Our Quantitative Sciences team use big data to analyze the safety and efficacy claims of our potential medical breakthroughs. We review the quality and reliability of clinical studies using deep scientific knowledge, statistical analysis and high-quality data to support decision making in clinical trials.
Position Description:
Therapeutic area Senior Directors in Quantitative Pharmacology and Pharmacometrics (QP2) are responsible for driving integrated end-to-end discovery through development portfolio decisions for multiple disease areas within a therapeutic area and for the performance, talent and resource management of their team.
This role oversees an extensive portfolio in the cardiovascular, metabolic disease and ophthalmology therapeutic areas (CMD) that has experienced significant growth through internal research and business development, and includes multiple assets moving through near-term late development milestones. The CMD Senior Director is responsible for driving the portfolio forward leveraging the full strength of the QP2 department while also being responsible for talent development and staff performance management.
In addition, Senior Directors represent QP2 and provide critical strategic input on cross-functional committees and task forces, with leadership and active contributions to one or more business or talent facing workstreams. They are recognized as emerging external scientific thought leaders that develop and implement translational PK/PD strategies, characterize clinical pharmacokinetics and pharmacodynamics of small molecules, biologics and novel modalities, and inform dose selection and go/no-go decisions.
As the Senior Director for the CMD therapeutic area, you will be responsible for providing strategic leadership and talent management for the department through:
Leading a team of 10-12 QP2 scientists including people management, scientific and operational oversight, under the direction of the Executive Director of CMD, Infectious Disease and Vaccines
Leveraging end-to-end drug discovery/development and disease area expertise to independently provide day-to-day scientific oversight to individual contributors
Maintaining a comprehensive understanding of global regulatory expectations for small molecules, biologics and novel modalities, authoring and reviewing regulatory documents (INDs, CSRs, CTDs), and representing QP2 at regulatory meetings
Setting priorities for direct reports and driving performance management, hiring and retention, staff development and training, and input into calibration and talent management processes
Improving the diversity of our teams, ensuring equity of opportunity and an inclusive workplace
Identifying resource needs and contributes to resource allocation internally and through management of business operations including travel and outsourcing budgets
Working with QP2 leadership to contribute to the development and execution of departmental priorities and ensure broad alignment of individual priorities/performance of team with the QP2 vision/mission
Providing functional representation on committees, task forces or initiatives spanning beyond QP2
The Senior Director is an experienced quantitative drug developer and people manager, with a strong, integrated understanding of the strategic elements of drug discovery and development. The selected candidate will develop strategies for quantitative analyses (and commensurate experiments/trials) within and across discovery and development programs in the cardiovascular and metabolic disease therapeutic area. In addition to the responsibilities described above, Senior Directors demonstrate outstanding leadership and communication skills collaborating across QP2 and with other functional areas, as well as with external vendors and partners to create a quantitative model-informed approach to impact program strategies and decision making on drug development teams.
Position Qualifications :
Education Minimum Requirement:
Ph.D. or equivalent degree with at least 10 years of discovery, drug development and/or regulatory experience
Required Experience and Skills:
Demonstrated track record in establishing an inclusive and high-performance work environment through building talent, fostering collaboration and driving results while managing through ambiguity, including at least 2 years of management experience
Extensive experience in developing quantitative strategies for impacting pipeline decisions, direct experience in regulatory interactions and filings, and drug development expertise in cardiovascular or metabolic disease
Preferred Experience and Skills:
Expert skills in performing population PK/PKPD analyses using standard pharmacometric software (e.g. NONMEM, R, Monolix, Phoenix, etc.)
Advanced scientific understanding of biopharmaceutical and ADME properties for both small molecules and biologics
Proficiency in written and verbal communication, interdisciplinary collaboration, and problem scoping and planning, with a demonstrated ability to participate in and lead interdisciplinary teams
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
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Who we are ...
We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for ...
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us-and start making your impact today.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Residents of Colorado
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For positions located in the United States and Puerto Rico - Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) ("Customer-Facing Role") who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.
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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.
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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Under New York City, Washington State and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. 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 salary range: $193,440.00 - $304,500.00 For Washington State Jobs, a summary of benefits is listed here .
Learn more about your rights, including under California, Colorado and other US State Acts
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: Regular
Relocation: Domestic/International
VISA Sponsorship: Yes
Travel Requirements:
Flexible Work Arrangements: Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings: 1
To apply please click on APPLY TO THIS POSITION
Job Post Date: 01/25/23
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