Senior Medical Director

Work Schedule

Environmental Conditions

Job Description

Purpose:

Advanced leadership responsibilities within the Pharmacovigilance (PV) physician team which may include direct line management accountability. Works collaboratively and serves as the primary point of contact between the PV physician group and other PV leaders (MPC group leadership etc). Provides leadership and strategy to multidisciplinary teams within PV and across the company not limited to PV operations training development business objectives quality initiatives and management process improvement compliance and innovation. Applies therapeutic area expertise and indication-specific knowledge to provide medical consultation and strategic direction and risk mitigation strategies to internal teams and clients. Supports business development activities. Manages (direct-line or matrix) mentors and oversees PV physicians globally to support training and end to end medical monitor and/or safety physician activities and supporting services across the pharmaceutical product life cycle. Encourages a culture of accountability and continuous process improvement. Develops and manages resource allocation plans and budgets.

Serves as the PV physician team liaison with other PPD departments and clients. May provide oversight of medical review and analysis of data for clinical trial serious adverse events aggregate review (e.g. trending and listings) marketed products ICSR and periodic safety reports (e.g. PBRER PSUR DSUR) and other client deliverables (e.g. labeling reconciliation documents CTD modules REMS RMP signal detection reports and CSR).

Essential Functions

• Provides global and regional medical leadership mentoring and oversight to direct reports (if applicable) and global PV physician team. Serves as a consultant and spokesperson of PV physician team or external spokesperson for the PV organization on significant matters.
• Utilizes subject matter clinical and pharmacovigilance expertise combined with knowledge of the product(s) or therapeutic area to interpretation of safety and efficacy data therapeutic and protocol training identify and evaluate safety signals and to drive decision-making on risk/benefit evaluation and argumentation pharmaco-epidemiological or clinical trial data interpretation and risk assessment if applicable.
• Creates formal networks with key decision makers. Collaborates with cross-functional group leaders to develop promote and contribute to strategic process improvement initiatives and planning of training and development programs.
• Serves as the primary point of contact for activities related to quality and reporting compliance of safety reports and as subject matter expert for these topics during audits and inspections.
• Assists in the development and implementation of policies to enhance the effectiveness of the PV department. Identifies unusual or significant issues related to safety and/or medical monitoring processes and proposes prevention and/or correction strategies.
• Provides insight and participates in new business/business development strategy calls proposal development bid reviews and parameters for business deliverables.
• Provides global leadership in medical safety and risk mitigation activities for projects and clients (e.g. primary point of contact) foster client relationships and supervises strategic sell initiatives of the PV department.
• Provides expertise and oversight of study start-up activities for medical deliverables.
• Communicates with sponsors to obtain direction and feedback on implementing program scope of work and performance.
• Actively participates in recruiting efforts and selection process.
• If applicable provides new hire onboarding salary administration performance management promotion and discharge activities and conflict resolution.
• Maintains understanding of contracts and budgets methods for recording time spent on project and administrative tasks expense submissions and travel.
• If applicable attends and contributes at MD management and allocation calls.
• Cultivates a supportive motivating and collaborative work environment. Builds an effective and productive team focused on overall corporate

Job Complexity

• Provides management & strategic direction to the business operation/corporate function. Participates with senior leadership in developing and authorizing the implementation of strategic business plans.

Job Knowledge

• Having broad experience or unique knowledge uses skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.

Supervision Received

• Assignments and objectives are largely tied to company-wide performance and guided by broad company policies and strategic plans.

Business Relationships

• Serves as principal consultant and spokesperson for the business unit or function on highly significant matters. Creates formal networks with key decision makers.

Qualifications:

Education and Experience:

• MD or equivalent required.
• History of an active medical license highly preferred.
• Total previous professional experience that provides the knowledge skills and abilities to perform to job (comparable to 12 years).
• Candidates should have clinical experience in treating patients in specialty or sub-specialty with direct responsibility for diagnostic and treatment decisions of at least 2 years and Clinical trial experience in a CRO pharmaceutical company or as a principal investigator in the industry of at least 5 years.

In some cases an equivalency consisting of a combination of appropriate education training and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.

Knowledge Skills and Abilities:

• Therapeutic and indication-specific development expertise across one or more therapeutic areas and/or one or more drug classes including deep knowledge of clinical program and study design relevant endpoints safety considerations and current regulatory and commercial landscape
• Deep knowledge of important regulatory considerations governing adverse event reporting and experience with FDA EMA and other national and international regulatory authorities
• Experience as a medical strategy leader for multidisciplinary teams with mastery of medical management tasks (review AEs protocol inquiries listings diagnostic reports data trending etc.) and/or safety tasks (signal detection activities aggregate report generation label update contribution dossier maintenance support and risk management activities)
• Thorough understanding of guidelines for marketing authorization submissions and international guidelines for conduct of clinical studies
• Strong decision-making negotiation and analytical skills
• Excellent communication and influencing skills
• Excellent organizational skills and detail-orientated leadership approach
• Ability to tactfully supervise and objectively evaluate medical staff
• Ability to mentor effectively in both one-on-one and in group settings
• Flexibility to travel domestically and internationally
• Ability to work independently on multiple tasks in a fast-paced environment
• Proficient in basic computer applications
• Overall knowledge of the drug development process
• Ability to effectively manage direct reports (if applicable)

Management Role:

Manager role with significantly larger management scope (e.g. global or regional responsibilities or multiple departments) OR mastery of manager skills and responsibilities as demonstrated by consistent multi-year successful performance. In some instances may be responsible for a functional area (as determined by executive management) and not have subordinate supervisors or employees.

Working Conditions and Environment:

• Work is performed in an office environment with exposure to electrical office equipment.
• Frequently drives to site locations and frequently travels both domestic and international.

Physical Requirements:

• Frequently stationary for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast simple repeated movements of the fingers hands and wrists.
• Moderate mobility required.
• Occasional crouching stooping bending and twisting of upper body and neck.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• Frequently interacts with others relates sensitive information to diverse groups both internally & externally.
• Ability to apply basic principles to solve conceptual issues.
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
• Regular and consistent attendance