Senior Director, Translational Medicine and Clinical Pharmacology - Princeton, United States - SUN PHARMA
Description
Sun is seeking a Director/Senior director within its Translational Medicine and Clinical Pharmacology group in Princeton, NJ. The director will report into Vice President of Translational Medicine and Clinical Pharmacology. Translational Medicine in the Development group is responsible for early clinical development of novel therapeutics, working in close collaboration with nonclinical and clinical functional areas. We work with all therapeutic areas within our Development Division. We are seeking a highly qualified individual for a position in our group. Candidates must have a strong background in basic and/or clinical translational research and a desire to work collaboratively across different therapeutic areas.
Translational Medicine is specifically responsible for:
Contributing to the identification of novel targets by partnering with research teams to bring a clinical perspective into target identification and validation, and executing clinical studies to evaluate the relevance of potential targets to human disease to support investment in full development
Development of biomarker strategies through cross-functional teams that provide line-of-sight from First-in-Human studies through clinical Proof-of-Concept.
Leadership of the early clinical development strategy for novel therapy programs from preclinical candidates through initial clinical testing (Phase 1) and clinical Proof-of-Concept (Phase 2)
Development and execution of clinical pharmacology strategies to support later stages of development from Proof-of-Concept (Phase 2) through worldwide marketing application
Success depends on the integrity, knowledge, imagination, creativity, skill, diversity and teamwork of the people in the group. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of the global team, you will collaborate with talented and dedicated colleagues across the Development Division while developing and expanding your career.
Primary Responsibilities:
Key member of an product development team, providing leadership in designing and executing early clinical development strategy
Development and execution of early clinical strategy for novel therapeutics including authoring initial clinical biomarker plans, early clinical development plans, and clinical pharmacology studies for programs in Phases I through IV of development
Safe and timely execution of Phase I studies; close collaboration with internal and external clinical study support staff and scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations)
Provide clinical pharmacology support for programs through the worldwide marketing application filing including supportive registration documents and presentations
Provide clear, timely communication and interpretation of study results to functional area experts and governance/senior management
Contribute to assessment of internal and external opportunities
Interface broadly with key functions including discovery sciences, preclinical development groups, toxicology, clinical operations, drug metabolism, regulatory affairs, and late-stage clinical research
Qualifications:
Proven track record in clinical medicine or clinical research, and background in biomedical research
Demonstrated record of scientific scholarship and achievement, willingness to work collaboratively across different therapeutic areas.
Strong interpersonal, writing and presentation skills, as well as the ability to function in a team environment are essential
Prior specific experience in clinical research and prior publication preferably with experience in the area of basic or translational research and experience with early clinical development and patient care
Clinical Board Certification preferred
Education:
MD/PhD or MD
Biotech and/or pharmaceutical drug experience preferred
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.