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Senior Director of Translational Medicine and Clinical Pharmacology

3 months ago


Princeton New Jersey, Mercer County, NJ, United States Sun Pharma Full time

Senior Director of Translational Medicine and Clinical Pharmacology

Sun Pharma is the world’s fourth largest specialty generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe. Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S., and we are rapidly ramping up our presence in the specialty branded market with a focus on dermatology, ophthalmology and onco-dermatology.

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 in 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 functional 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 a 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:

  • 3-5+ years of biotech and/or pharmaceutical drug experience
  • 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

Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.

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.