Senior Director, Clinical Pharmacology Job at Kailera Therapeutics (Waltham)

Director, Clinical Pharmacology

We are seeking a motivated Director, Clinical Pharmacology, to join our growing ...

Location

United States

Salary:

230000.00 - 260000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

PhD or PharmD with relevant expertise in clinical pharmacology or pharmaceutical science
5+ years of direct industry experience in conducting clinical stage drug development
Experienced in developing clinical pharmacology plans and authoring relevant sections of clinical and regulatory documents
Knowledge and experience in the application of current practices in the areas of clinical pharmacology, pharmacokinetic and pharmacodynamic principles, drug metabolism, bioanalysis, biopharmaceutics
Fluency in model-informed drug development
Experience working with external CROs
Proficient in using common PK/PD modeling software (such as Phoenix WinNonlin, Prism, and other similar tools)
Ability to work proactively and effectively, with exceptional creative problem-solving skills and self-motivation
Ability to work in cross-functional teams within a highly dynamic environment
Strong project management skills with a high sense of urgency, ability to collaborate and influence effectively cross-functionally

Job Responsibility

Lead clinical pharmacology programs in immunology & inflammation, providing strategic planning for drug development activities
Influence, decide, and recommend key clinical pharmacology strategies across the drug development spectrum
Develop and help implement quantitative approaches to drug development programs
Work in close collaboration with different functions
Lead and present key Clinical Pharmacology information to teams, senior leaders, regulatory agencies, and external partners
Independently lead Clinical Pharmacology/PK/PD activities and provide scientific and strategic expertise
Support pediatric development, including protocol development and dose selection
Develop and oversee implementation of clinical pharmacology studies from protocol development to final study reporting
Lead the analysis, interpretation, and reporting of clinical PK/PD data, author clinical study reports
Develop and execute and/or oversee PK/PD modeling strategies to describe the relationship between drug exposure and response

What we offer

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
Three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

Fulltime

Senior Director, Clinical and Regulatory Writing

The Senior Director, Clinical and Regulatory Writing will serve as a strategic l...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Advanced degree in life sciences (M.D., or PharmD preferred)
MS, PhD with significant clinical pharmacology writing experience will be considered
12+ years of progressive experience in regulatory or scientific/medical writing in the biopharmaceutical industry, including 5+ years in a leadership role
Demonstrated experience developing content for major global regulatory submissions (e.g., IND, BLA, MAA), preferably in cell or gene therapy
Strong understanding of drug development processes, regulatory frameworks (FDA, EMA, ICH), and clinical trial documentation requirements
Exceptional writing, editing, and analytical skills with the ability to convey complex scientific data clearly and persuasively
Proven leadership capabilities, including team development, cross-functional collaboration, and vendor management
Proficiency in Microsoft Office Suite, document management systems (e.g., Veeva Vault), and electronic publishing tools
Strong project management skills with the ability to prioritize competing demands in a fast-paced, deadline-driven environment
Collaborative mindset with the ability to influence and guide stakeholders across disciplines and levels of seniority

Job Responsibility

Lead the clinical writing function in the development, review, and approval of regulatory documents to support global submissions (e.g., INDs, IMPDs, BLAs, MAAs, Orphan Drug Applications, Investigator Brochures, protocols, clinical study documents, PSPS/POIPs, Prime, RMAT)
Lead cross-functional content planning of regulatory submission modules, including data integration and interpretation, and ensuring consistency in strategic messaging for dossiers, meeting packages and responses to health authorities
Translate complex technical data from clinical and biostatistics teams into scientifically accurate, submission-ready documentation
Manage external consultants and contractors as needed to support Cabaletta submissions reviews, authoring, if needed, and gap analyses
Mentor, train, and manage a team of medical/regulatory/technical writers or cross-functional contributors in document development
Develop and implement strategic plans for medical writing activities, aligning them with clinical development, regulatory affairs, and overall business goals
Drive process improvements and develop standard practices for efficient, compliant and high-quality document delivery
Collaborate with Clinical Operations and external CROs to ensure inspection readiness of clinical trial documentation, including informed consents, study manuals, and IRB/IBC responses

What we offer

health and retirement, PTO, and stock option plans

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

Director DMPK

Are you ready to make a groundbreaking impact in the world of biotechnology? Joi...

Location

United States , Palo Alto

Salary:

190000.00 - 240000.00 USD / Year

Proclinical

Expiration Date

Until further notice

Requirements

Advanced degree (PhD) in pharmacokinetics, drug metabolism, or a related field
Expertise in small-molecule DMPK with experience spanning discovery and development
Proficiency in analyzing PK and PK-PD data using relevant software tools
Strong understanding of regulatory guidelines for small-molecule drug development
Experience preparing regulatory submissions and interacting with regulatory agencies
Ability to oversee bioanalytical method development and validation
Excellent communication, analytical, and problem-solving skills
Leadership capabilities with a detail-oriented and adaptable approach in a fast-paced environment

Job Responsibility

Develop and implement DMPK and PK-PD strategies aligned with discovery and development goals
Serve as the DMPK program lead, overseeing study design, execution, data analysis, interpretation, and reporting
Provide expert insights on DMPK data and present findings to project teams, senior leadership, and external stakeholders
Collaborate with cross-functional teams, including medicinal chemistry, toxicology, pharmacology, CMC, and clinical groups, to support data-driven decision-making
Manage bioanalytical and DMPK studies conducted internally and through external partners (CROs)
Author and review DMPK-related sections of regulatory documents such as IND, IB, CTA, NDA, and BLA, and address regulatory inquiries
Support clinical pharmacology activities, including first-in-human dose projections
Ensure high standards of scientific rigor, quality, and documentation throughout all processes

Fulltime

Senior Director - Head of DMPK/ADME

Zealand Pharma is expanding its Drug Metabolism and Pharmacokinetics (DMPK) capa...

Location

Denmark , Søborg

Salary:

Not provided

Life Science Talent

Expiration Date

May 24, 2026

Requirements

PhD in pharmaceutical sciences or similar with extensive relevant industry experience.
Extensive experience addressing DMPK challenges for multiple modalities
Proven people-leadership experience, including building, mentoring and developing high-performing scientific teams across sites and/or in matrix environments
Experience contributing to regulatory-facing DMPK content (e.g., IND/CTA support, responses to agency questions)
Demonstrated ability to set DMPK strategy aligned with project and portfolio priorities, balancing scientific rigor with speed and resource constraints
Experience ensuring quality, compliance and scientific rigor in nonclinical assay validation oversight, sample analysis oversight, and vendor/CRO interactions

Job Responsibility

Provide strategic leadership and oversight for DMPK / ADME strategy and execution across the portfolio
Build, mentor, and scale DMPK capabilities, talent, and ways of working at the Boston site, ensuring strong alignment and integration with Copenhagen standards and interfaces
Oversee bioanalytical method development, including robust nonclinical assay validation and oversight of sample analysis (internal and external)
Lead in vitro ADME activities, including stability and drug–drug interaction (DDI) assessments, ensuring fit‑for‑purpose study design, interpretation, and documentation
Oversee in vivo pharmacokinetics and metabolite identification, integrating findings into a coherent ADME understanding and risk‑based decision framework
Deliver high‑quality nonclinical PK summaries and integrated DMPK data packages to support project decision‑making, governance processes, and external‑facing documentation as required
Drive continuous improvement through the implementation of automation, digital, and AI enabled approaches within DMPK workflows
Provide scientific leadership in cross functional project teams, partnering closely with Discovery, Translational, Clinical Pharmacology, Toxicology, and Regulatory colleagues
Ensure effective oversight of external partners and CROs, including scientific quality, timelines, and budget accountability
Contribute to regulatory strategy and interactions by ensuring DMPK content is scientifically sound and inspection ready

Fulltime

Director, Medicinal Chemistry

Enveda is looking for a Director, Medicinal Chemistry to join our team in Hydera...

Location

India , Hyderabad

Salary:

Not provided

Enveda

Expiration Date

Until further notice

Requirements

Doctor of Philosophy in Synthetic Organic Chemistry
15-20 years of post-PhD experience in Medicinal Chemistry
Proven track record of delivery of leads and clinical candidates to the pharmaceutical industry
Management and mentoring of synthetic chemists
Good understanding of intellectual property of medicinally valuable compounds with respect to composition of matter, method of use and chemical processes
Strong understanding of safety practices in organic synthesis laboratories

Job Responsibility

Lead medicinal chemistry activities for two or more projects in parallel
Involved in identifying pre-leads, design and optimization of leads for potency, selectivity and druggability and also strong IP generation
Recruit PhD and M. Sc. synthetic chemists and mentor them as medicinal chemists and manage their performance and improve their productivity
Collaborate with peers in Medicinal Chemistry and work as a team to increase delivery of compounds to the Clinical Pipeline
Collaborate with Senior Leaders in other functional departments such as ADME, Analytical Sciences and Pharmacology and deliver high value molecules
Report to the VP, Discovery Chemistry
Collaborate on Medicinal Chemistry of Lead Generation and Lead Optimization of Pipeline Projects
Understand Structure Activity Relationships and Structure Property Relationships of various projects
Collaborate with Medicinal Chemistry, Pharmacology, Analytical, ADME, Tox, IP, Site and Global Leadership
Develop appropriate flow schemes with relevant in vitro, in vivo, ADME/PK and tox studies

What we offer

Culture
Medical
Block Leaves
Work-Life Harmony

Fulltime

Associate Director Medical Writer

The Associate Director Medical Writer is an individual expert who can manage and...

Location

Canada , Mississauga

Salary:

Not provided

GSK

Expiration Date

Until further notice

Requirements

PhD or relevant working experience within the life sciences space
Proven track record in writing clinical/regulatory documents including, but not limited to: protocols, clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions
Work in a matrix team to ensure delivery of high quality, fit-for-purpose clinical documents that accurately reflect associated data, and are in line with GSK standards and global, regional and/or local regulatory requirements
Experienced as a significant contributor in planning and production of clinical dossier documents for regulatory submissions worldwide
Demonstrated effectiveness in management of projects of increasing scope and complexity
Understanding of the interdependencies of various contributing functions (e.g., clinical pharmacology, biomarkers, health outcome)
Ability to quickly assess complex situations, apply scientific, operational, and submission development knowledge and implement effective plans for solutions
High-level computer skills and general computer literacy
Demonstrated knowledge of scientific methodology and statistical principles in the design, conduct and description of clinical research
Ability to interpret clinical data, assess trends and patterns in text and statistical data, and effectively organize content and messages in clinical reports and summary documents

Job Responsibility

Contribute to the planning, authoring, review, and approval of clinical/regulatory documents for medical writing project to achieve a successful outcome within the required timelines
Possess highly effective communication skills and is capable of presenting ideas and data clearly to a group, including key stakeholders at a senior level
Provide major input to submission teams in development of submission plans, timelines, document content and dependencies
Advises on or recommends methods for achieving accelerated timelines, including review tools and automation
Actively contribute to development of training materials for clinical document preparation
provides mentoring and/or training on clinical documentation and submission planning to individuals or teams
Champion change and contributes to departmental or cross-functional process improvement initiatives and develops/revises standards for GSK submission documents
Effectively contribute to process improvement activities

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

Nurse Practitioner

The Nursing department has an opening for a Full-Time Nurse Practitioner. The su...

Location

Canada

Salary:

52.72 - 62.05 CAD / Hour

Riverside Health Care

Expiration Date

Until further notice

Requirements

Current registration with the College of Nurses of Ontario as a Registered Nurse in the Extended Class (Primary Health Care or Adult) and entitled to practice
Post-graduate education and experience in gerontology
Specialty certification in gerontological nursing
Post-graduate certificate and experience in palliative care
Maintains confidentiality and acts in an ethical manner
Is a member of the primary care team and seeks appropriate consultation as required
Engages in ongoing professional development
Develops in-depth expertise in care of older persons
Develops in-depth expertise in leadership
Holds professional liability protection

Job Responsibility

Reports directly to the Director of Nursing or Administrator and is also accountable to the Medical Director
Is a primary care provider to residents and works within her/his legislative scope of practice
Collaborates with the resident and family/care giver, and the health care team in the development, implementation and evaluation of the residents plan of care
Provides leadership and mentorship to LTCH staff
Leads and collaborates in research, education, and evidence-based practice initiatives
70% of time must be while engaged in Direct Care to Residents
Provides comprehensive primary care to residents as part of the interdisciplinary health care team
Performs a person-centered health assessment of residents on admission, annually and as needed
Conducts person-centered comprehensive health histories
Collaborates with the resident to develop a person-centered plan of care

Fulltime

Senior Director, Clinical Pharmacology

Kailera Therapeutics

Location:
United States , Waltham

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
January 03, 2026

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

Similar Jobs for Senior Director, Clinical Pharmacology

Director, Clinical Pharmacology

Senior Director, Clinical and Regulatory Writing

Senior Director, Clinical Development, Oncology

Director DMPK

Senior Director - Head of DMPK/ADME

Director, Medicinal Chemistry

Associate Director Medical Writer

Nurse Practitioner

Senior Director, Clinical Pharmacology

Kailera Therapeutics

Location:United States , Waltham

Category:Research and Development

Contract Type:Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:January 03, 2026

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

Similar Jobs for Senior Director, Clinical Pharmacology

Director, Clinical Pharmacology

Senior Director, Clinical and Regulatory Writing

Senior Director, Clinical Development, Oncology

Director DMPK

Senior Director - Head of DMPK/ADME

Director, Medicinal Chemistry

Associate Director Medical Writer

Nurse Practitioner

Location:
United States , Waltham

Category:
Research and Development

Contract Type:
Not provided

Job Posted:
January 03, 2026