Senior Manager Field Training East jobs at Incyte

Job Summary (Primary function)
The Sr. Biologics CMC (Chemistry, Manufacturing, and Controls) Writer will be primarily responsible for authoring CMC sections of global regulatory submissions including BLA, IND, IMPD, MAA as well as working with other technical documents (e.g.. Redlining/SOC reports). The position will manage work independently with members of the Biologics Pharmaceutical Development group as well as other functional areas within the organization, including external collaborators, to complete the full package ready for submission.

Essential Functions of the Job (Key responsibilities)

• Contribute to the phase appropriate development strategy for the Biologics portfolio.
• Write and edit CMC sections of Regulatory documents that are submitted to Regulatory Agencies worldwide. Experience with authoring Module 3 CTD sections for IND and BLA is highly desirable.
• Collaborate with subject matter experts to write and edit other manufacturing related controlled technical documents using a uniform style and language for regulatory compliance.
• Coordinate authoring and review activities with the functional areas within Global Biopharmaceutical Development and Quality Assurance to reach alignment and to meet deadlines for Regulatory Submissions.
• Work closely with Regulatory Affairs to establish priorities and ensure successful completion of regulatory submissions to Regulatory Operations.

Qualifications (Minimal acceptable level of education, work experience, and competency)

• Degree (such as BS/MS/PhD) in Engineering or Biological Sciences or equivalent experience and in the biotech related industry.
• Several years of experience in Biologics technical writing as a SME in Analytical, Formulation, or Process Sciences, in authoring CMC sections of global regulatory filings.
• Technical knowledge of and experience in monoclonal antibody development is a plus.
• Experience with working collaboratively with other departments such as technical teams, Quality Assurance and Regulatory Affairs.
• Proven track record on regulatory submissions of biological products.
• Demonstrate competency in clear and concise technical writing ability.
• Must be well organized, flexible, with excellent cross-functional communication skills that encourages inclusion and welcomes diversity of thought among stakeholders.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

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During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .

Job Summary

·Participate in internal site contract efficiency improvement initiatives

·For assigned sites, serve as a primary site contract contact for country/regional end-to-end study site contract activity

·Participate in all assigned Study Site Management study team meetings, providing cross-functional teams with detailed updates related to site contract activity

·Utilize systems and tools to track assigned activities and produce reports and metrics as needed

·Responsible for site contract collection, tracking & review

·Responsible for the collection of country and site level intelligence

·Where required, complete, manage and/or support country/region and site-specific site contract activities (e.g., electronic medical record access agreements, site payment activities, budget escalations) required to activate or maintain sites for a study as appropriate

·Other duties as assigned

Minimum Requirements

·Preferred Bachelor’s Degree in Business Administration, science or related field or work experience equivalent

·Minimum of three years of relevant experience in site contracts and/or payments

·Ability to negotiate intermediate contract and payment terms

·Flexibility to assume a workload which frequently necessitates an adjustment of priorities

·Goal oriented, self-starter with proven ability to work independently

·Able to proactively identify issues and provide potential solutions for resolution

·Detail oriented

·Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines

·Proficiency with all applications of Microsoft Office

·Good interpersonal skills

·Comfort with ambiguity; ability to act without having the total picture

·Excellent oral and written communication skills in English and other local language(s) as applicable

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

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During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .

Job Summary:

Responsibilities:

Develop and implement the overall training strategy for Oncology Sales, Marketing, and Market Access ensuring alignment with business objectives and market evolution.

Design, deliver, and manage all aspects of the Oncology Sales, Marketing, and Market Access and Business Operations training curriculum, including new hire onboarding, product launches, disease state education, and ongoing professional and leadership development.

Hire, lead, and develop a high-performing training team responsible for the creation and delivery of training programs.

Partner with Medical, Legal, Regulatory, and Commercial teams to ensure all training materials are accurate, compliant, and up-to-date.

Establish and maintain the LMS to roll out, track, and report on all training activities for the Oncology commercial organization.

Oversee the training budget, optimizing the use of internal and external resources to maximize impact and efficiency.

Regularly assess training effectiveness and implement improvements based on feedback, business needs, and market changes.

Develop and deliver programs focused on both sales effectiveness and leadership capabilities within the Oncology commercial team.

Ensure all training content reflects the latest developments in oncology, including key brands and emerging products.

Submit all training materials through the Medical, Legal, and Regulatory (MLR) review process to ensure compliance with industry standards.

Qualifications:

Bachelor’s degree required; advanced degree or relevant certifications preferred.

Significant years’ experience in leadership development, talent management, or organizational effectiveness

Extensive experience in pharmaceutical/biotechnology industry, with a strong preference for oncology/hematology market knowledge.

Proven track record in Sales and/or Marketing training and development, including leadership roles.

Experience with adult learning principles, instructional design, and e-learning technologies.

Strong organizational, communication, and leadership skills.

Proficiency in Microsoft Office Suite (Word, PowerPoint, Excel, Access).

Ability to manage multiple projects and priorities in a fast-paced environment.

Demonstrated ability to collaborate cross-functionally and influence without authority.

Willingness and ability to travel (15-20%)

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Learn more at:

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .

Job Summary (Primary function)

Essential Functions of the Job (Key responsibilities)

Designs and implements a training plan in alignment with Dermatology/IAI Medical strategic goals and objectives with input from appropriate subject matter experts to support the scientific and non-medical training needs of the Medical team

Creates scientific training materials, including clinical Q&As, product/disease state backgrounders, and slide decks

Supports the creation and maintenance of an internal LMS platform, including access, content, and routine updates

Assesses effectiveness of training program and identifies skill gaps; ensures implementation of innovative training initiatives that effectively address these issues

Formulates training curriculum for new field Medical hires and assists field leadership in establishing expectations and the certification process. Provides hands-on coaching to support both new hire and ongoing strategic education

Ensures that appropriate employee assessments are in place and conducted on a regular basis through routine field visits (~10 per year) and communicates feedback and recommendations to field leadership

Partners with leadership to implement soft-skills trainings to develop leadership and business acumen of Medical Affairs personnel to achieve the technical, medical, and interpersonal competencies of their roles

Sources, evaluates, and selects vendors to implement robust and cost-effective training courses, and leads development of agendas for training programs in Medical Affairs as required

Leads cross functional competitive readiness activities, including maintaining current competitive landscape documents and organizing pre- and post-conference training. Collaborates with field Medical on monthly journal clubs and competitive insights reporting

Ensures the appropriate documentation and tracking of training activities to ensure all legal, regulatory, and compliance requirements are met

Qualifications (Minimal acceptable level of education, work experience, and competency)

Qualified candidates will have advanced degrees (MD, PharmD, PhD) with a minimum of 5 years’ Medical Affairs experience within the pharmaceutical industry. Prior experience as MSL or Medical Trainer is strongly preferred

Knowledge/familiarity with dermatologic/immunologic conditions is preferred

Certification in education and knowledge of adult learning principles, including the ability to appraise needs, problem-solve and select alternative methods to support a variety of learning styles is strongly desired

Excellent written, verbal, presentation, interpersonal communication, and leadership skills

Flexible, with a positive attitude, strong ability to multitask, prioritize projects effectively and communicate at all levels within the company

Strong negotiation, strategic influencing, and planning skills. Must demonstrate initiative, project management skills, analytical and critical thinking skills

Proven ability to perform successfully under stringent timelines while delivering desired results

Excellent computer skills: Excel, Word, Power Point, Microsoft, Outlook/Office

Ability to collaborate with multidisciplinary teams to ensure the execution of deliverables successfully

Ability to work as a collaborative team member in a dynamic environment

Must be knowledgeable on pharmaceutical regulations (PhRMA), guidelines (ACCME, OIG, FDA) ensuring consistent best practices across all activities

Up to 20% of domestic travel required, including field visits

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Learn more at:

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .

Essential Functions of the Job (Key responsibilities):

• Oversee, develop, and maintain written scientific information for use in responding to unsolicited customer requests; explore opportunities to leverage AI solutions.
o Manage external vendors involved in scientific content development.
• Creation of medical information standard response letters, product dossiers, and frequently asked question (FAQ) documents
• Serve as an active member on cross-functional teams (e.g., promotional materials review committee, core medical team, scientific materials review committee).
• Provide medical literature surveillance for Medical Affairs; communicate pertinent updates in a timely manner.
• Support medical conference activities, including execution of pre- and post-conference deliverables, insights generation, and staffing of medical/scientific booth.
• Collaborate with cross-functional partners (eg, Research & Development, Publications & Medical Communications); assist with development of scientific exchange materials for emerging therapeutic areas.
• Develop and maintain expertise in relevant hematology and oncology therapeutic areas, including disease states, treatment landscape, and ongoing research strategies.
• Assist Medical Information Leadership with key projects, as needed.
• Comply with all guidelines, policies, legal, regulatory, and compliance requirements.

Qualifications (Minimal acceptable level of education, work experience, and competency):

• Healthcare Professional (PharmD, MD, RPh, PhD in related field) with 2-5 years' experience working in a Medical Information/Medical Affairs capacity for a pharmaceutical or medical device company, or equivalent clinical experience, is required.
• Knowledge of FDA regulations regarding the dissemination of Medical Information, drug promotion, and adverse event and product quality complaint reporting, is required.
• Experience creating scientific content, including medical information response letters and clinical slide presentations, is required.
• Ability to query scientific literature (via PubMed, Embase, Scopus, etc.) and identify and summarize pertinent findings is required.
• Excellent oral and written communication skills are required.
• Excellent project management skills, including the ability to plan, prioritize, and execute multiple projects are required.
• Experience in hematology/oncology is strongly preferred.
• Approximately 15% travel commitments.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Learn more at:

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .

Job Summary:
. This role will ensure KAM executional excellence.

Responsibilities:

Drive enterprise-level strategyfor engagement with top-tier regional oncology accounts—including NCI-designated centers, IDNs, GPO-affiliated networks, and regional cancer ecosystems—to optimize product access, accelerate treatment adoption, and deliver sustainable value across the oncology portfolio.

Cultivate and expand executive-level relationships

Oversee national account intelligence and segmentation, guiding deep profiling initiatives to uncover institutional protocols, reimbursement dynamics, payer landscapes, and decision-making hierarchies that inform targeted access strategies and resource deployment.

Lead the development and execution of integrated account strategies

, translating national contracting and access strategies into localized execution plans, while providing actionable insights to inform broader policy, pricing, and partnership decisions.

Elevate stakeholder engagements ensuring

Qualifications:

Bachelor’s degree required; advanced degree or relevant certifications preferred.

Significant experience in the pharmaceutical/biotech industry, including Oncology experience required.

Demonstrated clinical engagement and pull-through, communicating clinical and economic value to pharmacy and therapeutic area leaders.

In-depth local market knowledge, including referral patterns, infusion practices, and site-level operational levers.

Excellent communication, negotiation, and relationship-building skills.

Strong analytical skills

Proficiency in Microsoft Office Suite (Word, PowerPoint, Excel).

Willingness and ability to travel frequently (50%+).

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Learn more at:

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .

Job Summary :

The Senior Director, US Medical Affairs (USMA) Training and Medical Excellence designs, delivers, and evaluates departmental training programs and oversees the development and implementation of strategies to enhance Medical Affairs effectiveness in executing departmental activities. This includes identifying and evaluating USMA key performance indicators related to USMA strategy and external engagements plans, coordinating and evaluating launch readiness activities, and developing the digital strategic plan related to omnichannel and AI activities for the department.

Essential Functions of the Job:

Creates the USMA training plan, in collaboration with key USMA stakeholders (e.g. Scientific/Medical Directors, Medical Information & Content Development, MSL leadership) for each product and therapeutic area in alignment with department strategic plans

Creates and implements foundational clinical training (e.g. Statistics, Fundamentals of oncology) for USMA team to supplement core training plan areas of focus

Identifies and implements essential skill training for USMA team members, including leveraging coursework utilized by other training functions in US organization.

Implements and monitors use of the learning management system (LMS) by USMA team members to optimize training content, cadence, and quality

Conducts field visits with MSLs to ascertain effectiveness of training program and identifies and addresses areas of individual need

Collaborates with USMA stakeholders to develop and track key performance indicators to measure and optimize Medical Affairs activities with emphasis in areas of external engagement and scientific communication

Analyzes department engagement insights in collaboration with MSL leadership and Scientific/Medical Directors to inform training needs and contribute to overall external engagement strategy

Collaborate with USMA stakeholders and IT partners to optimize USMA system integration in areas of external engagement

Collaborate with cross-functional partners to develop and monitor launch readiness efforts, including external engagement and scientific communication

Develops and manages the digital strategic plan to support improvements in field medical team effectiveness and efficiency including, but not limited to, the evolution of digital tools, developing advanced analytics, omnichannel approaches, and integration of artificial intelligence

Works collaboratively with key stakeholders within US Medical Affairs, Business Operations, the AI Institute, and other relevant departments to ensure robust sharing of ideas and optimal alignment across digital initiatives

Qualifications (Minimal acceptable level of education, work experience, and competency):

Advanced degree (MD, PharmD, PhD)

Experience in managing high-performing teams

Experience in Oncology Medical Affairs or other relevant experience is strongly preferred

Knowledge of adult learning principles, ability to appraise needs, solve problems, and support a variety of learning styles

Strong understanding of generative AI, omnichannel approaches, digital tools, and digital analytics

Excellent written, verbal, presentation, interpersonal communication, and leadership skills

Ability to work collaboratively within a dynamic team environment to ensure successful execution of deliverables

Strong business acumen, vision, and perspective

Strong project management, analytical, and problem-solving skills

Up to 50-60% domestic travel is required

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Learn more at:

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .