Job Description

Locations

• United States – Remote (Remote)

Skills Required

• pharmaceutical industryintermediate
• Medical Affairsintermediate
• developing effective abstractsintermediate
• FDA regulationsintermediate

Required Qualifications

• Bachelor's Degree and 12 Years' Experience (experience, 12 years)
• Bachelor's Degree and 12 Years' Experience (experience, 12 years)
• Masters' Degree and 10 Years' Experience (experience, 10 years)
• Masters' Degree and 10 Years' Experience (experience, 10 years)
• PhD/PharmD and 8 years’ experience (experience, 8 years)
• PhD/PharmD and 8 years’ experience (experience, 8 years)

Preferred Qualifications

• Advanced medical, scientific or clinical degree (e.g., PhD, MD, PharmD, NP or PA) with 8+ years' experience in the pharmaceutical industry or healthcare setting. (experience, 8 years)
• Advanced medical, scientific or clinical degree (e.g., PhD, MD, PharmD, NP or PA) with 8+ years' experience in the pharmaceutical industry or healthcare setting. (experience, 8 years)
• Industry experience in Medical Affairs. (experience)
• Industry experience in Medical Affairs. (experience)
• Oncology experience and experience working with Community Oncology practices and/or organizations is preferred. (experience)
• Oncology experience and experience working with Community Oncology practices and/or organizations is preferred. (experience)
• Strong business acumen; translation of scientific expertise and knowledge to achieve the identified goals of the company. (experience)
• Demonstrated ability to think strategically and translate that strategy into an actionable work plan. (experience)
• Excellent written, verbal, interpersonal, relationship-building, negotiating, and communication skills. (experience)
• Capacity to develop and deliver high-quality presentations is essential. (experience)
• Excellent project management and organizational skills to support project planning across multiple activities, and to anticipate and prioritize workloads. (experience)
• Affinity for a collaborative, team-oriented environment and approach; ability to network and partner with both internal and external stakeholders, including C-suite and HCPs across academic institutions, community practices, societies, and third parties. (experience)
• Attention to detail and ability to meet timelines in a fast-paced environment. (experience)
• Excellent analytical and problem-solving skills; demonstrated ability to identify and understand complex issues and problems; ability to identify and query key findings from study data and publications. (experience)
• Experience in developing effective abstracts, manuscripts, posters, and slides as well as presenting at scientific meetings. (experience)
• Must be fully cognizant of, and adhere to, regulatory, legal, and compliance requirements for clinical trials and related Medical Affairs activities; thorough knowledge of FDA regulations, ICH guidelines, and GCPs governing the conduct of clinical trials is preferred. (experience)
• Demonstrated ability to work with a high level of autonomy and independence. (experience)
• Ability to travel up to 70% of the time and occasionally on short notice.Mainly US travel and includes (but not limited to) travel within territory, travel to national and regional meetings, and travel to headquarters (HQ). (experience)
• Strong business acumen; translation of scientific expertise and knowledge to achieve the identified goals of the company. (experience)
• Demonstrated ability to think strategically and translate that strategy into an actionable work plan. (experience)
• Excellent written, verbal, interpersonal, relationship-building, negotiating, and communication skills. (experience)
• Capacity to develop and deliver high-quality presentations is essential. (experience)
• Excellent project management and organizational skills to support project planning across multiple activities, and to anticipate and prioritize workloads. (experience)
• Affinity for a collaborative, team-oriented environment and approach; ability to network and partner with both internal and external stakeholders, including C-suite and HCPs across academic institutions, community practices, societies, and third parties. (experience)
• Attention to detail and ability to meet timelines in a fast-paced environment. (experience)
• Excellent analytical and problem-solving skills; demonstrated ability to identify and understand complex issues and problems; ability to identify and query key findings from study data and publications. (experience)
• Experience in developing effective abstracts, manuscripts, posters, and slides as well as presenting at scientific meetings. (experience)
• Must be fully cognizant of, and adhere to, regulatory, legal, and compliance requirements for clinical trials and related Medical Affairs activities; thorough knowledge of FDA regulations, ICH guidelines, and GCPs governing the conduct of clinical trials is preferred. (experience)
• Demonstrated ability to work with a high level of autonomy and independence. (experience)
• Ability to travel up to 70% of the time and occasionally on short notice. (experience)
• Mainly US travel and includes (but not limited to) travel within territory, travel to national and regional meetings, and travel to headquarters (HQ). (experience)

Responsibilities

• Support the development (in collaboration with the CCC Lead) of strategies and implementation plans to define and address education, research, and Medical Affairs insights and data generation needs within US Community Oncology practices.
• Prepare presentation materials and present scientific data at internal meetings and external advisory boards.
• Co-create a RWE generation plan in conjunction with key US Community Oncology practices and initiate key RWE studies to support the use of Trodelvy in breast cancer with the potential to expand to other molecules, indications, and disease areas.
• Provide medical and scientific leadership and support at key scientific meetings (including society engagement) with US HCPs and patients, with a focus on Community Oncology practices.
• Serve as an educational resource and trainer to Gilead colleagues, including the US Medical Science Liaisons (MSLs) / Medical Key Account Liaisons (MKALs), including medical educational activities, grants, and investigator-sponsored/collaborative studies.
• Collaborate with Medical Affairs Research (MAR), the Global Review Committee (GRC) / Local Review Committee (LRC) teams, and Clinical Research and Development (R&D) as needed.
• Lead the delivery of timely, accurate, and succinct communication of fair-balanced clinical and scientific presentations to Community Oncology healthcare professionals, both proactively and in response to requests for information, consistent with promotional compliance and regulatory requirements.
• Participate in the editorial review of all relevant scientific content to ensure strategic alignment and accuracy.
• Support data generation activities through:Critical review of global investigator-sponsored research (ISR) / collaborative, Ph3b, and Ph4 study proposals generated in the US Community Oncology practices.Review abstracts and/or manuscripts that result from collaborative and RWE studies generated from Community Oncology practices.Communicate Gilead’s commitment to scientific excellence through research and education in Community Oncology practices.
• Collaborate effectively and in a compliant manner with colleagues in other functional areas within Gilead.
• Support the development, deployment, and appropriate use of field tools and resources (e.g. slide decks) for the CCC.
• Lead and shepherd oncology medical assets (i.e. field resources) through the Medical Review Committee (MRC) process, in consultation with cross-functional Medical Affairs team members.
• Support the development (in collaboration with the CCC Lead) of strategies and implementation plans to define and address education, research, and Medical Affairs insights and data generation needs within US Community Oncology practices.
• Prepare presentation materials and present scientific data at internal meetings and external advisory boards.
• Co-create a RWE generation plan in conjunction with key US Community Oncology practices and initiate key RWE studies to support the use of Trodelvy in breast cancer with the potential to expand to other molecules, indications, and disease areas.
• Provide medical and scientific leadership and support at key scientific meetings (including society engagement) with US HCPs and patients, with a focus on Community Oncology practices.
• Serve as an educational resource and trainer to Gilead colleagues, including the US Medical Science Liaisons (MSLs) / Medical Key Account Liaisons (MKALs), including medical educational activities, grants, and investigator-sponsored/collaborative studies.
• Collaborate with Medical Affairs Research (MAR), the Global Review Committee (GRC) / Local Review Committee (LRC) teams, and Clinical Research and Development (R&D) as needed.
• Lead the delivery of timely, accurate, and succinct communication of fair-balanced clinical and scientific presentations to Community Oncology healthcare professionals, both proactively and in response to requests for information, consistent with promotional compliance and regulatory requirements.
• Participate in the editorial review of all relevant scientific content to ensure strategic alignment and accuracy.
• Support data generation activities through:
• Critical review of global investigator-sponsored research (ISR) / collaborative, Ph3b, and Ph4 study proposals generated in the US Community Oncology practices.
• Review abstracts and/or manuscripts that result from collaborative and RWE studies generated from Community Oncology practices.
• Communicate Gilead’s commitment to scientific excellence through research and education in Community Oncology practices.
• Collaborate effectively and in a compliant manner with colleagues in other functional areas within Gilead.
• Support the development, deployment, and appropriate use of field tools and resources (e.g. slide decks) for the CCC.
• Lead and shepherd oncology medical assets (i.e. field resources) through the Medical Review Committee (MRC) process, in consultation with cross-functional Medical Affairs team members.
• Specific point of contact for the cross-functional field matrix teams within their territory. Work with the matrix team to create a One Oncology approach to our Community Oncology strategy and execution.
• Serves as a CCC resource to the field matrix team and provides training at national and regional levels for medical and commercial colleagues when needed.
• Lead CCC projects/studies based on extensive knowledge base, experience and competency, using a degree of autonomy in the preparation and completion of projects and reports, and by establishing relationships with internal and with external contacts as needed.
• Select sites for participation in the CCC based upon an objective set of criteria.
• Identify and develop relationships with regional and national opinion leaders to support the CCC at Gilead; establish strong relationships with institutional leaders, researchers, and providers in both academic and community settings.
• Anticipates complex obstacles and difficulties that may arise in the field and resolves them in a compliant and collaborative manner.
• Maintains familiarity with all relevant complex scientific data and commits to continuing education to maintain knowledge base.
• Has the ability to work as a member of several teams, such as the MSL and MKAL teams, Key Account Directors (KADs), national accounts, and others.
• Lead relationships with vendors and collaborators on the delivery of materials to include, but not limited to, the CCC Playbook, CCC/SEC Newsletter, CCC Dashboard, and medical communications for the preparation of documents for MRC.
• Contribute, as appropriate, to the development of Global and Local strategic plans and collaborate effectively and compliantly with colleagues in other functional areas throughout Gilead.
• Support CCC efforts and strategic planning for US-based Oncology Societies focused on community engagement in collaboration with the SEC team and other cross-functional leads.
• Other activities, as assigned, to support US Medical Affairs strategy development and tactical execution.
• Adheres to all applicable pharmaceutical codes, Office of Inspector General (OIG) guidelines, and Gilead policies.
• Exhibits Gilead’s core values:Integrity (Doing What’s Right)Teamwork (Working Together)Excellence (Being Your Best)Accountability (Taking Personal Responsibility)Inclusion (Encouraging Diversity)
• Specific point of contact for the cross-functional field matrix teams within their territory. Work with the matrix team to create a One Oncology approach to our Community Oncology strategy and execution.
• Serves as a CCC resource to the field matrix team and provides training at national and regional levels for medical and commercial colleagues when needed.
• Lead CCC projects/studies based on extensive knowledge base, experience and competency, using a degree of autonomy in the preparation and completion of projects and reports, and by establishing relationships with internal and with external contacts as needed.
• Select sites for participation in the CCC based upon an objective set of criteria.
• Identify and develop relationships with regional and national opinion leaders to support the CCC at Gilead; establish strong relationships with institutional leaders, researchers, and providers in both academic and community settings.
• Anticipates complex obstacles and difficulties that may arise in the field and resolves them in a compliant and collaborative manner.
• Maintains familiarity with all relevant complex scientific data and commits to continuing education to maintain knowledge base.
• Has the ability to work as a member of several teams, such as the MSL and MKAL teams, Key Account Directors (KADs), national accounts, and others.
• Lead relationships with vendors and collaborators on the delivery of materials to include, but not limited to, the CCC Playbook, CCC/SEC Newsletter, CCC Dashboard, and medical communications for the preparation of documents for MRC.
• Contribute, as appropriate, to the development of Global and Local strategic plans and collaborate effectively and compliantly with colleagues in other functional areas throughout Gilead.
• Support CCC efforts and strategic planning for US-based Oncology Societies focused on community engagement in collaboration with the SEC team and other cross-functional leads.
• Other activities, as assigned, to support US Medical Affairs strategy development and tactical execution.
• Adheres to all applicable pharmaceutical codes, Office of Inspector General (OIG) guidelines, and Gilead policies.
• Exhibits Gilead’s core values:
• Integrity (Doing What’s Right)
• Teamwork (Working Together)
• Excellence (Being Your Best)
• Inclusion (Encouraging Diversity)

Benefits

• general: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
• general: * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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