Associate Director, Quantitative Pharmacology and Pharmacometrics Cardiometabolic and Ophthalmi[...]

Fenningham, Dempster & Coval LLP; West Point (AL); Hybrid; USD 153,000 - 243,000; Full time

Job summary

A biopharmaceutical company seeks an Associate Director in Quantitative Pharmacology to support cardiometabolic and ophthalmologic disease development. This role requires a strong background in drug development, collaboration with diverse teams, and expertise in quantitative drug modeling, aimed at accelerating therapeutic advancement.

Benefits

Bonus eligibility

Healthcare benefits

Retirement benefits

Paid holidays

Vacation and sick days

Qualifications

• Ph.D. with at least 4 years, PharmD with at least 6 years, or MS with at least 8 years of experience.
• Background in biopharmaceutics or related field.
• Experience with pharmacometrics software.

Responsibilities

• Develop model-based strategies for quantitative analyses.
• Represent QP2 on cardiometabolic and ophthalmology teams.
• Collaborate on study design and execution.

Skills

Quantitative drug development

Collaborative work spirit

Excellent communication skills

Education

Ph.D. or equivalent degree

MS or equivalent degree

Job description

Associate Director, Quantitative Pharmacology and Pharmacometrics Cardiometabolic and Ophthalmic Diseases

To be considered for this opportunity please apply to this posting (R345086) via the Merck Career site as Jobs.Merck.com

The Quantitative Pharmacology and Pharmacometrics (QP2) Department of our Company's Research Laboratories in West Point, PA / Rahway, NJ is seeking a curious and collaborative Associate Director to support our rapidly expanding cardiometabolic and ophthalmology pipelines.

As an Associate Director, you will represent QP2 on cross-functional teams of experienced scientists to discover and advance the clinical development of novel therapeutic agents for cardiometabolic and ophthalmologic diseases. You will work on the discovery and development of small molecules, biologics and non-traditional therapeutics like peptides, novel biological constructs, and others. The Associate Director is a skilled quantitative drug developer, with a strong, integrated understanding of the strategic elements of drug discovery and development. The Associate Director should demonstrate collaborative work spirit and excellent communication skills and should work independently with minimal supervision.

Within QP2, you have a unique opportunity to accelerate your professional career as a quantitative drug developer taking advantage of our end-to-end pipeline support in one of the world’s most research-intensive biopharmaceutical companies.

Responsibilities:

• Develop model-based strategies (translational PK/PD strategies, mechanistic model, POPPK/PD, clinical trial simulations, etc) for quantitative analyses, within and across development programs and/or departments, to inform and optimize drug discovery and all phases of drug development including, but not limited to dose selection, clinical trial design, and go/no-go decisions.
• Represent QP2 on cardiometabolic and ophthalmology discovery, early clinical development and late clinical development teams, leveraging quantitative approaches to drive streamlined development of programs within our growing ophthalmology portfolio.
• Collaborate with other functional areas, as well as with external vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug discovery and development teams.
• Collaborate with other functional areas, as well as with external vendors and partners, on activities related to study design, protocol development, study execution, reporting and interpretation of data.
• Maintain a comprehensive understanding of global regulatory expectations and shape, present and defend regulatory documents and submissions.
  Work closely with pharmacometrics team members and provides input related to analysis and reporting of modeling activities.

Required Qualifications:

• A Ph.D. or equivalent degree with at least 4 years of experience OR a PharmD or equivalent degree with at least 6 years of experience OR an MS or equivalent degree with at least 8 years of experience, where “experience” means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development, regulatory agency, or academia
• Educational background in biopharmaceutics, pharmaceutical sciences, pharmacometrics, chemical/biomedical engineering, or a related field
• Experience in performing population PK/PKPD analyses using standard pharmacometrics software (e.g. NONMEM, Monolix, Phoenix, etc.)
• Proficiency in written and verbal communication, interdisciplinary collaboration, and problem scoping and planning
• Knowledge in modeling of complex therapeutics

Preferred Qualifications:

• Knowledge in cardiometabolic and/or ophthalmology clinical drug development programs
• Expert skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics
• Scientific understanding of biopharmaceutical and ADME properties of small molecules and/or biologics
• An exemplary record of increasing responsibility, independence, and demonstrated impact in driving drug development decisions through application of model-based approaches

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here on our career site if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

U.S. Hybrid Work Model:

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected US salary range:

$153,800.00 - $242,200.00

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.