Scientific AVP, Clinical Research Job

Scientific AVP, Clinical Research-CLI005337

Description

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.


Translational Pharmacology is a group within Merck Research Labs that is seeking a qualified leader to help execute its enhanced strategy on end-to-end drug development. Translational Pharmacology is responsible for:

- Development and execution of the early development clinical strategy for a given program from preclinical candidate approval through proof-of-concept

- Development of biomarker strategies through cross-functional teams that provides line-of-sight from first-in-human studies through proof-of-concept

- Development and execution of clinical pharmacology strategy for a given program from proof-of-concept through the worldwide marketing application.

- Identification of novel targets by thinking creatively to bring new targets or platforms into development. This involves partnering with the basic research teams to bring a clinical perspective into the earliest stages of development, and executing on clinical studies that can be bridged into full development.

- Translational Pharmacology’s ability to excel and differentiate 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 have the opportunity to collaborate with talented and dedicated colleagues in Discovery Sciences and Clinical Research while developing and expanding your career.

This position will report directly to the Head of Translational Pharmacology.

Primary responsibilities will include the following:

- Key member of early development teams, providing a leadership role with regard to design and execution of early clinical development strategy.

- Development and execution of the early clinical strategy for a given program including authoring initial program clinical plans, the early development and biomarker plans and, clinical pharmacology studies Phase 1 through Phase 4. The clinical program may include studies to validate clinical platforms utilizing established and novel biomarkers to demonstrate biological activity in humans.

- Timely and safe execution of Phase I studies; interact closely with internal and external clinical study support staff and scientists (including discovery research, biostatistics, drug metabolism, 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.

- Provide clinical expertise for Discovery targets in the Target Identification, Target Validation and Lead Identification space including participation in the selection of targets and the design of preclinical pharmacology experiments to validate specific targets and/or pathways

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

- Interface broadly with key functions including Discovery, Preclinical Pharmacology, Pharmaceutical Sciences, Toxicology, Translational Biomarkers, Drug Metabolism/Modeling & Simulation, Regulatory Affairs, Clinical Research

Qualifications

Education Minimum Requirement

- MD or MD/PhD; Board Certification or Eligibility is preferred

Required:

- At least 15 years of academic or industry experience

- Strong leadership skills

- Demonstrated capability for people management/development

- Proven track record in clinical medicine, biomedical research, and end-to-end drug development.

- Demonstrated record of scientific scholarship and achievement in clinical and/or basic research, translational medicine and/or early drug development.

- Demonstrated accomplishment in regulatory submission, senior management presentation of nuanced data, fostering creativity, and problem solving.

- Strong interpersonal, writing and presentation skills, as well as the ability to function in a team environment are essential.

Preferred:

- Preferably board certified

- Prior specific experience in clinical research and prior publication is desirable; preferably with documented experience in the area of basic, translational research and/or clinical development

- Evidence of accomplishment in areas of high relevance to the Merck pipeline is desirable

- Displays entrepreneurial mindset and collaborates effectively with internal/external stakeholders.

- Has ability to use creative and innovative solutions, and works with patience and perseverance to deliver results that can be evaluated for further investment

Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at staffingaadar@merck.com.

Search Firm Representatives Please Read Carefully:

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

Visa sponsorship is not available for this position.

For more information about personal rights under Equal Employment Opportunity, visit:

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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.


Job: Clinical Research (M.D.)

Job Title:Scientific AVP, Clinical Research

Primary Location: NA-US-NJ-Rahway

Employee Status: Regular

Travel: Yes, 20 % of the Time

Number of Openings: 1

Company Trade Name:Merck