Senior Medical Director, Clinical Development

Company: Aerotek
Location: Newark
Posted on: April 9, 2021

Job Description:

Description:Reporting to the EVP of Clinical Development, the Senior Medical Director is a leadership role within Clinical Development offering strategic input into early and late stages of development plans, study designs, publication strategies, safety monitoring and product labeling. The role will provide leadership on translational and clinical research decisions in partnerships with translational and biomarker research scientists, clinical pharmacologists, Medical Monitors, Investigators, Key Opinion Leaders, Biostatisticians and the study team. The role will be a key stakeholder at Health Authority engagements and cross-functional team discussions, including Regulatory, Clinical Operations, Biostatistics, CMC, Safety and at the Executive Level.Responsibilities

• Strategize and implement innovative early (First-in-Human)/Proof of Concept and late (registrational) clinical development programs including clinical protocol design and overall development strategy
• Contributes to the design, development and interpretation of PK/PD studies that best characterize key compound attributes
• Prepare clinical development plans that integrate pre-clinical and early clinical findings while working to ensure cross-functional alignment on an ongoing basis throughout the early phases of clinical development
• Establish, oversee and lead the Pharmacovigilance function including oversight of Drug Safety (and CRO activities) to ensure accurate, timely and complete reporting of safety events
• Assist in the preparation and review of INDs, investigator brochures, protocols, informed consent forms, and clinical study reports.
• Provide leadership in the preparation of expedited and aggregate safety reports
• Provide medical oversight of clinical trials and serve as Medical Monitor on designated trials or oversee assigned Medical Monitors
• Provide leadership on disease state training and medical expertise including the presentation of product background and clinical trial results
• Collaborate with biostatistics to establish sample size scenarios, statistical analysis plans and other study deliverables
• Lead publication plans and provide scientific and medical contributions to publications and presentations
• Contribute to clinical documents within INDs/CTAs as well as NDAs/NDSs with strategic positioning of data, document review and writing.
• Oversee clinical data review, trends and interpretation.
• Contribute to regulatory activities, such as Briefing Document preparation, FDA interactions and Information Requests.
• Contribute to and/or lead advisory boards, data safety monitoring boards and key opinion leader discussions.
• Align departmental activities in support of corporate goals, as appropriate.
• Manage and mentor clinical staffTop Skills Details:Experience negotiating with the FDA MD (or MD/PhD) Medical Oncology, Nuclear medicine, or RadiologyMinimum of 8 years' experience in the biotech or pharmaceutical industry with at least 3 years' experience managing direct reportsAdditional Skills & Qualifications:MD (or MD/PhD) with board eligibility or accreditation, preferably in Medical Oncology, Nuclear medicine, or RadiologyThorough understanding of oncology drug development and approval processesKnowledge of clinical pharmacology and its relationship to decision-making in early drug development.Demonstrated success in translational and clinical study design, FDA discussions and data analysisExperience with design, execution and analysis of Phase 1-3 clinical studies preferred.Experience in theragnostic development preferredTechnical understanding of eCTD submission requirements, the CFR, GCP/ICH.Excellent interpersonal, communication and presentation skillsAbility to manage multiple projects and shifting prioritiesExperience Level:Expert Level About Aerotek:We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Aerotek, Newark , Senior Medical Director, Clinical Development, Healthcare , Newark, New Jersey