Director, Clinical Pharmacology
Constellation Pharmaceuticals is a pioneering epigenetics company, focused on the development of novel molecules targeting chromatin regulatory proteins for therapeutic applications in oncology. We have small molecule therapeutics in various stages of clinical and preclinical development, including our lead product candidate, BET-inhibitor pelabresib for myelofibrosis, and we are building an integrated clinical pharmacology team that will serve as a strategic partner in developing this and other pipeline assets. We are looking for passionate clinical pharmacology professionals to be part of the future of epigenetics and gene control therapy! We believe that each team member can impact and improve the lives of patients and that we are #BrighterTogether!
We are looking for an experienced clinical pharmacologist with expertise in oncology drug development to lead clinical pharmacology strategy and execution in our EZH2 program. The Director of Clinical Pharmacology plays a key role as a member of the program core team providing Clinical Pharmacology perspectives and delivering modeling and analyses necessary to evaluate clinical options, enable plans, and optimize development programs. This includes gap analysis, study design, PKPD analysis and modeling, program assessment, and internal collaborations to help execute programs. The Director of Clinical Pharmacology is responsible for developing strategy and executing all aspects of clinical pharmacology-related support for drug products, including design and execution of clinical pharmacology studies; design of clinical pharmacology portion of other clinical studies; analysis, interpretation, and reporting of data; and communication of data in regulatory documents and meetings. In this newly formed and growing function, the Director may also have the opportunity to hire, manage, and develop more junior scientists.
This position reports directly to the Vice President of Clinical Pharmacology within the Clinical Development organization.
In this role you will:
- Design, implement, drive, and monitor clinical pharmacology strategy on program teams to which you are assigned
- Contribute to program strategy, protocol preparation, study execution, data review/analysis, study reports, and regulatory document preparation; write and review clinical pharmacology summary documents
- Work with internal teams and external partners to execute program team objectives
- Oversee clinical pharmacology and bioanalytical vendors and consultants as appropriate
- Develop and execute modeling and simulation plans; use model-based approaches to improve the efficiency of drug development and support dose selection and optimization
- Ensure/perform appropriate PKPD analysis including population PK, PKPD modeling and simulation, meta-analysis, and disease modeling as required by the program to aid in dose selection, trial design, and/or program decision-making
- Lead clinical pharmacology contributions to all regulatory documents including Investigator Brochures
- Lead the resolution of clinical pharmacology queries from drug regulatory agencies, taking a lead role in writing and reviewing responses to clinical pharmacology regulatory queries
- Accountable and responsible for analysis of clinical PK data
- Apply innovative analysis methods to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states to optimize doses, dosage regimens and study designs throughout clinical drug development in collaboration with Translational Science and Statistics (as relevant).
We are looking for people who:
- PhD in Pharmacokinetics, Pharmaceutical Sciences, Engineering or related field required
- A minimum of 10 years’ experience in the biopharma industry in a Clinical Pharmacology role with at least 3 years in Oncology and proven ability to represent Clinical Pharmacology on project teams and with external partners
- Experience with NDA or BLA Oncology submissions and regulatory interactions
- Experience partnering with DMPK and Translational Science colleagues to ensure relevant clinical pharmacology strategy is developed
- Experience working cross-functionally and working with external partners
- Strong knowledge of the role of clinical pharmacology in drug development, including experience in the application of translational pharmacology and model-informed drug development
- Ability to perform in fast-paced, dynamic, constantly evolving environment
- Excellent communication and organizational skills and attention to detail
- Strong time management skills; ability to prioritize multiple tasks efficiently
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Constellation Pharmaceuticals recognizes the value of diversity in our workforce. We are committed to equal opportunity. We consider all qualified employment applicants without regard to race, religion, color, gender, age, national origin, sexual orientation, gender identity, gender expression, partnership status, status as a protected veteran, status as an individual with a disability, or any other status protected by federal, state, or local law. Individuals who hold legal work authorization applicable to employment at Constellation Pharmaceuticals in the United States will be considered without regard to citizenship/alienage. Constellation Pharmaceuticals is a participant in E-Verify.
We are not accepting unsolicited resumes from employment agencies for any employment opportunities at this time.