Director, Clinical Pharmacology Job at Apogee Therapeutics

Medical Director/Senior Medical Director, Clinical Development, Genetic Diseases

The Medical Director in Clinical Development will serve as the Medical Lead for ...

Location

United States , Cambridge

Salary:

210000.00 - 375000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

MD, DO or equivalent ex-US medical degree with 15+ years experience
Minimum of 4 years of Pharmaceutical/Biotech industry experience in clinical development and medical monitoring
Board certification/eligibility in endocrinology or metabolic disorders, or another relevant specialty highly desired
Strong oral and written communication skills to influence others
Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate
Clinical development and/or clinical experience in rare disease, cell & gene therapy is a plus
Ability to work independently to resolve challenges

Job Responsibility

Serves as the Clinical Development lead on the cross-functional Program Team and co-lead the Clinical Development Sub-team for assigned programs
Support development of Target Product Profile (TPP) and Clinical Development Plan (CDP)
Serves as the medical monitor for assigned studies including design, execution and interpretation study data
Provides scientific and clinical input to study-related documents and analysis plans including Informed consent forms (ICF), clinical research forms (CRF), statistical analysis plans (SAP), clinical pharmacology and biomarker analysis plans
Ensure patient safety on clinical trials and adherence to Good Clinical Practices (GCP)
Contribute to the development of regulatory documents in support of regulatory submissions, including clinical section of IND's and CTA's, safety reports, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate
Acts as liaison between Clinical Development and other internal groups at BEAM for assigned studies
Establishes strong collaborations with study investigators, outside medical experts and represents BEAM during investigator meetings and advisory boards
Contribute to the development and planning of Advisory Board meetings in the relevant therapeutic areas

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 Pharmacology

The Senior Director, Clinical Pharmacology will report to the Vice President, Tr...

Location

United States , Waltham

Salary:

210000.00 - 270000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

10+ years of experience in clinical pharmacology in the biotech or pharmaceutical industry
Proven track record of supporting drug candidates at various stages of development within the clinical pharmacology function
Strong expertise in pharmacokinetics, pharmacodynamics, and model-informed drug development strategies
Comprehensive knowledge of global regulatory requirements for clinical pharmacology and experience contributing to regulatory submissions (IND, NDA, BLA)
Excellent leadership and cross-functional collaboration skills, with the ability to influence and drive strategy across teams
Exceptional written and verbal communication skills, including the ability to convey complex scientific concepts to diverse stakeholders
PhD or PharmD in a relevant scientific discipline (e.g. clinical pharmacology)

Job Responsibility

Develop, implement, and/or supervise clinical pharmacology strategies to drive Kailera’s programs through all the stages, from research to Phase 3
Serve as the clinical pharmacology lead on project teams, providing subject matter expertise
Work collaboratively with functional partners, including clinical development, biostatistics, translational medicine, CMC, toxicology, clinical operations, and regulatory to deliver project and corporate objectives
Ensure robust development and alignment of clinical pharmacology strategies with the therapeutic indication, patient population, and development phase
Advocate and represent clinical pharmacology, PK/PD, and model-informed drug development
Develop the clinical pharmacology package, including dose selection and optimization
Contribute to the development of regulatory documents (e.g. clinical protocols, INDs, NDAs, responses to regulatory authorities) and represent clinical pharmacology in regulatory interactions
Build a culture of collaboration, innovation, and accountability within the team
Partner with translational medicine colleagues to integrate clinical pharmacology strategy into broader translational, platform, and clinical development strategies

What we offer

Comprehensive health coverage
Flexible time off
Paid holidays
Year-end shutdown
Monthly wellness stipend
Generous 401(k) match
Tuition reimbursement
Commuter benefits
Disability and life insurance
Annual bonus opportunities

Fulltime