Director, Clinical Pharmacology Job at Life Science Talent

Director, Clinical Pharmacology

The role is positioned in the Clinical Pharmacology group, Clinical and Quantita...

Location

United States , Cambridge

Salary:

167000.00 - 300700.00 USD / Year

Moderna

Expiration Date

Until further notice

Requirements

PhD and/or PharmD in Clinical Pharmacology, Pharmacometrics, Pharmaceutics, Statistics, Engineering, or a related field with a minimum of 8-10 years of industry experience in clinical pharmacology
In depth knowledge of clinical pharmacology, PK/PD principles, modeling and simulation, ADME and quantitative translational sciences
Hands-on quantitative skills, modeling expertise and familiarity with clinical operations and translational sciences
Sound knowledge of drug regulatory authority biopharmaceutics and clinical pharmacology requirements to support the clinical development and marketing of new drug products
Drug development experience in oncology and rare diseases preferred
expertise in immune therapeutics and/or infectious diseases is a plus
Platform expertise in mRNA therapeutics, and/or experience with biologics and new modalities preferred
Demonstrated ability to work independently, lead functional initiatives, adapt quickly and collaborate effectively in a highly dynamic environment and influence cross-functional teams
Proficient in using pharmacokinetic, modeling and data visualization software (e.g. Phoenix WinNonlin, R, Monolix, NONMEM, etc)
Outstanding verbal and written communication skills, with the ability to distill complex data for diverse audiences

Job Responsibility

Develop a fit-for-purpose Clinical Pharmacology development plan, including dose selection and optimization, evaluation plan for special populations, PK/PD and immunogenicity assessment, and pediatric development
Collaborate with program teams to develop dose selection strategy and support decision makings for first-in-human studies and IND submissions
Represent CQP in a highly matrixed team setting to drive study execution and operational excellence toward product development goals
Lead the development of CQP related sections in regulatory documents (e.g., clinical protocols, INDs, regulatory meeting briefing books, summary documents for BLAs, responses to regulatory authorities) and represent clinical pharmacology in regulatory interactions
Lead/oversee the Clin Pharm data analysis, interpretation, and reporting to inform clinical implications and development decisions
Advocate and represent clinical pharmacology and MIDD strategies with internal and external stakeholders
Mentor junior team members to contribute to the development of a high-performing Clinical Pharmacology team
Leverage literature data and collaborate with external consultants, CRO partners and academic sites to problem solve and develop solutions to clinical pharmacology issues and grow organizational knowledge on mRNA platform

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
Annual discretionary bonus, other incentive compensation, or equity award

Fulltime

Director, Oncology Clinical Pharmacology Modeling and Simulation

At GSK, we have bold ambitions for patients, aiming to positively impact the hea...

Location

United States , Collegeville; Waltham; Durham

Salary:

188100.00 - 313500.00 USD / Year

GSK

Expiration Date

Until further notice

Requirements

PhD in Quantitative Clinical Pharmacology and Pharmacometrics disciplines (e.g., pharmacology, engineering or statistics) and experience in using modelling/simulation to solve practical problems in industry or academia. PharmD or Master's degree in the same disciplines with an additional 4 years of relevant experience may be considered
5+ years of utilizing skills in mechanistic PKPD and longitudinal disease modelling
and verifiable proficiency in pharmacometric tools NONMEM or R
3+ years of experience in planning, performing, and reporting model-based analysis of clinical data per industry and regulatory standards

Job Responsibility

Defining and executing model-based development strategies for oncology projects
Planning, conducting and reporting exposure-response analysis, simulation-based trial design and dose selection, and population PK modelling
Applying innovative methods such as drug-disease modeling, longitudinal exposure-response analysis, model-based meta-analysis, quantitative systems pharmacology and AI/ML informed analyses to enhance data use and trial efficiency
Presenting strategy and defending outcome of model-based approaches to internal governance boards and regulatory agencies
Contributing to clinical program design, trial protocols, analysis plans, study reports and regulatory submissions
Write or review clinical pharmacology components of regulatory documents and responses such that GSK products are rapidly and efficiently approved with optimum labelling (with regards to the clinical pharmacology, modelling and simulation contents)
Implement best practices, trends, lessons learned from internal and external sources to further clinical pharmacology modelling and simulation contributions to R&D pipeline
Ability to interact with line and middle management, staff and external contacts on a functional, strategic and tactical level
Promoting model-informed drug discovery and development through external collaboration, journal publication and conference presentation

What we offer

Competitive base salary
Annual bonus based on company performance
Flexible working options available for most roles
Learning and career development
Access to healthcare & wellbeing programmes
Employee recognition programmes
Health care and other insurance benefits (for employee and family)
Retirement benefits
Paid holidays
Vacation

Fulltime

Senior Director, Clinical Development, Oncology

Moderna is seeking an experienced oncology drug developer lead Clinical Developm...

Location

United States , Cambridge, Massachusetts; Princeton, New Jersey

Salary:

210900.00 - 379200.00 USD / Year

Moderna

Expiration Date

Until further notice

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

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

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

Clinical Development Director

ViiV Healthcare is a global specialty HIV company, the only one that is 100% foc...

Location

United States; United Kingdom , Durham; London

Salary:

Not provided

GSK

Expiration Date

Until further notice

Requirements

B.S. OR Masters OR Ph.D. OR Pharm.D., with 5 plus years of recent drug development experience in a pharmaceutical industry or CRO environment leading the scientific aspects of clinical program(s) and regulatory submission(s)
Prior drug development experience in HIV / infectious diseases
Experience in working with or writing study protocols, informed consent forms and clinical study reports
Experience with reviewing and interpreting clinical and scientific data
Experience in contributing to end-to-end clinical development strategy, including study design, data interpretation, risk assessment, and milestone planning
Experience translating complex study-level issues into broader program-level recommendations and decisions
5 plus years leading cross-functional teams, including internal and external partners (e.g. 3rd parties, academic partners, and subcontracted organizations)
Experience with managing multiple programs concurrently

Job Responsibility

Helps drive the strategy of ViiV Healthcare early- and/or late-stage development programs
Accountable for the development, finalization, and amendments of study protocols with appropriate internal/external stakeholder input while ensuring protocol fulfills strategic objective of clinical development/ integrated evidence plan
Liaises with Operations, Clinical Pharmacology, Medical, Regulatory and Commercial Leads to ensure study/program evaluates key aspects of the Asset Target Product Profile critical to product differentiation/reimbursement where possible
May co-lead Clinical Matrix Teams with the accountable physician
Provides scientific oversight of clinical studies, including assurance that data collection and study analysis plans are aligned with protocols, thereby allowing for intended scientific interpretation of study data and results
Partners with study team to ensure that all regulatory reporting requirements are met
Collaborates with physicians and other study team members and stakeholders to enable appropriate review of safety data
May assist or take leading role in identification of safety review committee members and preparation of interim safety review charter document
Works closely with study physician(s) to help monitor safety and benefit/risk for studies
Works with the study team to help to create evidence generation and scientific outputs including content of investigator meeting, clinical study report, preparation of study results for scientific meetings, congresses, and external journal publications, preparation regulatory documents, and other relevant study documents

What we offer

Competitive base salary
Annual bonus based on company performance
Flexible working options available for most roles
Learning and career development
Access to healthcare & wellbeing programmes
Employee recognition programmes

Fulltime

Director/Senior Director Of Clinical Research

Join Hemab, a clinical-stage biotech company, on an exciting journey to build th...

Location

Denmark , Copenhagen

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

Advanced degree (MD, PhD, PharmD) in life science or health science field
5+ years in clinical development within biotech/pharmaceutical industry or equivalent professional experience
Proven track record executing Phase I-III clinical trials
Strong understanding of regulatory environment and experience with regulatory interactions
Extensive knowledge of GCP, clinical trial methodology, clinical processes, and regulatory requirements
Experience in bleeding/thrombosis disorders, ultra-rare diseases, women with bleeding disorders
Experience working in translational research groups, working to interrogate new targets and to select drug candidates
Leadership of clinical strategy and content for regulatory submissions (BLA, MAA, IND, CTA)
Team leadership and vendor management experience
Pediatric clinical development experience

Job Responsibility

Develop clinical development strategies, study designs, and protocols that meet scientific and regulatory objectives
Oversee clinical trial documentation and study execution, including endpoint selection, medical monitoring, and clinical trial data review/interpretation
Monitor program progress and develop contingency plans as needed
In collaboration with Clinical Operations, responsible for oversight of study enrolment and timelines for key deliverables
Collaborate with Discovery teams to identify and interrogate new drug candidates
Support regulatory submissions and documentation
Ensure adherence to GCP, ICH guidelines, and company policies
Work closely with Clinical Operations, Clinical Science, Biostatistics, Regulatory Affairs, Medical Affairs, Quantitative Clinical Pharmacology and Safety/Pharmacovigilance teams to generate and deliver high-quality clinical data to support scientific and corporate objectives
Partner with key opinion leaders and subject matter experts to support study design and strategic elements of the CDP
Manage relationships with clinical study sites/investigators, CROs, vendors, and consultants

Fulltime

Director/Senior Director of Clinical Research

Join Hemab, a clinical-stage biotech company, on an exciting journey to build th...

Location

Denmark , København

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

Advanced degree (MD, PhD, PharmD) in life science or health science field
5+ years in clinical development within biotech/pharmaceutical industry or equivalent professional experience
Proven track record executing Phase I-III clinical trials
Strong understanding of regulatory environment and experience with regulatory interactions
Extensive knowledge of GCP, clinical trial methodology, clinical processes, and regulatory requirements
Demonstrated leadership with strong strategic and analytical thinking abilities
Excellent communication and presentation skills
Collaborative approach with ability to work across functions
Strong organizational skills and ability to manage multiple priorities
Comfortable in fast-paced biotech environment

Job Responsibility

Develop clinical development strategies, study designs, and protocols that meet scientific and regulatory objectives
Oversee clinical trial documentation and study execution, including endpoint selection, medical monitoring, and clinical trial data review/interpretation
Monitor program progress and develop contingency plans as needed
In collaboration with Clinical Operations, responsible for oversight of study enrolment and timelines for key deliverables
Collaborate with Discovery teams to identify and interrogate new drug candidates
Support regulatory submissions and documentation
Ensure adherence to GCP, ICH guidelines, and company policies
Work closely with Clinical Operations, Clinical Science, Biostatistics, Regulatory Affairs, Medical Affairs, Quantitative Clinical Pharmacology and Safety/Pharmacovigilance teams to generate and deliver high-quality clinical data to support scientific and corporate objectives
Partner with key opinion leaders and subject matter experts to support study design and strategic elements of the CDP
Manage relationships with clinical study sites/investigators, CROs, vendors, and consultants

Fulltime

Director of Discovery Pharmacology

As Director of Discovery Pharmacology, the main responsibility will be leading i...

Location

Sweden , Stockholm

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

PhD in pharmacology, biochemistry, cell biology or related discipline
Strong hands-on background (≥ 15 years) in a biotech or pharmaceutical setting
Experience in fibrotic disease biology with preference for background in the context of lung and/or kidney disease
Experience developing and interpreting cell-based and biochemical assays supporting small-molecule programs
Solid understanding of GPCR signalling, functional pharmacology and assay technologies
Experience working with CROs and managing outsourced biological work including in vivo study monitoring
Ability to translate complex biological data into clear project recommendations
Excellent written and verbal communication skills
Comfortable working in a small, agile, clinical-stage organization with a virtual R&D setting

Job Responsibility

Non-clinical team member for discovery-stage programs serving as biology and pharmacology expert in cross-functional discovery projects
Define biological hypotheses, assay cascades and decision criteria aligned with project goals and medicinal chemistry strategy
Design and implement robust in vitro and in vivo biological assays to assess disease-related mechanisms, ensuring scientific rigor and suitability for compound screening and characterization
Develop, validate, and optimize cell-based and biochemical GPCR assays (e.g. signalling, functional, pathway-specific readouts)
Oversee assay and study execution at CROs, including protocol development, troubleshooting, data quality review and timeline management
Support compound profiling, selectivity assessment, and mechanism-of-action studies, including pathway bias and functional pharmacology where relevant
Contribute to the development and execution of tissue-based disease models and in vivo disease models, working together with internal team members and external partners
Analyse and synthesize complex biological datasets to support compound prioritization and progression decisions
Contribute biological expertise to interactions with internal non-clinical, clinical, regulatory and IP functions as needed
Lead translational biomarker strategy and support identification, validation and implementation of pharmacodynamic and disease-relevant biomarkers to enable target engagement assessment and clinical translation

What we offer

Competitive compensation, benefits, and the opportunity to grow professionally in a collaborative environment where your expertise will be highly valued

Fulltime

Director, Provider Education & Risk Adjustment

The Physician Educator serves as a liaison between the Health Plan and the parti...

Location

United States , New York

Salary:

175000.00 - 200000.00 USD / Year

MJHS

Expiration Date

Until further notice

Requirements

Bachelor's Degree required or comparable work experience will be considered
Minimum 5 years of experience in professional services, including practice management, nursing, clinical documentation improvement or quality audit
2-3 years of teaching experience in a clinical setting preferred
2-3 years of progressive leadership experience preferred
Extensive knowledge of coding and documentation requirements including ICD-10-CM, CPT-4, and HCPCS
In-depth knowledge of medical terminology, anatomy and physiology, pharmacology, and pathology required
A general understanding of Health care insurance and Medicare managed care is highly preferred for this position
Excellent verbal and written communication skills, analytical skills, and organization skills required
Extensive problem-solving experience is required
Experience working with physicians and physician practices

Job Responsibility

Develop and maintain collaborative relationships with assigned providers/practices within Elderplan Network
Coordinate and present education of providers/practices related to risk adjustment, coding, and clinical documentation improvement
Assess workflow processes in physician practices that impact the ability to maximize Health Plan revenue achieved through the various risk adjustment payment models
Identify trends and barriers that interfere with correct coding and documentation practices in the physician practice sites, including but not limited to workflow, electronic health records, and clearinghouses
Adhere to CMS coding and documentation guidelines
Analyze medical record documentation and coding through a chart review process that identifies incorrect coding, coding lacking supporting documentation, and missed opportunities to capture risk adjustment diagnoses and associated revenue
Analyze and distribute reports to providers that summarize their performance related to coding and documentation and risk adjustment
Develop and implement strategic action plans based on findings of assessment of physician practice workflows and medical record documentation reviews
Maintain confidentiality of chart review results and member information
Maintain a current and in-depth knowledge of CMS guidelines related to risk adjustment, coding, documentation, as well as knowledge of new models of risk adjustment that impact Health Plan revenue

What we offer

Tuition Reimbursement for all full and part-time staff
Generous paid time off, including your birthday
Affordable and comprehensive medical, dental and vision coverage for employee and family members
Two retirement plans! 403(b) AND Employer Paid Pension
Flexible spending
Paid Student Loan Forgiveness Program (PSLF)

Fulltime

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Director, Clinical Pharmacology

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