Senior Pharmacokineticist

1200 Syneos Health Clinique Inc.; India; Remote; INR 1,800,000 - 2,400,000; Full time

Job summary

Syneos Health seeks a Senior Pharmacokineticist to lead complex PK/PD analyses, interpret data across clinical and nonclinical studies, and support regulatory interactions. The role emphasizes collaboration with pharmacometricians and cross-functional teams to drive drug development decisions.

Based in India, you will leverage validated software to analyze bioanalytical and clinical data, write study sections, and contribute to quotation processes for area activities.

Qualifications

• Act as a scientific and technical resource in PK/PD analyses.
• Calculate PK parameters and perform statistical analyses on study data.
• Prepare PK/PD sections of clinical and nonclinical reports.
• Contribute to consultancy and regulatory interactions.

Responsibilities

• Act as a scientific and technical resource person within Syneos Health for PK/PD fields.
• Calculate pharmacokinetic parameters and perform statistical analyses on data using validated software.
• Write PK/PD sections of clinical or nonclinical reports with interpretation.
• Participate in internal/external scientific consultancy.
• Respond to deficiency letters from regulatory agencies on analyses.

Skills

Pharmacokinetics

Pharmacodynamics

Statistical analysis

Clinical pharmacology

Bioanalytical data interpretation

Tools

NONMEM

Job description

Senior Pharmacokineticist Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.

Discover what your 25,000 future colleagues already know: Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself.
• We are continuously building the company we all want to work for and our customers want to work with.

Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities

• Act as a scientific and technical resource person within Syneos Health for the pharmacokinetics and pharmacodynamics fields and perform complex pharmacokinetic and/or pharmacodynamic analyses.
• Calculate pharmacokinetic parameters and perform statistical analyses on bioanalytical and clinical (or nonclinical) data using tested or validated software
• Write the pharmacokinetic and statistical sections of clinical (early and late phases) or nonclinical (toxicokinetic studies) reports including interpretation of the results
• Participate in intra and/or extra company scientific consultancy
• Answer to deficiency letters from regulatory agencies on the conduct of the pharmacokinetic and statistical analyses performed during clinical studies
• Participate to the quotation process for the functional area activities using internal database, literature data and pricing grid
• Review study protocol in accordance with regulatory requirements using internal and/or literature data, and design information appearing in inhouse database.
• Write/review standard operating procedures related to his/her work
• Use quantitative approaches to integrate knowledge of PK, PD, efficacy, safety, patient demographics, and pathophysiological factors to facilitate product development and decision making under the supervision of pharmacometricians
• Participate in the development of structured and standardized data modeling practices and related SOPs
• Act as a consultant in clinical pharmacology study design development (e.g., optimal sampling, protocol review, etc.)
• Perform comprehensive quality control/peer review procedures
• Act as a scientific and technical resource person within Syneos Health for the pharmacokinetics and pharmacodynamics fields and perform complex pharmacokinetic and/or pharmacodynamic analyses.
• Calculate pharmacokinetic parameters and perform statistical analyses on bioanalytical and clinical (or nonclinical) data using tested or validated software
• Write the pharmacokinetic and statistical sections of clinical (early and late phases) or nonclinical (toxicokinetic studies) reports including interpretation of the results
• Participate in intra and/or extra company scientific consultancy
• Answer to deficiency letters from regulatory agencies on the conduct of the pharmacokinetic and statistical analyses performed during clinical studies
• Participate to the quotation process for the functional area activities using internal database, literature data and pricing grid
• Review study protocol in accordance with regulatory requirements using internal and/or literature data, and design information appearing in inhouse database.
• Write/review standard operating procedures related to his/her work
• Use quantitative approaches to integrate knowledge of PK, PD, efficacy, safety, patient demographics, and pathophysiological factors to facilitate product development and decision making under the supervision of pharmacometricians
• Participate in the development of structured and standardized data modeling practices and related SOPs
• Act as a consultant in clinical pharmacology study design development (e.g., optimal sampling, protocol review, etc.)
• Perform comprehensive quality control/peer review procedures

Get to know Syneos Health

Learn more about Syneos Health. http://www.syneoshealth.com

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Discover what our Syneos Health colleagues already know: work here matters everywhere. Work alongside the brightest minds in the biopharmaceutical industry taking down walls and removing barriers to speed our customers’ delivery of important therapies to patients. We are strategic thinkers who actively seek different perspectives, whether across offices or across oceans. Because we solve some of the toughest challenges facing the most prestigious healthcare companies today, you'll gain exposure and be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. The diversification and breadth of Syneos Health creates a multitude of career paths and employment opportunities. We’re a growing, global company dedicated to advancing our talent past their initial role. Discover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world. Selecting us as an employer secures a career in which you’re guaranteed to: Partner with the most diverse team of experts in the industry. From the top down, our people are inspiring. Everyone has a voice and is encouraged to use it. Work in specialized Syneos Health teams that are therapeutically or functionally aligned for expert collaboration. We assemble clinical teams where everyone, from CRAs to senior management, is skilled in the same therapeutic area or customer teams. With this structure, everyone on your team speaks the same language and can deliver unique insights into the therapeutic environment and patient population. We are partners with purpose. We integrate seamlessly with our customers and do what’s best for their success. Our people provide the brilliant ideas, valuable insights and endless energy that accelerates the impact of life changing therapies worldwide.