Executive Director, Drug Metabolism and Pharmacokinetics

4 weeks ago


Arvada, Colorado, United States Merck Full time

Job Description

The Pharmacokinetics, Dynamics, Metabolism and Bioanalytics (PDMB) department, is seeking an Executive Director to lead the Drug Metabolism and Pharmacokinetics (DMPK) team in West Point, PA. The leader of this group will have broad responsibilities in three interconnected areas – pipeline, talent, and strategy, and will be responsible for supporting the Neurosciences and Infectious Diseases discovery pipeline as well as a broad portfolio of programs at various stages of development across various therapeutic areas.

The our company's DMPK Executive Director will enable the execution of the broad PDMB strategy and DMPK priorities including implementation of dynamic research operating plans (ROPs), translational and dose optimization strategies, and participation in therapeutic area-driven strategic discussions. The successful candidate will also contribute to the alignment of departmental and portfolio priorities within the company's strategic framework. To achieve this, they will lead a team of talented scientists and partner with cross-functional stakeholders. Key deliverables include stage appropriate portfolio decisions, advancing lead identification, translational strategy, clinical candidate selection, starting clinical dose, assessing drug interaction risk and contributing to regulatory filings.

As a member of the DMPK Leadership team, the Executive Director will contribute to global scientific and portfolio strategy, talent development and will be responsible for site-specific business and operational aspects. They are expected to demonstrate exemplary ways of working, strong ethics, good negotiation skills and an enterprise mindset.

Key responsibilities:

  • Accountable for strategic planning and scientific oversight of the discovery and development portfolio supported by the our company's team.
  • Responsible for resourcing and execution of mechanistic studies and the design of stage appropriate experiments in support of a pipeline consisting of diverse modalities and therapeutic mechanisms of action.
  • Responsibilities range from early discovery through registration and life cycle management
  • Oversight of a highly trained group of scientists that provide support for the global pipeline, including Absorption, Distribution, Metabolism and Excretion (ADME), In Vitro Enzymology and Transporter as well as biotransformation data, including state-of-the-art capabilities
  • Partner closely with peers across the DMPK organization and with key PDMB and cross-functional stakeholders to identify and implement experimental and modeling solutions to progress programs and platforms
  • Advance the use of In Silico tools and modeling techniques to accelerate lead optimization/selection and the progression of clinical candidates with high probability of success
  • Oversee and participate in regulatory activities, including preparation of robust, fit for purpose submission packages based on deep understanding of regulatory expectations
  • Adjust and prioritize internal and external resources to efficiently support a rich and evolving pipeline for timely portfolio decision making and program progression
  • Contribute as functional area representative to governance committees ensuring that PDMB support aligned with portfolio objectives
  • Actively attract, develop, and retain talent
  • Collaborate with members of the Global DMPK leadership team to manage operational and financial aspects of the business. As member of the PDMB extended leadership team, contribute strategic discussions and execute on PDMB priorities
  • Demonstrate and foster a quality and compliance mindset
  • Participate in licensing evaluations

Qualifications

Required:

  • PhD with 10+ years relevant experience in a biopharmaceutical discovery and development organization.
  • Experience in implementing effective ROPs, applying In Silico and experimental approaches in the discovery
  • Ability to manage a broad portfolio, including small molecules, peptides and biologics.
  • Command of ADME and PK/PD science to effectively address mechanistic and strategic questions related to efficacy and safety in relation to human exposure to influence program strategies, guide therapeutic design and candidate selection, and implementation of effective de-risking plans.
  • Experience in building, leading, and managing teams with diverse experience and background to drive innovation and scientific excellence.
  • Strong decision-making skills with an ability to focus on key objectives and forecast portfolio needs.
  • Clear ability to mentor and develop as part of talent development, succession planning and fostering of a positive culture.
  • Demonstrated strong leadership, interpersonal, collaboration and communication skills and an enterprise mindset.
  • Knowledge in the areas of infectious and Central Nervous System (CNS) diseases is desirable.
  • Evidence of scientific achievement as demonstrated by a strong publication record.

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.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

Pay Transparency Nondiscrimination

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.

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, generally Tuesday, Wednesday and either Monday or 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".

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:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

09/6/2024

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

Job Posting End Date:09/06/2024

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

Requisition ID:R308615



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