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Director, Clinical Data and Submission Readiness Product Line Lead
vor 3 Monaten
Job Description
At our company, we have a rich history of inventing life-changing medicines and vaccines. Information technology is a crucial element in our success, enabling us to effectively collect, analyze and report on clinical trial data and bring innovative therapies to patients.
As a Product Line Lead, you will play a critical role in setting the vision for best-in-class products and ensuring the successful implementation of the product strategy in the Clinical Data Management and Submission space. You will be responsible for establishing the technical vision, principles, and standards for the product line, ensuring a modern and exceptional technology experience for our users.
This individual will work closely with stakeholders from our research division, including Global Data Managements and Standards and Bios teams, to help our clinical organization reduce time needed to bring innovative products to market while ensuring the quality and timeliness of our clinical data.
Responsibilities:
Vision and Strategy:
- Set the vision and strategy for the Clinical Data and Submission Readiness product line, aligning it with the overall business objectives of the organization.
- Establish technical principles and standards to guide the development and implementation of products within the product line.
Product Management:
- Take end-to-end responsibility for all products in the Clinical Data and Submission Readiness product line, including strategy, roadmap, total cost of ownership, user satisfaction, and product quality.
- Collaborate with stakeholders to shape and design IT solutions that meet the needs of users and downstream consumers, driving business value while removing redundancy
- Oversee the delivery and operations of applications in the product line, ensuring seamless data flow and integration with other systems.
- Define and plan product roadmap and new product platform launches within the product line.
- Seek opportunities to simplify end-to-end processes by interfacing multiple products.
- Apply specialized skills such as methods and tools, benefits management, systems development management, information systems coordination, stakeholder relationship management, enterprise and business architecture, problem management, product management, and strategic planning.
Relationship Management and Collaboration:
- Manage relationships with enterprise teams and vendor partners to ensure effective collaboration and alignment on product-related initiatives.
- Work closely with our research division's Clinical Data Management and Downstream Data Consumers to ensure frictionless data flow and effective utilization of data for clinical trial activities.
Leadership and Talent Development:
- Lead and inspire a team, providing guidance and mentorship to both product and technical roles.
- Drive organizational change and cultivate a culture of excellence, innovation, and collaboration.
- Develop talent through coaching and mentoring, ensuring technology excellence is embedded in all activities.
Requirements:
- Minimum of 8+ years of relevant experience in technology, product management, preferably in the healthcare or pharmaceutical industry.
- Proven track record of successfully leading product strategy, roadmap design, and development.
- Extensive knowledge of current technologies, with recent demonstrated hands-on experience.
- Strong leadership, communication, and collaboration skills to effectively work with stakeholders and cross-functional teams.
- Experience in managing product and people, driving organizational change, and fostering a culture of excellence.
- Experience with agile product management methodologies and tools.
- Knowledge of clinical research, biostatistics or real-world evidence and experience with supporting technology implementations .
Preferred Experience:
- Familiarity with industry regulations and standards related to healthcare, clinical data collection, analysis, and submission.
- Experience with data solutions using modern Cloud infrastructure (AWS, Azure).
- Understanding of regulatory requirements that drive IT delivery, including 21-CFR-Part-11, Annex 11, Good Laboratory and Clinical practices, Computer Systems Validation, and other global regulatory requirements that impact IT systems in the R&D space.
Current Employees apply HERE
Current Contingent Workers apply HERE
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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:
RegularRelocation:
VISA Sponsorship:
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Flexible Work Arrangements:
HybridShift:
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Job Posting End Date:
08/18/2024*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:08/18/2024
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:R305085