1,479 Results for

Associate Director Jobs in New Jersey

Jobs

Cybersecurity Technical Writer Associate Director Kforce Inc.

Jersey City, NJ

$55–$59

Partner with cybersecurity subject matter experts to capture technical workflows, identify documentation gaps, and ensure procedures reflect current operating practices. Working knowledge of cybersecurity operations such as incident response, penetration testing, red teaming, threat hunting, insider risk, and vulnerability management.

2 days ago

Associate Director, Regulatory Writing Daiichi Sankyo, Inc.

Basking Ridge, NJ

$157,920–$236,880 / year
Full time

The Associate Director, Regulatory Writing must possess advanced knowledge of BLA/MAA submissions, working knowledge and experience in document management systems, relevant therapeutic areas, regulatory requirements, and other aspects of drug development (eg, nonclinical, pharmacokinetics, biostatistics). 4+ years of experience as a medical writer with a graduate degree (Doctorate preferred) in a relevant science field or 7+ years of experience as a medical writer with a Bachelor's degree in a relevant science field required.

12 days ago

Associate Director, US Medical Affairs Training Daiichi Sankyo, Inc.

Basking Ridge, NJ

$188,640–$282,960 / year
Full time

The Associate Director, US Medical Training & Development will be responsible for ensuring Medical Affairs Teams and contingent workers have the skills and knowledge to perform effectively by developing, delivering, evaluating, and documenting training programs, including on-boarding, leadership development, therapeutic area training, skills training, and ongoing curriculum management. Primary responsibilities include: Creating and maintaining training programs for new hires and existing team members, collaborating with to align content with business goals, and transforming clinical and product information into clear, engaging training materials.

9 days ago

Associate Director, Regulatory Affairs Advertising and Promotion Daiichi Sankyo, Inc.

Basking Ridge, NJ

$166,720–$250,080 / year
Full time

The Associate Director, Regulatory Affairs Advertising and Promotion (RAAP) provides strategic and tactical regulatory support for U.S. promotional and selected non-promotional communications across assigned products, disease-state initiatives, and related external-facing materials within the Daiichi Sankyo portfolio. Partner with Medical, Legal, Compliance, Commercial, Clinical, Labeling, Public Affairs, Corporate Communications, Market Access, including alliance partners to support aligned, efficient, and compliant review of promotional materials.

30+ days ago

Associate Director, Consumer US Marketing Daiichi Sankyo, Inc.

Basking Ridge, NJ

$162,400–$243,600 / year
Full time

With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

30+ days ago

Associate Director, US Medical Research & Strategy Daiichi Sankyo, Inc.

Basking Ridge, NJ

$162,400–$243,600 / year
Full time

Manages budgets and vendor/agency activities as needed and provides regular reporting on budget and financial metrics Aligns Medical Affairs activities with the overall Tumor Strategy and/or Brand Management plan including cross-functional deliverables jointly owned by departments such as Marketing and Market Access. The Associate Director will provide program management support across all the Medical Affairs functions that are working on a launch, approved products or earlier assets to assure consistent planning, execution, tracking and reporting of activities in accordance with Medical Affairs strategy and objectives.

30+ days ago

Associate Director, Companion Diagnostics Leader Daiichi Sankyo, Inc.

Basking Ridge, NJ

$166,720–$250,080 / year
Full time

Contributes to CDx project teams for the diagnostic, under the direction of the Global Program Teams (GPT) CDx representative for the therapeutic or under the guidance of the CDx portfolio leader, covering all areas from CDx assay development through CDx approval and launch. Provides scientific and technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads and Regulatory Liaisons to ensure successful implementation of CDx and data collection.

30+ days ago

Associate Director, Biostatistics (Late Stage Oncology) Daiichi Sankyo, Inc.

Basking Ridge, NJ

$175,440–$263,160 / year
Full time

Protocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies including study design, protocol development, CRF review, SAP development, analysis files development, statistical analysis accuracy validation, results interpretation and CSR input and review. Global BDO Strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex initiatives, with some level of supervision, to improve the harmonization and efficiency of drug development which leads to cost savings and shortened timelines for the company.

30+ days ago

Associate Director, US Clinical Supply Business Management, GCSO Daiichi Sankyo, Inc.

Basking Ridge, NJ

$162,400–$243,600 / year
Full time

Additionally, the role will serve as a key member of the Global Clinical Supply Committee (GCSOC), providing the Project Management Office (PMO) support in organizing and facilitating Committee meetings and ensuring progress is achieved with other Committee members continuously. This role is accountable to the Head, Clinical Supply & Business Management - Global Clinical Supply Operations (GCSO) to drive the vision and implementation of the Business Management function in the US (DSI) through close collaboration with Global Business Management colleagues in Japan and Germany.

29 days ago

Associate Director, Clinical Data Management Genmab

Princeton, NJ

Ensure procedures for blinding are in place where applicable - Support timely delivery of data management deliverables in accordance with Genmab SOP and ICH/GCP - Attend trial and investigator/monitor meetings as needed - Participate in definition, review and approval of data packages for Data Monitoring Committee’s, if applicable - Review and approve any corrections and updates of data packages, if applicable - Support timely development, update and maintenance of dashboards, if applicable - CRO selection and collaboration: - Support vendor qualification (Request for proposal, bid defense meetings etc.) in terms of Data management, ePRO and IRT related activities and define/specify scope of work for functional tasks - Review scope of work in a given trial in collaboration with relevant stakeholders and review/challenge major work orders (WOs)/change orders (COs)/change notification forms (CNFs) - Attend operational committee meetings, as applicable - Compliance: - Ensure compliance with relevant regulations, Genmab SOPs and ICH GCP - Ensure escalations are made as appropriate to secure proper progress and quality of the trial - Ensure compliance with Genmab Code of Business Ethics - Ensure that the trial oversight activities are conducted in accordance with the trial oversight plan, e.g. providing listings and documentation - Lead/contribute with knowledge sharing within the department - Follow scientific, process and technical progress within the field of data management in drug development and advise of new methodologies that may support innovation and improve efficiencies - Contribute on processes optimizations and SOP revisions - Lead cross-functional working groups/projects/task forces or new IT tools & technology implementation Competencies The Employee must have competences within the following areas: - - Project Management - Planning and organization - Clinical development/trial conduct, including ICH-GCP - Team leadership - Excellent communication skills and able to communicate scientific communication in clear and concise manner - Problem solving and decision making - Quality mindset - Document creation and management - Process development - Proactive and Accountable - Analytical and ability to interpret and present clinical data - IT skills Requirements Bachelor's degree in science or related area (or equivalent) 10 years of experience in clinical data management experience in biotech/ pharma industry; significant hands-on experience in all aspects of data management.

Today

Associate Director, Clinical Science Daiichi Sankyo, Inc.

Basking Ridge, NJ

$162,400–$243,600 / year
Full time

Under supervision of Clinical Science Asset Lead or Clinical Science Lead, drafts development plans, protocol profiles, protocols, informed consent forms, and sections of submission documents. Advanced Technical Expertise: Possess advanced understanding of pre-clinical and clinical research, including protocol writing, data review, study design, and disease area knowledge preferred.

30+ days ago

Associate Director Biostatistics, Early Phase Daiichi Sankyo, Inc.

Basking Ridge, NJ

$175,440–$263,160 / year
Full time

Protocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex early phase studies, including dose-escalation, dose-expansion, and dose-optimization design; protocol development; CRF review; SAP and analysis specification development; statistical analysis quality review; results interpretation; and CSR input and review. Provides statistical guidance to study and project teams and contributes to the evaluation and integration of emerging safety, tolerability, efficacy, pharmacokinetic/pharmacodynamic, and biomarker data to support dose escalation, dose selection, cohort expansion, and development decisions; collaborates closely with data management and statistical programming to ensure high-quality data and outputs.

24 days ago

Associate Director, Oncology Account Management - NJ Daiichi Sankyo, Inc.

Basking Ridge, NJ

$174,880–$262,320 / year
Full time

This includes a primary focus on regional payers and OHS, pharmacy and medical department relations and contracts; also includes ability to build relationships outside of pharmacy to obtain payer insights/knowledge and identify potential opportunities (disease state management; network strategies; quality departments, health care exchanges; patient center medical home; accountable care focus, etc). Using a deep understanding of payer and provider economics and an account based selling approach, the team delivers solutions for customers and patients Account Managers develops collaborative partnerships with both internal and external stakeholders (specialty GPO customers, SAMs, field sales, field medical, and other key functional areas) to drive contract success.

30+ days ago

Associate Director, Business Insights & Analytics - Head & Neck Oncology Genmab

Plainsboro, NJ

For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.5c143e31-5e48-4549-b638-05792d185386

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Associate Director, Trial Delivery Team Lead Genmab

Princeton, NJ

Requirements – what you must have - Bachelor of science degree with relevant specialization; Master of science degree preferred - Minimum requirement of 12 or more years of experience in clinical operations - Significant experience in leading and managing complex global clinical projects/programs - Significant experience managing/guiding internal (cross-functional) and external (CRO, regulatory authorities) teams - Experience with operational management and budget planning - Proven performance in earlier role/comparable role - Global clinical program level experience required - Experience within the field of oncology is preferred - Minimum 2 years’ experience as Clinical Operations representative in Clinical Development Teams (CDTs) or Global Project Teams (GPTs) would be preferable - Experience leading team members in global matrix environment, leveraging tools and technology to ensure business needs are met. - Strategic thinking with ability to optimize organizational resources for successful program execution - Excellent communication skills in English, both written and spoken Moreover, you meet the following personal requirements: - Dedicated team player who enjoys leading teams and inspire trust among colleagues - Quality mindset and able to prioritize your work in a fast paced and changing environment - Result- and goal-oriented and committed to contributing to the overall success of Genmab For US based candidates, the proposed salary band for this position is as follows: $158,720.00$238,080.00 The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location.

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Associate Director - External Data Acquisition Lead (EDAL) Genmab

United States (Remote), NJ

Remote

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Associate Director, Medical Information (Medical Review - Oncology) Genmab

Plainsboro, NJ

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Associate Director, R&D Strategic Initiatives Genmab

Plainsboro, NJ

Project Management certification is a plus • At least 8 years of experience in biotech/pharma or related industry with 3 years in project management • Experience of working in cross-functional environment • Proven track record in project management, demonstrating the ability to effectively plan, execute, and deliver complex R&D projects • Demonstrated experience leading enterprise or cross-functional initiatives in a matrix environment, influencing stakeholders and driving alignment without direct authority. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies.

Today

Associate Director, Business Insights and Analytics Genmab

Plainsboro, NJ

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Associate Director, Biostatistics Genmab

Plainsboro, NJ

Today

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Associate Director Jobs in New Jersey

Cybersecurity Technical Writer Associate Director Kforce Inc.

Associate Director, Regulatory Writing Daiichi Sankyo, Inc.

Associate Director, US Medical Affairs Training Daiichi Sankyo, Inc.

Associate Director, Regulatory Affairs Advertising and Promotion Daiichi Sankyo, Inc.

Associate Director, Consumer US Marketing Daiichi Sankyo, Inc.

Associate Director, US Medical Research & Strategy Daiichi Sankyo, Inc.

Associate Director, Companion Diagnostics Leader Daiichi Sankyo, Inc.

Associate Director, Biostatistics (Late Stage Oncology) Daiichi Sankyo, Inc.

Associate Director, US Clinical Supply Business Management, GCSO Daiichi Sankyo, Inc.

Associate Director, Clinical Data Management Genmab

Associate Director, Clinical Science Daiichi Sankyo, Inc.

Associate Director Biostatistics, Early Phase Daiichi Sankyo, Inc.

Associate Director, Oncology Account Management - NJ Daiichi Sankyo, Inc.

Associate Director, Business Insights & Analytics - Head & Neck Oncology Genmab

Associate Director, Trial Delivery Team Lead Genmab

Associate Director - External Data Acquisition Lead (EDAL) Genmab

Associate Director, Medical Information (Medical Review - Oncology) Genmab

Associate Director, R&D Strategic Initiatives Genmab

Associate Director, Business Insights and Analytics Genmab

Associate Director, Biostatistics Genmab

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