Celgene

Associate Director Clinical Pharmacology and Pharmacometrics

Posted on: 11 Apr 2021

Princeton, NJ

Job Description

At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through science. In oncology, hematology, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Position Summary

* Drives the implementation, planning, and execution of clinical pharmacology activities and works with some supervision on assigned projects.

* Leads, plans, and executes trial level activities and development of compounds across relevant therapeutic areas.

* Leads Pharmacokinetics/Pharmacodynamics principles and model-based analyses to support drug development.

* Collaborates within Clinical Pharmacology and cross-functionally to assist with functional development strategies.

* Provides mentorship within the Clinical Pharmacology and Pharmacometrics function

Position Responsibilities

* Accountable for Clinical Pharmacology and Pharmacometrics Plan

* Lead design of Clinical Pharmacology Studies and manages data analysis, interpretation, and reporting

* High proficiency in PK, PK/PD, and model informed drug development (MIDD) principles and analyses

* Collaborate on cross-functional drug development teams, regulatory submissions, and departmental initiatives; serves as Clinical Pharmacology subject matter expert

* Participate in interactions with health authorities; serves as Clinical Pharmacology subject matter expert

* Lead or participate in departmental initiatives; may be involved in external initiatives based on proficiency

* Provide expertise based on proficiency to Business Development teams

Degree Requirements

MS, PhD or PharmD in relevant field

Approximately 5+ years experience with demonstrated progression in Clinical Pharmacology and Pharmacometrics knowledge, including experience with general drug development process and small molecule and/or biologic drug property characterization

Key Competency Requirements

* In-depth knowledge of current practices and issues in Clinical Pharmacology and Pharmacometrics

* Strong written and oral communication skills necessary to report on and deliver scientific presentations

* Demonstrated ability to work in a dynamic team-oriented environment

* Provide mentorship and guidance to staff and the CP&P function

* Supervise a colleague in CP&P, as needed

* Independently serve as the CP&P lead for one or more assets in the BMS drug development program

* Programming experience is highly desired (e.g., NONMEM, R, and WinNonlin. SAS, Splus, etc.)

* Quantitative data analysis, POP PK/PD, and data visualization skills are highly desired

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Celgene

Summit, NJ

Celgene Corporation, a biopharmaceutical company, discovers, develops, and commercializes therapies for the treatment of cancer and inflammatory diseases worldwide. It offers REVLIMID, an oral immunomodulatory drug for multiple myeloma (MM), myelodysplastic syndromes (MDS), and mantle cell lymphoma; POMALYST/IMNOVID to treat multiple myeloma; OTEZLA, a small-molecule inhibitor of phosphodiesterase 4 for psoriatic arthritis and psoriasis; and ABRAXANE to treat breast, non-small cell lung, pancreatic, and gastric cancers.

The company’s products also include IDHIFA for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (rrAML) with an isocitrate dehydrogenase-2 mutation; VIDAZA, a pyrimidine nucleoside analog for intermediate-2 and high-risk MDS, chronic myelomonocytic leukemia, and AML; THALOMID to treat patients with MM; and ISTODAX, an epigenetic modifier. Its preclinical and clinical-stage product candidates include small molecules, biologics, and cell therapies for immune-inflammatory diseases, myeloid diseases, epigenetics, protein homeostasis, and immuno-oncology.

The company has agreements with BeiGene, Ltd; Acceleron Pharma, Inc.; Agios Pharmaceuticals, Inc.; bluebird bio, Inc.; Lycera Corp.; Juno Therapeutics, Inc.; EXSCIENTIA LTD.; and IMIDomics SL, as well as immuno-oncology collaboration with Sutro Biopharma. Celgene Corporation was founded in 1980 and is headquartered in Summit, New Jersey.

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