Principal Scientist, Early Device Program Strategy and Due Diligence

Job Description

Position Description:

Early Device Program Strategy and Due Diligence

The Principal Scientist of Early Device Program Monitoring & Due Diligence will play a pivotal role in leading and coordinating diverse activities between various device and combination product development, discovery, and formulation development teams.

This involves managing a small team of engineers and participating in critical early-phase program direction setting for the delivery device of drug candidates advancing through the pipeline. In addition, this position will participate as device and drug-device combination product SME in due diligence assessments of prospective drug candidates entering from licensing and acquisition channels. The successful candidate will adeptly handle the following key responsibilities:

Team Leadership and Interface Management :

Manage a small team of engineers to serve as interfaces between the delivery device development team and upstream drug and formulation development teams.

Construct initial overall development strategies, timelines, and transition plans into fully commissioned Device Working Groups.

Engage with early-phase and pre-clinical drug development teams, conduct initial device-ability assessments, and perform platform fit/suitability assessments.

Establish the business case justifying full device development and clear target product profile elements.

Establish resource plans and monitor lifecycle management opportunities for assets currently in development.

Evaluate delivery device technology, including freedom to operate (FTO) and intellectual property (IP) considerations in collaboration with the Legal department.

Business Development and Due Diligence :

Serve on Business Development and Licensing (BD&L) due diligence assessments for assets and acquisition targets under consideration.

Mentor team members conducting similar due diligence activities.

Collaboration and Partnerships :

Collaborate effectively with downstream Device Development and Technology groups to ensure efficient and seamless product and knowledge transfer.

Collaborate with clinical and marketing colleagues to design product profiles for prospective combination product programs, ensuring alignment with the broader product development and commercialization strategies.

Strategic Planning and Execution :

Provide strategic leadership in the development of medical devices and drug-device combination products, aligning with the companys overall business strategies and goals.

Drive the development and implementation of strategies for device technology selection, clinical evaluation, early combination product development, and regulatory compliance.

Position Qualifications :

Education Minimum Requirement:

Bachelors Degree

Required Experience and Skills:

Minimum 10 years’ experience working within the drug-device combination product and formulation development areas within a pharmaceutical or biotechnology company.

In-depth understanding of early-phase drug development, including formulation science, preclinical and clinical research.

In-depth knowledge of medical device development, regulatory requirements, and quality standards, with a knowledge of the requirements in successfully bringing medical devices and drug-device combination products to market.

Experience in business development, due diligence assessments, and strategic partnerships in the pharmaceutical or medical device industry.

Ability to inspire, mentor, and develop team members.

Excellent communication and interpersonal skills, with the ability to collaborate effectively across diverse functional areas and external partners.

Degree(s) in relevant scientific, engineering, and business discipline

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 (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

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 (https://survey.sogosurvey.com/r/aCdfqL) 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 (https://www.eeoc.gov/sites/default/files/2022-10/22-088EEOCKnowYourRights1020.pdf)

EEOC GINA Supplement​

Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp%20EnglishformattedESQA508c.pdf)

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 (https://www.msdprivacy.com/us/en/CCPA-notice/)

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”.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. 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 US salary range:

$149,400.00 – $235,100.00

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here (https://www.benefitsatmerck.com/) .

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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

10/25/2024

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: 10/25/2024

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: R314814