Sr Med Dir - Pulmonary/Critical Care

Thermo Fisher Scientific•Morrisville, NC

About The Position

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. The Senior Medical Director 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). We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. What You'll Do: • Provide global and regional medical leadership, mentoring and oversight to direct reports (if applicable) and global PV physician team. Serve as a consultant and spokesperson of PV physician team or external spokesperson for the PV organization on significant matters. • Utilize subject matter clinical and pharmacovigilance expertise, combined with knowledge of the product(s) or therapeutic area to interpret safety and efficacy data, provide therapeutic and protocol training, identify and evaluate safety signals, and drive decision-making on risk/benefit evaluation and argumentation, pharmaco-epidemiological or clinical trial data interpretation, and risk assessment, if applicable. • Create formal networks with key decision makers. Collaborate with cross-functional group leaders to develop, promote, and contribute to strategic process improvement initiatives and planning of training and development programs. • Serve as the primary point of contact for activities related to quality and reporting compliance of safety reports, and act as subject matter expert for these topics during audits and inspections. • Assist in the development and implementation of policies to enhance the effectiveness of the PV department. Identify unusual or significant issues related to safety and/or medical monitoring processes and propose prevention and/or correction strategies. • Provide insight and participate in new business/business development strategy calls, proposal development, bid reviews, and parameters for business deliverables. • Provide global leadership in medical safety and risk mitigation activities for projects and clients (e.g., act as primary point of contact), foster client relationships, and supervise strategic sell initiatives of the PV department. • Provide expertise and oversight of study start-up activities for medical deliverables. • Communicate with sponsors to obtain direction and feedback on implementing program scope of work and performance. • Actively participate in recruiting efforts and the selection process. • If applicable, provide new hire onboarding, salary administration, performance management, promotion and discharge activities, and conflict resolution. • Maintain understanding of contracts and budgets, methods for recording time spent on project and administrative tasks, expense submissions, and travel. • If applicable, attend and contribute at MD management and allocation calls. • Cultivate a supportive, motivating, and collaborative work environment. Build an effective and productive team focused on overall corporate deliverables. Help ensure projects and initiatives align with company culture.

Requirements

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).
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.
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). 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.
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
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
Know how 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)

Responsibilities

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