Group Leader Senior Director, Quantitative Pharmacology and Pharmacometrics (Hybrid or Remote)

Job Description

This role provides strategic leadership and scientific oversight to part of the cardiometabolic (CMD) therapeutic area (TA) portfolio in the department of Quantitative Pharmacology and Pharmacometrics (QP2). The Team Leader (Senior Director) is responsible for application of cutting-edge quantitative pharmacology and pharmacometrics strategies to propel the internal portfolio forward leveraging the full strength of the QP2 department. The CMD TA Team Leader will be tasked with overseeing a team of QP2 scientists providing guidance in personnel management scientific strategy and operational execution in addition to serving as QP2 lead on assigned projects. Reporting directly to the QP2 CMD Head and serving as their delegate when needed the individual will collaborate closely with the QP2 CMD leadership team and broader organization to ensure consistent high-value quantitative pharmacology contributions throughout the CMD portfolio from discovery through life cycle management. This role is also part of the extended QP2 leadership team and expected to bring leadership and active contributions to one or more business or talent facing workstreams. Senior Directors are recognized as scientific thought leaders that develop and implement translational PK/PD strategies characterize clinical pharmacokinetics and pharmacodynamics and shape regulatory strategy dose selection and go/no-go decisions.

Responsibilities

• Leading a team of up to 4 QP2 scientists including people management scientific and operational oversight under the direction of the Executive Director of QP2- CMD

• Leveraging end-to-end drug discovery/development and disease area expertise to independently provide day-to-day scientific oversight to individual contributors

• Setting priorities for direct reports and driving performance management hiring and retention staff development and training and input into calibration and talent management processes

• Serving as an expert representative for QP2 on discovery and drug development teams and engaging in cross-functional and governance discussions including business development and licensing evaluations

• Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics contributing to cross-functional regulatory strategy authoring regulatory documents (INDs CSRs CTDs)

• Developing and applying mechanistic disease progression and comparator modeling platforms to help drive portfolio decisions

• In partnership with Executive Director of CMD identify resource needs and contributes to resource allocation internally.

• Serve as QP2 lead on assigned projects

Required:

• Ph.D./PharmD or equivalent degree with at least 10 years of experience where experience means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development or regulatory.

• Educational background inbiopharmaceutics pharmaceutical sciences pharmacometrics chemical/biomedical engineering mathematics statistics/biostatistics computational biology/chemistry or a related field

• Extensive experience in developing quantitative strategies for impacting pipeline decisions and drug development expertise

• Demonstrated ability to lead an interdisciplinary team or taskforce and/or to oversee the work of others

• Record of ability to operate in an inclusive and high-performance work environment applying enterprise ways of working principles including fostering collaboration and driving results while managing ambiguity

• Relevant regulatory and quantitative pharmacology experience

• Proficiency in written and verbal communication interdisciplinary collaboration and problem scoping and planning

Preferred:

• CMD Therapeutic area or disease knowledge

• Expert skills in performing population PK/PKPD analyses using standard pharmacometrics software (e.g. NONMEM R Monolix Phoenix etc.)

• Scientific understanding of biopharmaceutical and ADME properties across modalities

• Record of applying models to inform decisions

• Ability to influence regulatory strategies including prior experience independently authoring and defending regulatory filings for marketing authorization (NDA/MAA)

• Recognized leader in the field of quantitative pharmacology with a track record of sustained external visibility through publications presentations and/or involvement in professional organizations

The remote position is only applicable for those that are not within commutable distance to primary sites noted in posting. If commutable the position will be hybrid. Please note that standard commute is (less than) <50 miles.

#QP2

#EligibleforERP

Required Skills:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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 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 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:

EEOC Know Your Rights

EEOC GINA Supplement

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 anothers thinking and approach problems collectively.

Learn more about your rights including under California Colorado and other US State Acts

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 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 salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.