Title: Medical Director, Senior Medical Director - Cardiology Location: Remote North Carolina United States of America Full time Remote The Medical Director provides medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed. Attends and presents at investigator and sponsor meetings, provides medical consultation to clients, investigators and project team members and supports business development activities. Provides medical review and analysis for clinical trial serious adverse events, marketed products ICSR and periodic safety reports ( e.g. PBRER, PSUR, DSUR) as well as other client deliverables (e.g. labeling reconciliation documents, CTD modules, REMS, RMP 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: Manage all medical aspects of contracted tasks across the pharmaceutical product life-cycle. General Support: - Ensure tasks delegated to PV are properly executed. Adhere to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues. Follow client SOPs/directives and project-specific WPDs for assigned projects. Comply with CRG’s corporate policies and SOPs/WPDs. - Provide medical consultation to team members and answer all study-related medical questions. Communicate clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately. - Provide therapeutic training and protocol training on assigned studies, as requested. - Assist in writing (interpretation of safety and efficacy data) and/or reviewing CSR, IND/NDA reports, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc., to ensure that the medical content is accurate and complete. Clinical Trial Support: - Monitor all safety variables (AE, laboratory abnormalities, changes in patient medical status, evaluation of prescribed concomitant medication for protocol restrictions, and un-blinding requests) of clinical studies. - Discuss all medical concerns with principal investigators and clients (e.g., interpretation of inclusion/exclusion criteria) raised during the course of a study, using proper medical judgment in interpretation and decision-making regarding clinical situations as they relate to the investigational study. - Provide medical review of adverse events of special interest, serious adverse events, and clinical outcomes events reported by study sites. - Perform data review as specified in the client contract and data validation manual, including review of coding listings and/or full safety data to assess potential safety concerns. Marketed Products Support: - Manage signal detection activities, scientifically review aggregate reports, contribute to label updates, and support dossier maintenance and risk management activities. - Medically review adverse event and serious adverse event data from all sources (solicited, spontaneous, literature, etc.) as contracted. Education and Experience Requirements: - MD or equivalent required. Active medical licensure preferred but not required. Candidates should have at least one of the following: - Clinical experience in treating patients in the specialty or sub-specialty (ie Cardiology residency/fellowship) associated with the applicants training (comparable to 2 years). - Suitable clinical trial experience in a Contract Research Organization, pharmaceutical company or as a principal investigator (comparable to 1-2 years) in the industry. - Direct experience in safety/Pharmacovigilance (comparable to 2 years). For Senior Medical Director: Candidates should have a combination of clinical experience and industry experience as follows: - Clinical experience in treating patients in the specialty or sub-specialty (ie Cardiology residency/fellowship) associated with the applicants training (comparable to 2 years) and one of the following: - Suitable clinical trial experience in a Contract Research Organization, pharmaceutical company or as a principal investigator (comparable to 1-2 years) in the industry; Or - Direct experience in safety/Pharmacovigilance (comparable to 2 years). Knowledge, Skills, Abilities: - Therapeutic expertise across one or more medical specialty or sub-specialties - Strong decision-making, problem solving, organizational skills and analytical skills - Excellent oral and written communication skills - Working knowledge of relevant safety databases (e.g. Medra) - Flexibility to travel domestically and internationally - Ability to work independently, analyze work with attention to detail, process and prioritize sensitive complex information - Proficiency in basic computer applications - Fluent in spoken and written English - Excellent interpersonal, influencing and team building skills - Understanding guidelines (FDA, ICH, EMA and GCP) - Working knowledge of biostatistics, data management, and clinical operations procedures - Ability to act as a mentor/trainer to other staff within PV

Role Description Do you crave an intellectually stimulating role that lets you apply your clinical expertise while continuing to grow and make an impact? As a Medical Director at EviCore, part of Evernorth Health Services, a division of The Cigna Group, you’ll leverage your background in genetics and genomics disciplines to deliver evidence-based medical reviews that support high-quality patient care. Collaborate with healthcare providers and stay current on healthcare regulations and industry developments as you review a wide range of cases. This role offers you the opportunity to build new skills while enhancing the health and vitality of others. We're seeking a detail-oriented individual with good communication, technology, and typing skills, as well as strong clinical judgment. Drive growth in your career with our innovative team. - You’ll start training remotely in a structured environment with support from trainers, mentors, and leadership to set you up for success. - Complete time-sensitive, specialized evidence-based medical case reviews for medical necessity on EviCore’s case management software. - Conduct physician consultation (peer-to-peer) calls with referring providers to discuss evidence-based medical necessity and appropriateness of the requested service or treatment. - Leverage your clinical expertise to recommend alternative services or treatments as necessary. - Work collaboratively with over 500 EviCore physician colleagues to help ensure patients receive proper care via evidence-based decision making. Qualifications - M.D. or D.O. with a current, active U.S. medical license and board certification (ABMS or AOA) in one or more of the following: Clinical Genetics and Genomics, Clinical Biochemical Genetics, Medical Biochemical Genetics, Clinical Cytogenetics and Genomics, or Molecular Genetic Pathology. - Eligible to acquire additional state licensure as required. - Clinical experience required. - 3 years of relevant clinical experience post residency/fellowship. - Knowledge of applicable state and federal laws, Utilization Review Accreditation Commission and National Committee for Quality Assurance standards is a plus. - Ability to commit to a set, weekly work schedule (Monday through Friday). - Strong computer skills: ability to work autonomously with automated processes, computer applications, and systems. - Meet physical demands of the role including, but not limited to, typing, speaking, and listening 100% of time. - In accordance with our HITECH Security Accreditation, company provided encrypted-workstation is required to be hard-wire connected to a modem or router. Wireless connection is not permitted. - If you will be working at home occasionally or permanently, the internet connection must be obtained through a cable broadband or fiber optic internet service provider with speeds of at least 10Mbps download/5Mbps upload. Benefits - Benefits start on day one. - Predictable work schedules. - 100% work from home. - 8 Paid Holidays + 23 PTO Days. - 401(K) with company match. - Reimbursement for continuing medical education. - Career growth opportunities across the enterprise. - Networking with peers across multiple medical specialties. Company Description Evernorth Health Services, a division of The Cigna Group, creates pharmacy, care and benefit solutions to improve health and increase vitality. We relentlessly innovate to make the prediction, prevention and treatment of illness and disease more accessible to millions of people. Join us in driving growth and improving lives.

Role Description The Medical Science Liaison (MSL/Sr. MSL) of US Medical Affairs Solid Tumor Gynecologic Oncology will report to the Regional Director MSLs, US Medical Affairs Solid Tumor Gynecologic Oncology. S/he will be a member of a field-based team within the Gynecologic Oncology-focused organization. The MSL/Sr. MSL is responsible for developing and enhancing professional relationships with medical thought leaders to support both Genmab approved products and those in various phases of clinical development. S/he provides scientific and clinical information through fair-balanced scientific exchange and supports new product launch excellence. The MSL/Sr. MSL executes field medical activities, collaborating with cross-functional field team members to ensure differentiated customer experience and optimal patient outcomes. Domestic Travel of Approximately 50% will be required. The Territory will be Southeast (Florida and Puerto Rico). Responsibilities - Identify key thought leaders and establish, foster, cultivate, and maintain relationships with healthcare providers (HCPs) in academic and community centers within assigned territory. - Develop and execute territory plans in alignment with regional and national (US) Medical Affairs strategies. - Provide insights/feedback on emerging scientific/clinical data that enhance the value and appropriate use of Genmab products as part of compliant collaboration with internal stakeholders. - Present appropriate clinical and scientific information to healthcare providers in response to unsolicited requests (as appropriate) in a fair and balanced manner. - Provide medical and scientific education related to disease state and Genmab products to healthcare providers. - Support product launches through HCP education for safe use of our medicines. - Act as the primary point of contact and facilitator for all aspects of investigator sponsored trials (ISTs), from submission, review and approval, through study activation/completion. - Collaborate effectively and proactively establish working relationships with cross-functional teams. - In collaboration with medical and clinical operations teams, drive engagement of HCPs involved in Genmab-sponsored trials. - Maintain up-to-date knowledge of products, clinical treatment trends, clinical trials, and scientific activities within the focused areas of interest for the gynecologic oncology team. - Serve as a scientific resource to commercial partners, as appropriate, to support pre-, peri-, and post-launch activities. - Support the execution, organization, and planning of advisory boards. - Professionally represent Genmab at select medical and scientific conferences and meetings. Qualifications - Advanced degree in health-related field (PharmD, PhD, or MD) strongly preferred. Candidates with clinical background (e.g., NP, PA, etc.) and extensive oncology MSL experience will be considered. - At least 2 years of MSL/Medical Affairs experience in Oncology/Solid Tumor focus preferred. - Strong knowledge and/or experience of healthcare and access environments. - Proven ability to work independently, as well as cross-functionally with numerous internal stakeholders in a highly matrixed environment. - Preferred experience on product launches or demonstrated success as product or therapeutic point. - Excellent interpersonal communication and presentation skills, strong personal integrity, teamwork abilities, and a customer focus are necessary. - Must be able to organize, prioritize, and work effectively in a constantly changing environment. - Strong compliance knowledge and adherence to corporate compliance policies. - Current working knowledge of FDA, OIG, ICH, GCP, PhRMA Code, HIPAA and other compliance regulations and guidelines relevant to industry interactions with healthcare professionals. - Demonstrated technical acumen including MS Office skills, ability to adopt and leverage multiple business applications. Requirements - For US based candidates, the proposed salary band for this position is as follows: $162,320.00---$243,480.00. - The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives. Benefits - 401(k) Plan: 100% match on the first 6% of contributions. - Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance. - Voluntary Plans: Critical illness, accident, and hospital indemnity insurance. - Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave. - Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support. - Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses.

Role Description The Senior Medical Director, Medical Affairs will provide medical management and professional medical support for clinical research projects at Worldwide Clinical Trials as the assigned Medical Monitor (MM). This role assists in activities requiring medical and scientific support, including but not limited to: - Assistance with feasibility assessments - Medical training - Provision of medical/clinical input to the design of study protocols and/or clinical development programs - Assistance with business development activities, as directed by the department head What you will do - Medically manages clinical trials to which they are assigned as MM - Serves as Global Lead MM (GLMM) for pan-regional and/or global trials to which they are assigned - Collaborates with other members of the Medical & Safety project team to process Serious Adverse Events (SAEs) - Provides therapeutic and protocol-specific training to the project teams - Contributes medical input into the design of clinical development programs, study protocols, research papers, client-focused white papers, etc. - Provides after-hours medical support for projects to which they are assigned - Independently supports Business Development through participation in proposal generation, feasibility assessments, review of proposals/contracts for medical services, and attendance at meetings with sponsors as directed by department senior management - Reviews and/or assists in the preparation of final study reports (CSRs) or other study documentation (protocols, ISS/ISEs, etc.) as directed by senior management - Maintains a high level of competence with assigned projects, including knowledge of project and therapeutic advances as well as marketplace developments - Interacts with staff in other functional areas within the company to ensure the highest level of client satisfaction through the successful execution of projects - Identifies, documents, and appropriately resolves out-of-scope work as directed by senior management - Assists in the annual attainment of departmental revenue targets and any other activities as directed by senior management - Maintains working knowledge of Good Clinical Practices (GCPs) and regulatory requirements relating to clinical development and safety - Mentors other medical staff as directed by senior management - Maintains clinical/therapeutic acumen in medical subspecialty through online and/or in-person scholarly programs/lectures - Demonstrates competence with the execution of SAE-related medical review in Worldwide Clinical Trials’ electronic safety database - Perform other duties as assigned Qualifications - Medical degree from an accredited institution of medical education - 6–8 years in the Contract Research Organization (CRO), pharmaceutical, or biotechnology industry in a medical monitoring or study physician role - Valid passport and ability to travel if required Requirements - Excellent computer skills (Word, Excel, Access) - Excellent spoken and written English skills - Excellent organizational and time management skills - Excellent communication skills - Excellent presentation skills Benefits - Equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law