Vice President, Medical Affairs
3 weeks ago
Job Summary
The Vice President, Medical Affairs is responsible for leading the development and execution of strategic and tactical plans for Headquarter (HQ) and Field medical affairs teams pre-launch, launch, and post approval for biosimilars and biologic products. This leader is an active and collaborative member of the Biosimilar Leadership Team (BLT). Leads local and collaborates on global product and business development activities. Serves as strong medical lead working with cross-functional counterparts regionally and globally to ensure strong execution against corporate goals and objectives in line with federal, state and company compliance requirements. Strong, motivational leader who builds and leads medical affairs team to ensure high quality, compliant execution against medical affairs performance goals.
*While this position may be worked remotely, qualified candidates must be permanently authorized to work in the U.S., and must work inside the U.S.
Responsibilities
Develop and ensure execution of impactful medical affairs strategy and tactics for HQ and Field teams to support product development, pre- and post-launch activities as aligned with the SVP, Chief Medical Officer.
Collaborate with direct reports and MSL Senior Managers/Field Directors to align on and oversee MSL onboarding, training, resource development and impactful execution of in-field territory plans across oncology and immunology.
Lead HQ team to ensure impactful strategic and tactical execution of key medical affairs initiatives including: IIT evaluation, study design/execution, evidence generation, multi-channel medical communication/education, consulting, MRL review and Medical Information.
Maintain a high level of professional expertise by staying abreast of the current medical landscape with regard to key therapeutic areas (e.g., oncology, immunology) and related products.
Work with broader Medical Affairs team to identify, build relationships with, and provide insights from, KOLs, decision makers and influencers in the HCP community.
Medical expert for US to review, develop, and approve clinical summaries in support of BLA, NDA, and ANDA applications.
Medical expert who provides, and trains others in the organization to provide, scientifically accurate, fair-balanced, clear, concise (yet comprehensive) medical information targeted to appropriate audiences regarding disease state, business landscape and key product information to external and internal customers.
Serve as a US medical expert/point person providing due diligence on business development opportunities for products in development as well as potential acquisition targets.
Train and facilitate other members of the team to train staff regarding current knowledge of disease/treatment landscape, applicable local and global regulations, standard operating procedures, and guidelines.
Responsible for writing, and/or training team to write/review relevant Standard Operating Procedures (SOPs) as needed.
Job Requirements
Medical/clinical professional degree required (PharmD, MD, PhD).
15+ years of experience in the pharmaceutical industry (predominantly in a medical affairs or clinical development role) required (supporting Biosimilars or Biologics preferred). Clinical experience will also be considered (7+ years preferred).
Pharmacology (PK/PD) knowledge and ability to communicate key concepts and study findings required.
Ability to understand and interpret the regulatory requirements under which drugs are developed, reviewed, and supported after approval.
Experience with the clinical drug development process.
Significant experience leading larger teams including HQ and/or Field required.
Clinical and scientific research and writing skills required. Ability to critically evaluate the published medical and scientific literature and approve and write comprehensive, medically ac
-
Senior Associate Vice President, Marketing
1 week ago
Detroit, Michigan, United States Wayne State University Full timeSenior Associate Vice President, Marketing & CommunicationsWayne State University is searching for an experiencedSenior Associate Vice President, Marketing & Communicationsat its Detroit campus location.Wayne State is a premier, public, urban research university located in the heart of Detroit, Michigan where students from all backgrounds are offered a rich,...
-
Senior Associate Vice President, Marketing
24 hours ago
Detroit, Michigan, United States Wayne State University Full timeSenior Associate Vice President, Marketing & CommunicationsWayne State University is searching for an experiencedSenior Associate Vice President, Marketing & Communicationsat its Detroit campus location.Wayne State is a premier, public, urban research university located in the heart of Detroit, Michigan where students from all backgrounds are offered a rich,...
-
Associate Vice President
1 week ago
Detroit, Michigan, United States Tata Technologies Full timeTata Technologies Inc.: Associate Vice President -- Detroit, MI DUTIES:Function as Subject Matter Expert in the Industrial Heavy Machinery DomainSupport bid response and management across bid lifecycle with a creative mindset towards the articulation of enterprise applications capabilities (for the manufacturing industry) via technical presentations,...
-
Associate Vice President
1 week ago
Detroit, Michigan, United States Tata Technologies Full timeTata Technologies Inc.: Associate Vice President -- Detroit, MI DUTIES:Function as Subject Matter Expert in the Industrial Heavy Machinery DomainSupport bid response and management across bid lifecycle with a creative mindset towards the articulation of enterprise applications capabilities (for the manufacturing industry) via technical presentations,...
-
Associate Vice President
1 day ago
Detroit, Michigan, United States Tata Technologies Full timeTata Technologies Inc.: Associate Vice President -- Detroit, MI DUTIES:Function as Subject Matter Expert in the Industrial Heavy Machinery DomainSupport bid response and management across bid lifecycle with a creative mindset towards the articulation of enterprise applications capabilities (for the manufacturing industry) via technical presentations,...
-
Vice President, Enterprise Accounts
6 days ago
Detroit, Michigan, United States Allied Universal Full timeAllied Universal, North America's leading security and facility services company, provides rewarding careers that give you a sense of purpose. While working in a dynamic, diverse and inclusive workplace, you will be part of a team that fuels a culture that will reflect in our communities and customers we serve. We offer medical, dental and vision coverage,...
-
Vice President, Enterprise Accounts
1 day ago
Detroit, Michigan, United States Allied Universal Full timeAllied Universal, North America's leading security and facility services company, provides rewarding careers that give you a sense of purpose. While working in a dynamic, diverse and inclusive workplace, you will be part of a team that fuels a culture that will reflect in our communities and customers we serve. We offer medical, dental and vision coverage,...
-
Senior Director, Medical Affairs
3 weeks ago
Detroit, Michigan, United States Fresenius Kabi USA LLC Full timeJob SummaryThe Senior Director, Medical Affairs will provide global medical leadership for the R&D function of the Fresenius Kabi MedTech business, which includes medical devices and solutions associated with transfusion, cell therapies, and infusion technology. Participate in and guide risk management inputs for development projects, support definition and...
-
Senior Director, Medical Affairs
24 hours ago
Detroit, Michigan, United States Fresenius Kabi USA LLC Full timeJob SummaryThe Senior Director, Medical Affairs will provide global medical leadership for the R&D function of the Fresenius Kabi MedTech business, which includes medical devices and solutions associated with transfusion, cell therapies, and infusion technology. Participate in and guide risk management inputs for development projects, support definition and...
-
Detroit, Michigan, United States teamworkonline Full timeAmaze, Inspire, UniteJob Summary:The Vice President, Corporate Partnerships Activation is responsible for developing and executing the corporate partnerships activation strategy in line with business objectives and departmental goals. Also leads the relationship management and implementation of integrated partnerships throughout the sports & entertainment...
-
Detroit, Michigan, United States teamworkonline Full timeAmaze, Inspire, UniteJob Summary:The Vice President, Corporate Partnerships Activation is responsible for developing and executing the corporate partnerships activation strategy in line with business objectives and departmental goals. Also leads the relationship management and implementation of integrated partnerships throughout the sports & entertainment...
-
Director of Utilization Management
3 weeks ago
Detroit, Michigan, United States Detroit Wayne Integrated Health Network Full timeDirector of Utilization ManagementUnder the general supervision of the Vice President of Clinical Operations for the Detroit Wayne Integrated Health Network (DWIHN), the Director of Utilization Management is responsible for managing the day-to-day operations of the Utilization Management Program and staff. This position oversees all phases of development,...
-
Sr. Regulatory Affairs Specialist, CS
1 week ago
Detroit, Michigan, United States Getinge Full timeAt Getinge we have the passion to perform Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge, our passion is to secure that every person and community have access to the best possible care, offering hospitals and life science institutions products and solutions that aim to...
-
Program Specialist
1 week ago
Detroit, Michigan, United States Veterans Affairs, Veterans Health Administration Full timeSummary This position functions as the Decedent Affairs Program Specialist and is responsible to manage the daily business operations of the Decedent Affairs program. Work includes program administration, providing Decedent Services, data management and analysis, and providing liaison and fiscal management services. Responsibilities The incumbent serves in a...
-
Program Specialist
20 hours ago
Detroit, Michigan, United States Veterans Affairs, Veterans Health Administration Full timeSummary This position functions as the Decedent Affairs Program Specialist and is responsible to manage the daily business operations of the Decedent Affairs program. Work includes program administration, providing Decedent Services, data management and analysis, and providing liaison and fiscal management services. Responsibilities The incumbent serves in a...
-
Chief Financial Officer
1 month ago
Detroit, Michigan, United States United Way for Southeastern Michigan Full timeChief Financial OfficerUnited Wayfor Southeastern MichiganThe OrganizationAbout United Way for Southeastern MichiganTo mobilize the caring power of Detroit and SoutheasternMichigan to improve communities and individual lives in measurableand lasting ways.In Southeastern Michigan, 40 percent of families struggle tomeet their basic needs. United Way for...
-
Detroit, Michigan, United States WSP USA Full timeThis OpportunityProvides high level technical assistance and guidance multi-site/phase water resources engineering work processes, due diligence, investigation, remediation, impact assessment, and environmental permitting projects. Tasks may include the design and development of processes, infrastructure, and operating strategies related to water supply,...
-
Detroit, Michigan, United States WSP USA Full timeThis OpportunityProvides high level technical assistance and guidance multi-site/phase water resources engineering work processes, due diligence, investigation, remediation, impact assessment, and environmental permitting projects. Tasks may include the design and development of processes, infrastructure, and operating strategies related to water supply,...
-
Chief Medical Officer-Associate
1 week ago
Detroit, Michigan, United States Henry Ford Health System Full timeResponsible for implementing strategy and for operational leadership, efficiency, value and utilization, medical staff oversight, and care experience initiatives. Reports to the Chief Medical Officer of Henry Ford Hospital. PRINCIPLE DUTIES AND RESPONSIBILITIES Ensures and promotes the delivery of high-quality care by providing clinical oversight of...
-
Staff Physician
1 week ago
Detroit, Michigan, United States Department Of Veterans Affairs Full timeSummaryThis position is eligible for the Education Debt Reduction Program (EDRP), a student loan payment reimbursement program. You must meet specific individual eligibility requirements in accordance with VHA policy and submit your EDRP application within four months of appointment. Approval, award amount (up to $200,000) and eligibility period (one to five...
