Director, Clinical Pharmacology

Ideal School of Allied Health Care Inc; Cambridge (MA); On-site; USD 150,000 - 220,000; Full time

Job summary

A leading Biotechnology firm seeks a Director of Clinical Pharmacology to support clinical activities for multiple assets. This role emphasizes strategy development, regulatory documentation, and managing external partnerships to ensure successful clinical trials. Candidates should have advanced degrees and extensive experience in drug development.

Qualifications

• Advanced degree in clinical pharmacology, pharmaceutical sciences, or related areas.
• 7+ years of relevant experience in clinical drug development.
• Experience with clinical pharmacology strategies and regulatory submissions.

Responsibilities

• Develop and implement the clinical pharmacology strategy for clinical stage assets.
• Co-author regulatory documents for submission to global health authorities.
• Independently represent Clinical Pharmacology in clinical trial working teams.

Skills

Clinical Development

Regulatory Interaction

Pharmacokinetics

Pharmacodynamics

Communication Skills

Education

PhD or PharmD in Clinical Pharmacology or related areas

Tools

NONMEM

R

WinNonlin

Monolix

Job description

Cullinan Therapeutics, Inc.(Nasdaq: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients.

We have strategically built a diversified portfolio of clinical-stage assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in both oncology and autoimmune disease. Our portfolio encompasses a wide range of modalities, each with the potential to be best and/or first in class.

Anchored in a deep understanding of oncology, immunology, and translational medicine, we create differentiated ideas, identify the most appropriate targets, and select the optimal modality to develop transformative therapeutics across a wide variety of cancer and autoimmune indications.

We push conventional boundaries from candidate selection to differentiated therapeutic, applying rigorous go/no go criteria at each stage of development to fast-track only the most promising molecules to the clinic and, ultimately, commercialization.

With deep scientific expertise, our teams exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients.

Summary:
The Director of Clinical Pharmacology will be responsible for supporting both clinical pharmacology activities for multiple clinical stage assets at Cullinan Therapeutics. This role includes working on clinical development teams to develop and implement the clinical pharmacology strategy, design, develop study protocols, and study reports. This role will also involve working closely with internal clinical development teams, CROs, and study collaborators to file regulatory documents and execute clinical development plans.

Position Responsibilities:
-Independently represent Clinical Pharmacology as a member of program, clinical sub-team, clinical trial working teams by contributing to clinical development strategy, clinical trial design, clinical study protocols, executing and coordinating clinical trial conduct and finalizing clinical study reports.
-Develop and execute program specific Clinical Pharmacology strategy and plan. Align plans with cross functional study and program teams.
-Design, conduct, and scientific interpretation of Clinical Pharmacology studies and provide effective Clinical Pharmacology support to patient trials.
-Actively participate in cross-departmental teams, company-wide initiatives and work streams.
-Manage CROs for Clinical Pharmacology related studies and activities inclusive of developing study timelines, objectives and budgets; ensuring accuracy of project delivery and pro-actively identifying hurdles and providing solutions.
-Co-author regulatory documents for submission to global health authorities, including eCTD sections for IND and NDA, Investigators Brochure (IB), and Briefing Documents.

Candidate Requirements:
-Advanced Degree in clinical pharmacology, pharmaceutical sciences, or related areas (e.g.: pharmacokinetics, pharmacology, drug metabolism or etc.). (PhD or PharmD preferred)
-7+ years of relevant experience in clinical drug development in industry or academic/research
-Experience formulating and executing Clinical Pharmacology strategies including design, interpretation and reporting of clinical pharmacology studies is required
-Direct interaction with the FDA and international regulatory authorities preferred
-A working knowledge or previous experience with pharmacokinetic/pharmacodynamics, drug-drug interactions, PK/PD data management/analysis, and clinical development is a plus.
-Knowledge of ICH guidelines in the design, analysis, and interpretation of clinical pharmacology studies.
-Familiarity with related disciplines (e.g., bioanalysis, biostatistics, toxicology, regulatory affairs, clinical operations) in the drug development process.
-Broad familiarity with the drug development process and Model Informed Drug Development, particularly for oncology is highly desirable as is prior experience working with CROs.
-Working knowledge of common tools for quantitative clinical pharmacology such as NONMEM, R, WinNonlin, and/or Monolix. Ability to perform non-compartmental pharmacokinetic analysis (NCA). Expertise in PK/PD modeling is a plus but is not required.
-Knowledge or experience with developing immune-based therapies (mAbs, TCEs, etc) including development of immune-oncology and/or autoimmune therapies is also a plus.
-Demonstrated ability to contribute successfully in a multi-disciplinary team environment
-Ability to make sound judgement in complex situations and adapt to changing business needs by prioritizing multiple tasks.
-Ability to influence key stakeholders and drive decisions both internally and externally
-Excellent interpersonal and communication skills both written and oral
-Personal accountability for timely delivery of results