Job Description

Job Description

Brief Description of Position

Translational Medicine is responsible for early clinical development of novel therapeutics, working in close collaboration with Immunology Discovery Sciences and late-stage Immunology Clinical Research. We work with all therapeutic areas within our Research Division with the role focused on Immunology. Clinical Directors must have a strong background in basic and/or clinical translational research and a desire to work collaboratively across different therapeutic areas.

Translational Medicine is specifically responsible for:

• Leadership of the early clinical development strategy for novel therapy programs from Preclinical Candidate approval through Clinical Pharmacology testing (Phase 1), and clinical Proof-of-Concept (Phase 2).

• Development of biomarker strategies through cross-functional teams that provide line-of-sight from First-in-Human studies through clinical Proof-of-Concept. This includes Experimental Medicine studies to establish and/or validate biomarker platforms.

• Contributing to the identification of novel targets by partnering with discovery research teams to bring a clinical perspective into the earliest stages of target identification and validation, and executing clinical studies to evaluate the relevance of potential targets to human disease in order to justify investment in clinical development programs.

• Development and execution of clinical pharmacology strategies to support later stages of development from Proof-of-Concept (Phase 2) through worldwide marketing application.

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 in Translational Medicine, as well as Discovery Sciences and late-stage Clinical Research while developing and expanding your career.

Primary responsibilities include the following:

• Key member of an early development team, providing leadership in designing and executing early clinical development strategy.

• Development and execution of early clinical strategy for novel therapeutics including authoring initial clinical and biomarker plans for Lead Optimization programs, early clinical development plans for Preclinical Candidate molecules, and clinical pharmacology studies for programs in Phases I through IV of development.

• Development and execution of studies to validate clinical platforms utilizing established and novel biomarkers, including imaging, electrophysiological and behavioral responses to interrogate biological activity in humans.

• Provide clinical expertise for identification and validation of novel targets, including the design of preclinical and/or clinical pharmacology experiments to validate targets and/or pathways.

• Safe and timely execution of Phase I studies; close collaboration with internal and external clinical study support staff and scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations).

• Provide clinical pharmacology 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 therapeutic area governance, functional area experts and development review committees.

• Contribute to assessment of internal and external opportunities identified by Business Development and Licensing.

• Interface broadly with key functions including Discovery Sciences, Preclinical Pharmacology, Pharmaceutical Sciences, Toxicology, Translational Biomarkers, Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs, and late-stage Clinical Research throughout research sites around the world.

Division/Area

Clinical Research

Extent of Travel

25%

Qualifications, Skills & Experience

Education:

• MD or MD/PhD

Required:

• Proven track record in clinical medicine or clinical research, and background in biomedical research.

• Demonstrated record of scientific scholarship and achievement including publications or presentations. The particular clinical or scientific background is less important than having a track record of excellence and a 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.

Preferred:

• Clinical Board Certification or Eligibility.

• Prior experience in translational research and/or early clinical development preferred but not required.

• Proven track record in clinical care of patient populations or management of clinical problem-solving

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 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 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 employee’s 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 .

You 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]]> <

Job Tags

Similar Jobs