Description

Senior Pharmacokineticist

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

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 accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know: 
WORK HERE MATTERS EVERYWHERE

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 our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. 
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

Job responsibilities

We are seeking a highly skilled and motivated Senior Pharmacokineticist to join our dynamic team at Syneos Health. In this pivotal role, you will use your expertise in pharmacokinetics (PK) and pharmacodynamics (PD) to shape drug development strategies and contribute to impactful decision-making. You will collaborate with cross-functional teams, provide scientific leadership, and advance innovative analyses that guide the development of novel therapies. If you are passionate about driving scientific excellence and making a difference in global healthcare, we want to hear from you. 

• Key Responsibilities:

  • Lead Scientific Expertise: Serve as a trusted resource and thought leader in pharmacokinetics and pharmacodynamics, providing technical guidance to internal teams and external clients. You will play a key role in driving the success of drug development programs.

  • Data Analysis & Interpretation: Utilize advanced analytical techniques to calculate pharmacokinetic parameters and conduct complex statistical analyses of bioanalytical and clinical/nonclinical data. Your insights will directly influence key decisions and strategic directions.

  • Report Writing: Take ownership of writing and reviewing detailed pharmacokinetic and statistical sections of clinical and nonclinical reports. Your ability to clearly interpret and present complex results will be critical to successful regulatory submissions.

  • Regulatory Expertise: Provide expert guidance in addressing deficiency letters from regulatory agencies regarding pharmacokinetic and statistical analyses. Ensure compliance with regulatory standards and contribute to the smooth submission process.

  • Collaborative Consultancy: Share your scientific insights with colleagues across the company and externally, offering expertise on study design, analysis, and optimization strategies to ensure high-quality study execution.

  • Study Design and Optimization: Review and refine study protocols, ensuring they meet regulatory standards and industry best practices. You'll leverage both internal and external data to optimize study designs for maximum impact.

  • Standard Operating Procedures: Develop and review Standard Operating Procedures (SOPs) related to PK/PD processes, ensuring consistency and excellence in all methodologies and analyses.

  • Cross-Functional Collaboration: Partner with pharmacometricians, statisticians, and clinical experts to integrate knowledge of PK, PD, efficacy, safety, and other critical factors to influence the development of successful therapies.

  • Quality Assurance: Conduct thorough peer reviews and quality control checks to ensure the highest standards of analysis and reporting across all pharmacokinetic and pharmacodynamic work.

  • Data Analysis Planning: Collaborate with statisticians and pharmacometricians to create and execute detailed data analysis plans that align with project objectives and regulatory requirements.

Qualifications

What We're Looking For:

• Education: B.Sc. or M.Sc. in Biopharmaceutical Sciences, Pharmacology, Experimental Medicine, or a related field.

• Experience: Extensive experience in clinical trials, with a proven track record of progressively increasing responsibilities. 5+ years of experience in pharmacokinetics is highly preferred.

• Expertise: Deep understanding of the drug development process, regulatory guidelines, and industry standards for pharmacokinetics and pharmacodynamics.

• Technical Skills: Proficiency in pharmacometrics design and analysis, along with solid programming skills. Experience with software tools such as Phoenix WinNonlin is a plus, and knowledge of R programming is highly desirable.

• Communication Skills: Exceptional verbal and written communication skills, with the ability to clearly present complex technical information to both technical and non-technical stakeholders. Strong experience in technical report writing and procedure documentation is essential.

• Interpersonal Skills: Excellent interpersonal and presentation skills, with the ability to engage and influence colleagues, stakeholders, and clients effectively in a collaborative, fast-paced environment.

Preferred Background:

• Experience: Candidates with experience in a similar role within a Contract Research Organization (CRO), pharmaceutical company, or academic setting will be given priority.

• Role: Those currently in or previously holding a Senior Pharmacokineticist or similar position are strongly encouraged to apply.

• Technical Skills: Familiarity with Phoenix WinNonlin and R programming is highly desirable and will give you an edge.

Why Join Us?

• Impactful Work: As a Senior Pharmacokineticist at Syneos Health, you'll make a real difference in the development of groundbreaking therapies that impact global health.

• Innovation and Collaboration: You'll be part of an innovative and highly collaborative environment, working with leading experts and making significant contributions to cutting-edge research and development.

• Career Growth: At Syneos Health, we are committed to your professional development. With vast opportunities for training, mentorship, and career advancement, you'll be empowered to continue growing your expertise and leadership in pharmacokinetics.

Get to know Syneos Health
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. Learn more about Syneos Health.

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.

AtSyneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance.  The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time.  Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

The annual base salary for this position ranges from $72,540 to $145,000.  The base salary range represents the anticipated low and high of the Syneos Health range for this position.  Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.