Director Clinical Pharmacology

Cullinan Oncology is dedicated to creating new standards of care for patients with cancer.

We innovate without borders to find the most promising clinic-ready cancer therapies, whether from our own discovery efforts or through exceptional engagement with our academic and industry partners.

Anchored in a deep understanding of immuno-oncology and translational cancer medicine, we leverage our scientific excellence in small molecules and biologics to create differentiated ideas, identify unique targets, and select the optimal modality to develop transformative therapeutics across cancer indications.

Powered by our novel research model, we push conventional boundaries from candidate selection to cancer therapeutic, applying rigorous early experimentation to fast-track only the most promising assets to the clinic and ultimately commercialization.

As a result, our diversified pipeline is strategically built with assets that activate the immune system or inhibit key oncogenic drivers across a wide range of modalities, each with the potential to be the best or first in their class.

Our people possess deep scientific expertise, seek innovation openly, and exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients with cancer.

Summary:

The Director of Clinical Pharmacology Director will be responsible for supporting both clinical pharmacology activities for multiple clinical stage assets at Cullinan Oncology. 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.

• 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. 

• 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.  
• orking 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 including development of immune-oncology 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 

Cullinan Oncology is proud to be an Equal Opportunity Employer. We are committed to creating an inclusive and diverse environment for all employees and applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.

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