Job Description

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Job Title: Executive Medical Director, Medical Affairs Job Location: United States or Canada - Remote Job Overview: Primary responsibilities include provision of internal and external drug development, regulatory strategy, and medical affairs consulting to Company project teams and clients. Responsibilities also include medical oversight of clinical trials to ensure company SOPs, sponsor directives, and patient safety regulatory requirements are followed. Position provides medical consulting services internally and externally. External services include: medical monitoring oversight of programs and/or working on individual studies, contributing to feasibility assessments, and business development/public relations. Ability to interface with and manage clinical investigators, serving as a voice for Company and Sponsors is critical. Job Duties and Responsibilities:

• Contribute to clinical development plans for Company clients.
• Collaborate with Company Regulatory Services Division to determine regulatory submission strategy and approval pathway for Company clients.
• Support Business Development activities through participation in core proposal team activities, development of protocol considerations, feasibility assessments, review of proposals/contracts for medical services, attending and presenting at investigator and sponsor meetings and attendance at meetings with sponsors.
• Medical oversight of global trials or programs to ensure company SOPs, sponsor directives and applicable regulatory requirements are followed. Includes providing medical consultation to sponsors and project team members for clinical trial activities, review of data, and the management of SAEs.
• Works closely with Project Management to ensure that medical operational functions are executed effectively and that teams are adequately trained in key therapeutic areas and indications.
• May participate in Data Safety Monitoring Committees and/or Safety Monitoring Committees (SMC) on assigned clinical trials.
• Develops study documents and reports, including protocols and relevant sections of regulatory submissions. Assesses and interprets trial results. Leverages clinical trial experience, medical knowledge and project management skills as needed to support exceptional service delivery.
• Identifies and coordinates involvement of medical specialists, as needed, to support project delivery, site feasibility and enrollment/retention strategies as appropriate.
• Provides training for in-house personnel.
• Serves as Company\xe2\x80\x99s voice of medical and scientific depth. Develops opportunities for publishing, speaking, and other means of gaining public exposure and credibility for the company.

Supervisory Responsibilities:

• Supervisory responsibilities, as assigned.

Job Requirements: Education

• MD/DO required. (Nephrologist prefered)
• Post-graduate training required.
• Board certification is preferable.

Experience

• Nephrologist or physician with extensive expeirnece with ephrology / hypertension study experience.
• Clinical background in internal medicine and/or subspecialty practice.
• CRO experience preferred.
• At least 10-15 years of clinical and/or clinical development experience within pharmaceutical, biotech, medical device and/or CROs.
• Prior background in conducting clinical trials, either as an investigator or in pharmaceutical industry a plus.
• Demonstrable experience in Regulatory Affairs and strategic drug development; interaction with US FDA and/or other global regulatory authorities helpful.
• Demonstrable experience in writing or editing protocols, study reports, abstracts, and/or regulatory submissions.
• Experience in cultivating business contacts and projects.

Skills/Competencies

• In-depth knowledge of drug development and regulatory approval process including phase I-III clinical trials.
• Excellent knowledge of ICH/GCP, FDA, and other country specific regulations and guidelines. Able to train others and to apply guidelines and regulations to document review.
• In-depth knowledge of the healthcare development process and clinical trials.
• Proficient in the use of computers and standard office programs.
• Demonstrated interest and knowledge in development of technology solutions and application development.
• Flexibility to work in a variety of scientific/therapeutic disciplines.
• Demonstrated experience in hiring, training, mentoring and developing staff.
• Demonstrated ability to effectively manage a team.
• Experience working with personnel who have varied technical and educational backgrounds.
• Effective oral and written communication and presentation skills.
• Creative problem-solving skills.
• Ability to work in a fast-paced team-oriented environment.

Capabilities

• Domestic and international travel, as needed. Estimated 10% - 30%.

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