Director of Medical Affairs

Summary: Serves as the medical expert for assigned clinical trials. Ensures safe, reliable, and successful conduct of clinical drug research through the direction and supervision of activities by performing the following duties personally or through subordinate staff. Performs duties in accordance with company’s values, policies and procedures. Oversees and manages medical monitor staff.

Essential Duties and Responsibilities include the following. Other duties may be assigned at the Company’s sole discretion.

• Serves as the medical expert and oversees medical safety of human trials conducted by ProSciento.
• Advises on trial-related medical questions or problems.
• Reviews line listings of adverse events for coding and trends to assess the impact of a given event on the patient, to other patients within the study and to the overall integrity of the study.
• Supports the pharmacovigilance team with case processing and reporting as specified in the Safety Management Plan.
• Reviews safety data to verify the overall consistency of the data and reported severity of adverse events as specified in the Medical Monitoring Plan.
• Reviews proposed clinical trials for scientific value, ethical considerations, and safety concerns; provides feedback to Scientific Services and Clinical Operations teams as required.
• Reviews Investigator’s Brochure and final protocol in detail prior to study start.
• Provides guidance and support to contracted study sites and associated investigators for medical safety and protocol questions.
• Supports clinical study protocol (CSP), Medical Monitoring Plan (MMP), Safety Management Plan (SMP), and Clinical Study Report (CSR) development, as needed.
• Assists in medical review, assessment, and interpretation of clinical and safety data to ensure that the data are correct and presented with the appropriate medical interpretation.
• Supports site and investigator training activities; participates in investigator meetings, if necessary.
• Maintains communications with Clinical Project Manager, clinical trial sites, and sponsors during conduct of the clinical trials; attends relevant teleconferences, including dose escalation meetings.
• Supervises the conduct of clinical trials for accuracy and efficacy in accordance to the highest clinical research standards (GCP/ICH) standards, clinical standards, and to all applicable FDA regulations.
• Will oversee medical monitor staff.
  
  
  

Competencies:

• Timely Decision Making: Makes decisions in a timely manner, sometimes with incomplete information and under tight deadlines and pressure; able to make a quick decision.
• Managing and Measuring Work: Clearly assigns responsibility for tasks and decisions; sets clear objectives and measures; monitors process, progress, and results; designs feedback loops into work.
• Organizational Agility: Knowledgeable about how organizations work; knows how to get things done both through formal channels and the informal network; understands the origin and reasoning behind key policies, practices, and procedures; understand the cultures of organizations.
• Process Management: Good at figuring out the processes necessary to get things done; knows how to organize people and activities; understands how to separate and combine tasks into efficient workflow; knows what to measure and how to measure it; can see opportunities for synergy and integration where others can’t; can simplify complex processes; gets more out of fewer resources.
• Strategic Agility: Sees ahead clearly; can anticipate future consequences and trends accurately; has broad knowledge and perspective; is future oriented; can articulately paint credible pictures and visions of possibilities and likelihoods; can create competitive and breakthrough strategies and plans.
  
  
  

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and Experience:

Medical degree and/or equivalent. 3-5 years related experience and/or comparable experience in a director or supervisory role. Experience with technical, clinical, regulatory, and managerial aspects of clinical research. Experience with current standards of Good Clinical Practice and familiarity in working with FDA, DEA, ICH, state, and other regulations relevant to the conduct of clinical drug research.

Language Ability:

Ability to read, analyze, and interpret the most complex documents. Ability to respond effectively to inquiries or issues. Ability to create written documentation and/or articles assimilating scientific data into comprehensive formats. Ability to make effective and persuasive speeches and presentations on complex topics.

Math Ability:

Ability to comprehend and apply principles of modern algebra and advanced statistical theory.

Reasoning Ability:

Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables. Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format.

Computer Skills:

To perform this job successfully, an individual should have advanced knowledge and experience using the current MS Office Word and Excel.

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 individuals with disabilities to perform the essential functions.

The noise level in the work environment is usually moderate.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus. While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear.

The above job description does not imply these outlined duties are the only duties performed by this employee. The incumbent is expected to perform other related duties necessary for the effective operation of the department and company.

ProSciento reserves the right to change or alter any of the above duties and responsibilities according to the operational needs of the department and company.

ProSciento is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.