUMMARY:

The Senior Medical Director, DCT (SMD, DCT) 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 for Decentralized Clinical Trials (DCT) conducted by Elligo Health Research. The SMD, DCT will lead clinical research programs as an Investigator across multiple therapeutic areas. 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. 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 and study execution models that improve patient outcomes. The SMD, DCT will collaborate closely with operational leaders to optimize study conduct and participate in high-level strategy discussions that guide the future direction of the decentralized clinical research.

ESSENTIAL DUTIES:

• Serve as Principal Investigator (PI) / Sub-Investigator (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.
• Maintain knowledge and clinical expertise in relevant therapeutic areas through ongoing professional development and conference participation.
• 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 operations 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 form a U.S. accredited Medical School.
• Active Medical 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.
• Minimum two (2) years of experience FDA clinical research as a Principal or Sub-Investigator.