CrawlJobs Logo

Clinical Development Director - Oncology

amgen.com Logo

Amgen

Location Icon

Location:
United States

Category Icon
Category:
Research and Development

Job Type Icon

Contract Type:
Employment contract

Salary Icon

Salary:

274788.85 - 371773.15 USD / Year
Save Job
Save Icon
Apply Position

Job Description:

Supporting the development, execution and communication of the global scientific/medical evidence plan. Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program. Supporting the development of key scientific external relationships with opinion leaders. Participating and providing clinical input into safety and regulatory interactions. Provide clinical/scientific input during the development and execution of clinical trials. Interpret clinical trial data. Participate in safety assessments. Participate in interactions with regulatory agencies. Author CSRs, publications and regulatory submissions. Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by Global Development Leader. Identify new clinical research opportunities. Support in-licensing and out-licensing activities and partner relationships. Support product lifecycle management for new indications as directed by Global Development Leader. Provide clinical content input to: Regulatory interactions and documents, Safety interactions and documents, Materials to be used in Scientific Affairs, Materials to be used by the Commercial Organization.

Job Responsibility:

  • Supporting the development, execution and communication of the global scientific/medical evidence plan
  • Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program
  • Supporting the development of key scientific external relationships with opinion leaders
  • Participating and providing clinical input into safety and regulatory interactions
  • Provide clinical/scientific input during the development and execution of clinical trials
  • Interpret clinical trial data
  • Participate in safety assessments
  • Participate in interactions with regulatory agencies
  • Author CSRs, publications and regulatory submissions
  • Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by Global Development Leader
  • Identify new clinical research opportunities
  • Support in-licensing and out-licensing activities and partner relationships
  • Support product lifecycle management for new indications as directed by Global Development Leader
  • Provide clinical content input to: Regulatory interactions and documents, Safety interactions and documents, Materials to be used in Scientific Affairs, Materials to be used by the Commercial Organization

Requirements:

  • MD or DO degree from an accredited medical school
  • 2 years of clinical research experience and/or basic science research
  • 5+ years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities, particularly in GU Oncology (prostate cancer)
  • Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)
  • In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale
  • Familiarity with concepts of clinical research and clinical trial design, including biostatistics
  • Sound scientific and clinical judgment
  • Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements
  • Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication
  • Demonstrated ability as a medical expert in a complex matrix environment
  • History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues

Nice to have:

  • 5+ years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities, particularly in GU Oncology (prostate cancer)
  • Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)
  • In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale
  • Familiarity with concepts of clinical research and clinical trial design, including biostatistics
  • Sound scientific and clinical judgment
  • Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements
  • Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication
  • Demonstrated ability as a medical expert in a complex matrix environment
  • History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues
What we offer:
  • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models where possible

Additional Information:

Job Posted:
May 15, 2026

Employment Type:
Fulltime
Work Type:
Remote work
Icon
Amgen - All Job Offers
Job Link Share:
Copy Link Icon
Facebook Icon Twitter Icon LinkedIn Icon

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for Clinical Development Director - Oncology

Director Business Development - Oncology

Fantastic opportunity to join TFS HealthScience! TFS HealthScience is a leading ...
Location
Location
United States , Boston
Salary
Salary:
Not provided
tfscro.com Logo
TFS HealthScience
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s Degree or equivalent relevant experience
  • Minimum of 5 years of experience in clinical research, business development, or sales within the CRO industry
  • Proven track record of at least 3 years in consultative sales with strong negotiation and closing skills
  • Strong communication skills with the ability to engage and influence clients and stakeholders at all levels
  • Deep understanding of clinical development and the regulatory landscape in the U.S.
  • Strong organizational skills, self-starter, and comfortable working independently in a remote environment
  • Experience with CRM tools and Microsoft Office Suite
  • Excellent presentation and proposal development skills
  • Willingness to travel across North America to attend client meetings, conferences and internal events as needed
Job Responsibility
Job Responsibility
  • Develop and execute a business development strategy focused on the North American biotech/pharma market
  • Drive new business acquisition to meet or exceed annual sales targets
  • Identify and qualify new leads, managing the full sales lifecycle from initial outreach to contract negotiation
  • Collaborate with internal teams to respond to Requests for Information (RFIs) and Requests for Proposals (RFPs)
  • Prepare TFS teams for client engagements, including Capabilities Presentations and Bid Defense Meetings (BDMs)
  • Manage contract and budget discussions post-award to ensure alignment and client satisfaction
  • Establish and maintain strong relationships with prospective and current clients
  • Organize and deliver high-quality sponsor presentations that communicate the value of TFS’ CDS services
  • Provide strategic input and leadership during proposal development
  • Monitor project status post-award and coordinate scope changes as needed
What we offer
What we offer
  • competitive salary and performance-based incentives
  • comprehensive benefits
  • opportunity for personal and professional growth in a rewarding, global environment
  • Remote work flexibility
  • collaborative, mission-driven environment focused on patient outcomes and clinical innovation
  • Fulltime
Read More
Arrow Right

Clinical Genomics Scientist, Oncology

BillionToOne is looking for a Clinical Genomics Scientist, Oncology to help driv...
Location
Location
United States , Menlo Park
Salary
Salary:
158401.00 - 179521.00 USD / Year
billiontoone.com Logo
BillionToOne
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Ph.D. in Human Genetics, M.S. in Genetic Counseling, or related field
  • 2+ years of experience in somatic variant interpretation based on ACMG/AMP guidelines in a clinical setting (alternatively, 1+ years of germline variant interpretation and 1+ years of somatic variant interpretation experience)
  • Hands-on experience working with human mutation databases (COSMIC, ClinVar, OncoKB), functional annotation sources (dbSNP), and genome browsers (UCSC)
  • Familiarity with IGV and BAM file analysis and data-minded willingness to learn to use basic bioinformatics tools, with technically minded insights
  • Knowledge of cancer somatic mutation and signaling pathways (e.g., which mutations have FDA approved drugs, Phase II/III clinical trials, which mutations are considered “hot targets” for drug development, etc.)
  • Exceptional attention to detail to follow highly detailed SOPs and strong organizational skills to track and manage clinical reporting and product improvement projects
  • Excellent communication skills and ability to work collaboratively with cross-functional teams
  • Operationally-defined flexible schedule, including weekends, as dictated by clinical reporting needs
Job Responsibility
Job Responsibility
  • Somatic variant interpretation and data review: Perform somatic-based variant interpretation, diving into the literature and databases to classify variants and match treatments for reporting, performing verification as required with BAM file analysis
  • Clinical report drafting: Carefully draft reports for each requisition primarily using in-house reporting API, working closely with the engineering and QA teams on reporting, and the laboratory directors on report language
  • Somatic mutation interpretation and reporting policy development: Work closely with lab directors, R&D, medical, and other related functions to develop and modify the somatic interpretation SOPs in accordance with ACMG/AMP guidelines, and the latest published literature
  • Content curation: Contribute to curation of gene-level content such as domain and critical residue curation
  • Molecular tumor board: Serve as a subject matter expert in consulting with the medical science liaison team, and presenting in molecular tumor boards to facilitate knowledge sharing
  • Contribute to oncology R&D: Work closely with the R&D team to help with somatic oncology based projects, providing expertise on variant interpretation, biological pathways/mechanisms, and other gene/variant-level reviews and analyses
What we offer
What we offer
  • Working alongside brilliant, kind, passionate and dedicated colleagues, in an empowering environment, toward a global vision, striving for a future in which transformative molecular diagnostics can help millions of patients
  • Open, transparent culture that includes weekly Town Hall meetings
  • The ability to indirectly or directly change the lives of hundreds of thousands patients
  • Multiple medical benefit options
  • employee premiums paid 100% of select plans, dependents covered up to 80%
  • Extremely generous Family Bonding Leave for new parents (16 weeks, paid at 100%)
  • Supplemental fertility benefits coverage
  • Retirement savings program including a 4% Company match
  • Increase paid time off with increased tenure
  • Latest and greatest hardware (laptop, lab equipment, facilities)
  • Fulltime
Read More
Arrow Right

Senior Director, Clinical Development, Oncology

Moderna is seeking an experienced oncology drug developer lead Clinical Developm...
Location
Location
United States , Cambridge, Massachusetts; Princeton, New Jersey
Salary
Salary:
210900.00 - 379200.00 USD / Year
modernatx.com Logo
Moderna
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Medical Doctor (M.D.), Doctor of Osteopathy (D.O.) or non-US equivalent of M.D. degree with relevant hematology and/or oncology in an academic or hospital environment
  • Experience in oncology drug development demonstrated by at least 3 years in the biopharmaceutical industry
  • In exceptional cases, at least 5 years of experience as an early-phase clinical trialist in academia would be considered
  • Medical oncology and/or hematology fellowship training is preferred
  • Experience in oncology and/or hematology immunotherapeutics is preferred
  • Experience in conducting translationally rich oncology and/or hematology clinical trials is highly valued
  • Demonstrated track record in leading cross-functional teams and work streams (e.g., translational medicine, biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences)
  • Outstanding verbal and written communication skills, in addition to excellent organizational skills
  • Understanding of the entire drug development process, including clinical and non-clinical study design and execution
  • Thorough understanding of clinical research methodology and biostatistics principles, to facilitate innovative and efficient clinical trial design, and clinical development plans with clear data-driven decision rules
Job Responsibility
Job Responsibility
  • Collaborate in the development and execution of the Clinical Development Plan (CDP) for assigned oncology assets
  • Integrates scientific rationale, regulatory requirements, product development plan and commercial goals to optimize clinical study designs aligned with the Integrated Development Plan (IDP) and CDP
  • Generates data and evidence required to determine a medicine’s potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe
  • Establishes expeditious clinical development timelines, incorporating key decision points and Go/No Go criteria for the CDP
  • Collaborate effectively with program counterparts in Translational Medicine, Pharmacometrics, Research, Biostatistics, Clinical Operations, Regulatory, Commercial, and other functional areas as needed
  • Contributes to and partners with the development of strategic initiatives, such as organizational initiatives within Clinical Development
  • Plays an active role in the technical and leadership development of Clinical Scientists
  • Employs visioning and strategic thinking to provide expert leadership of disease/therapeutic area specific strategy for a drug(s) or program(s)
  • Leads selected clinical development projects for products/franchise of compounds
  • Able to lead and influence across a diverse range of scientific external experts (e.g. regulators, payors, CROs, consultants, investigators) in order to deliver integrated clinical development strategy, which align to the business strategy and achieves mutual goals related to patient need
What we offer
What we offer
  • Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
  • A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
  • Family planning benefits, including fertility, adoption, and surrogacy support
  • Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
  • Savings and investment opportunities to help you plan for the future
  • Location-specific perks and extras
  • Eligible for an annual discretionary bonus, other incentive compensation, or equity award
  • Fulltime
Read More
Arrow Right

Senior Medical Director, Late Development, Breast Oncology

This position is for a Senior Medical Director within the atirmociclib program. ...
Location
Location
United States , New York City; La Jolla; Cambridge; Bothell; Groton
Salary
Salary:
274500.00 - 444100.00 USD / Year
pfizer.de Logo
Pfizer
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Medical degree with 5+ years of industry experience
  • Clinical oncology experience (typically 4+ years)
  • Board certified/eligible in oncology or equivalent preferred
  • Breast Oncology experience (2+ years)
  • Ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact
  • Permanent work authorization in the United States
Job Responsibility
Job Responsibility
  • Clinical Development Leadership on Study Teams and Development Subteams
  • Conduct medical monitoring activities including eligibility assessment, data review and safety monitoring
  • Lead peer-to-peer interactions with investigators
  • Serve as the point of contact for clinical issues between the study team, investigators, ethics committees, steering committees, and regulatory authorities
  • Lead and contribute to development and maintenance of clinical trial and regulatory documents, in collaboration with Clinical Scientist and the cross-functional team
  • Provide clinical development leadership across several study teams
  • Serve as the Clinical Development Lead on subteams including for Marketing Authorization Applications
  • Strategic Guidance, Clinical Insights & Interpretation
  • Collaborate with the Global Development Team to create and refine development strategies
  • Represent the company in external engagements or as committee member in joint collaborations
What we offer
What we offer
  • Participation in Pfizer’s Global Performance Plan with a bonus target of 25.0% of the base salary
  • Eligibility to participate in our share based long term incentive program
  • 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
  • Paid vacation, holiday and personal days
  • Paid caregiver/parental and medical leave
  • Health benefits to include medical, prescription drug, dental and vision coverage
  • Relocation support available
  • Fulltime
Read More
Arrow Right

Associate Medical Director

Associate Medical Director, Oncology. ICON plc is a world-leading healthcare int...
Location
Location
Poland , Warsaw
Salary
Salary:
Not provided
iconplc.com Logo
iconplc
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Medical degree (MD) required
  • Board certification preferred in oncology/haematology
  • Minimum of 3 years of experience in clinical research or medical affairs within the pharmaceutical or biotechnology industry
  • Strong understanding of clinical trial design, execution, and regulatory requirements
  • Experience in immune oncology
  • Excellent communication and relational skills
  • Demonstrated leadership and problem-solving abilities
Job Responsibility
Job Responsibility
  • Collaborating with cross-functional teams to design clinical development plans and study protocols
  • Providing medical oversight and guidance throughout the lifecycle of clinical trials
  • Ongoing medical review of data, supporting Safety Review Committees
  • Interpreting complex medical and clinical trial data to support decision-making and regulatory submissions
  • Contributing to the development of scientific publications, presentations, and regulatory documents
  • Building and maintaining relationships with investigators, key opinion leaders and regulatory authorities
What we offer
What we offer
  • Various annual leave entitlements
  • A range of health insurance offerings
  • Competitive retirement planning offerings
  • Global Employee Assistance Programme, LifeWorks
  • Life assurance
  • Flexible country-specific optional benefits
Read More
Arrow Right

Clinical Scientist Director, Late Development GU Oncology

In this vital role, the Clinical Scientist Director will support late-phase clin...
Location
Location
Portugal , Lisbon
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Doctorate degree and 4 years of life sciences/healthcare experience
  • Master’s degree and 7 years of life sciences/healthcare experience
  • Bachelor’s degree and 9 years of life sciences/healthcare experience
  • 5 years of pharmaceutical clinical drug development experience
  • Industry experience in late-phase drug development for oncology (prostate-specific experience is a plus)
  • Strong communication & presentation skills
  • Experience with designing, monitoring, and implementing clinical trials for oncology and interpreting test results in compliance with Good Clinical Practice standards and regulatory requirements
  • Understanding of conducting study data readout activities
  • Experience drafting high level submission documents for regulatory submissions
  • Serving as a contributing author to scientific publications and data presentations at scientific conferences
Job Responsibility
Job Responsibility
  • Support late-phase clinical development by translating scientific and clinical strategy into actionable execution across clinical trials
  • Serve as a key clinical development team member
  • Provide hands-on oversight of protocol execution, medical data review, and clinical data quality
  • Serve as a clinical and scientific subject-matter expert for the assigned therapeutic area and disease indication
  • Contribute to medical monitoring activities and support ongoing assessment of subject-level clinical data
  • Present information internally and externally
  • Provide guidance and assistance in the identification and management of collaborators, consultants, and/or Clinical Research Organizations (CROs)
  • Work cross functionally to ensure clinical strategy is translated into the development of the study concept document, study protocol, and related documents
  • Ensure integrity of protocols and/or components of clinical plans and for the delivery of final protocol and its governance approval
  • Provide clinical input into & implementation of clinical trial(s), delivery, clinical data review, and interpretation of results
What we offer
What we offer
  • Vast opportunities to learn, develop, and move up and across our global organization
  • Diverse and inclusive community of belonging
  • Generous AMGEN Total Rewards Plan comprising healthcare, finance, wealth, and career benefits
  • Flexible work arrangements
  • Fulltime
Read More
Arrow Right

Clinical Scientist Director – Early Development, Oncology

In this vital role, the Clinical Scientist Director will support early phase cli...
Location
Location
Portugal , Lisbon
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Doctorate degree and 4 years of life sciences/healthcare experience
  • Master’s degree and 7 years of life sciences/healthcare experience
  • Bachelor’s degree and 9 years of life sciences/healthcare experience
  • 5 years of pharmaceutical clinical drug development experience
  • Industry or academic experience in early-phase drug development within Oncology
  • Strong communication & presentation skills in English
  • Experience with designing, monitoring, and implementing clinical trials for Oncology and interpreting test results in compliance with Good Clinical Practice standards and regulatory requirements
  • Understanding of conducting study data readout activities, including data cleaning, database lock, data extract, producing outputs of data
  • Experience drafting high level submission documents for regulatory submissions including authoring clinical regulatory responses for health regulatory interactions
  • Serving as a contributing author to scientific publications and data presentations at scientific conferences
Job Responsibility
Job Responsibility
  • Serve as a clinical and scientific subject-matter expert for the assigned therapeutic area and disease indication, with a strong focus on protocol execution and data integrity
  • Contribute to medical monitoring activities and support ongoing assessment of subject-level clinical data to identify trends, risks, and emerging issues
  • Present information internally and externally, anticipating and actively managing problems across a broad spectrum of cross-functional teams
  • Provide guidance and assistance in the identification and management of collaborators, consultants, and/or Clinical Research Organizations (CROs) in completion of key projects
  • Work cross functionally to ensure clinical strategy is translated into the development of the study concept document, study protocol and related documents
  • Ensure integrity of protocols and/or components of clinical plans and for the delivery of final protocol and its governance approval
  • Provide clinical input into & implementation of clinical trial(s), their delivery, clinical data review, interpretation of results
  • Review and analyze clinical trial data to ensure accuracy, completeness and adherence to protocol and regulatory requirements
  • Conduct thorough data quality assessments in the context of a data monitoring plan to maintain high standards of data accuracy and integrity throughout the trial lifecycle
What we offer
What we offer
  • Vast opportunities to learn, develop, and move up and across our global organization
  • Diverse and inclusive community of belonging, where colleagues are empowered to bring ideas to the table, take risks, and act
  • Generous AMGEN Total Rewards Plan comprising healthcare, finance, wealth, and career benefits
  • Flexible work arrangements
Read More
Arrow Right

Medical Director, Hematology

Lead the science that shapes tomorrow's hematology breakthroughs. Proclinical is...
Location
Location
United States , Boston
Salary
Salary:
Not provided
proclinical.com Logo
Proclinical
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Medical degree (MD or equivalent), ideally with Hematology/Oncology fellowship training
  • Strong interest in developing innovative therapies and impacting patient populations
  • Experience in clinical research or drug development, spanning Phases I through IV, is preferred
  • Medical and scientific expertise in hematology or oncology is advantageous
  • Excellent collaboration and communication skills to work effectively with diverse teams and stakeholders
Job Responsibility
Job Responsibility
  • Lead clinical deliverables for a designated section of a clinical program with minimal supervision
  • Manage operational aspects and ensure successful execution of the clinical program in partnership with global line functions, Clinical Scientists, and Clinical Operations teams
  • Support and occasionally lead interactions with external collaborators, including regulatory authorities, key opinion leaders, advisory boards, and patient advocacy groups
  • Collaborate with internal teams such as Research, Early Clinical Development, Medical Affairs, Marketing, and HEOR
  • Contribute to Global Clinical Development training programs, author or review clinical SOPs, and participate in taskforces or panels to shape clinical development strategies
Read More
Arrow Right