Title:  Sr. Manager, Pharmacokinetics (PK) Modeler

Sun Pharma is the world’s fourth largest 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. 

Summary:

Sun is seeking a Senior Manager in the Quantitative Pharmacology group within its Translational Medicine and Clinical Pharmacology function in Princeton, NJ.  The Quantitative Pharmacology group is responsible for the oversight over drug development aspects related to clinical pharmacology and pharmacometrics of clinical development candidates, 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 to join the group. Candidates must have a strong background in quantitative drug development and a desire to work collaboratively across different functional areas, as well as with external vendors and partners.

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. This position is located in Princeton, New Jersey and employs a HYBRID work schedule: 3 days in office; 2 days remote.

Primary Responsibilities:

• Key member of a product development team, contributing to the advancement of novel chemical entities bringing a quantitative perspective into strategic development to support continued investment
• Development and execution of Model Informed Drug Development (MIDD) plans, involving planning and execution of quantitative analyses which may include population pharmacokinetics, pharmacokinetics (PK)/pharmacodynamics (PD), exposure response, disease progression modeling, model-based meta-analysis, clinical trial design simulations, and quantitative systems pharmacology (QSP) modeling
• Drive the implementation of pharmacometric principles and practices
• Provide pharmacometric 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
• Experience applying appropriate FDA, EMA, and ICH guidelines in the design of MIDD plans and analyses, and preparation of pharmacometrics components of regulatory submissions and inquiries.
• Mentoring and/or supervision of junior staff to perform above duties and support career development
• Thrives in a fast-paced business environment

Qualifications:

• 5+ years of postdoctoral experience in quantitative pharmacology/pharmacometrics in the biotech and/or pharmaceutical industry
• Prior experience in the development and application of quantitative methods in drug development
• Strong hands-on modeling and simulation skills using NONMEM, R, and/or other modeling and simulation software.  Experience with population PK models, advanced mechanistic PK/PD models, disease models, PBPK models is highly preferred
• Proven track record in 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

Education:

• PhD in a quantitative science (e.g., statistics, mathematics, engineering, physics, computer science) or Pharm D

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.

Notice to Agency and Search Firm Representatives:

Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.