Job details

Associate Director, Enterprise Applications (R&D Systems)

Get a free resume review

About the Role

As an Associate Director, Enterprise Applications – R&D Systems, you will act as a hands-on technology expert and IT system owner for Veeva clinical and regulatory platforms. You will collaborate closely with the respective business functions to lead the implementation and support of these systems and work closely with Quality and external vendors to support computerized system validations.

Let’s talk about some of the key responsibilities of the role:

Act as a subject matter expert and application lead for R&D, clinical, regulatory and quality business functions in biopharmaceutical environment
Lead and own IT roadmap and implementations for Clinical and Regulatory teams and be hands on technical expert with solution design, system configurations, testing and validation
Perform requirement gathering, risk assessment, impact assessment of new and existing systems
Collaborate with business stakeholders, IT and external vendors to prioritize and implement new business capabilities and provide day-to-day operations support for clinical and regulatory systems
Work with business stakeholders, vendors and quality teams to lead the implementation of Veeva clinical systems such as Vault EDC, CDB, RTSM and Veeva Vault RIM platform for regulatory function. Act as the IT system owner for these platforms
Collaborate with quality team and external vendors on GxP systems operations, Change management, CAPAs and computerized systems validation
Lead requirement gathering, solution design and user acceptance testing of system changes to ensure quality production deployments
Lead the implementation and support of Clinical data analytics solutions
Review and own IT activities for change control requests and provide all required documentations for clinical systems
Assist clinical team with data management, migration, and analytics for study related data in EDC
Collaborate with cross-functional teams and support the business stakeholders to identify and implement process improvements, enhancing system efficiency and effectiveness
Develop, review and update standard operating procedures (SOPs) and policies related to GxP systems

Factors for Success:

Bachelor’s degree in computer science, Information Systems, Engineering, Quality, Regulatory, or Business, with 12+ years of relevant IT experience
7+ years of relevant experience in architecting, implementing and supporting clinical and regulatory systems in a life sciences and pharma industry
Experience with business processes and System Development Lifecycle (SDLC) in a GxP regulated environment is a must
5+ years of relevant experience with implementing and supporting clinical and regulatory systems
Strong knowledge and hands on experience implementing Electronic Data Capture EDC and other clinical platforms and data management solutions, preferably with Veeva EDC and clinical platforms
Proficiency in configuring and maintaining Veeva vault applications
Strong knowledge in Regulatory operations and hands on experience implementing and supporting Regulatory management systems preferably Veeva Vault RIM system. Certifications in Veeva EDC, RIM will be a plus
Experience in implementing other clinical systems such as eTMF, CTMS and Payments solutions will be a plus
Good knowledge and experience in building and managing Cloud environments and building clinical data warehouse and visualization and dashboards using tools such as Spotfire, Tableau or PowerBI
Good understanding of technologies such as SQL, SOQL, REST, SOAP, HTML5, JavaScript, Python or R and supporting statistical tools such as Minitab and JMP
Stay updated on new technologies and trends, ensuring the company derives optimal value from both current and prospective solutions or technologies under consideration for adoption
Familiar with waterfall and/or Agile project management methodologies
Very good communication and problem-solving skills
Self-starter: able to work independently, proactively identify challenges, and be accountable
Experience in leading multiple vendors such as software providers, system integrators and managed services partner on projects and support

A Few Other Details Worth Mentioning:

The position will be based in our beautiful Irvine office, complete with a courtyard, snacks, drinks, and occasional catered meals. We provide a hybrid work environment
Remote will be considered, but preference will be given to onsite/hybrid candidates
This position reports directly to our Vice President of Digital and IT
Some travel may be required – up to 10%

At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $161,200 - $225,800 plus bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days. For more details regarding Tarsus benefits, please visit: https://alliantbenefits.cld.bz/25tarsusbenesnap.

#LI-Hybrid

#LI-Remote

Tarsus Pharmaceuticals, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

Average salary estimate

$193500 / YEARLY (est.)

min

max

$161200K

$225800K

If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.

What You Should Know About Associate Director, Enterprise Applications (R&D Systems), Tarsus Pharmaceuticals

Are you ready to take on a pivotal role as the Associate Director, Enterprise Applications – R&D Systems at Tarsus Pharmaceuticals? In this exciting position based in sunny Irvine, California, you will be the go-to technology expert for Veeva's clinical and regulatory platforms. You’ll have the chance to roll up your sleeves as you lead the implementation and support of these critical systems. By collaborating with various business functions, including Quality and external vendors, you will ensure that computerized system validations are top-notch. Your day-to-day will involve gathering requirements, assessing risks, and enhancing the efficiency of diverse business capabilities within the biopharmaceutical industry. Not only will you own the IT roadmap for Clinical and Regulatory teams, but you'll also actively contribute to solution designs and user acceptance testing. By working closely with both internal teams and quality stakeholders, you will oversee the integration of Veeva's systems into our operations. A successful candidate will possess at least 12 years of IT experience, including a rich background in system architecture in the life sciences sector. If you are passionate about innovation, thrive in a hybrid work environment, and are excited to contribute to a culture that proudly promotes work-life balance, then Tarsus is the place for you. Attractive compensation, stellar benefits, and a collaborative workplace environment await you!

Frequently Asked Questions (FAQs) for Associate Director, Enterprise Applications (R&D Systems) Role at Tarsus Pharmaceuticals

What are the primary responsibilities of the Associate Director, Enterprise Applications – R&D Systems at Tarsus Pharmaceuticals?

As the Associate Director, Enterprise Applications – R&D Systems at Tarsus Pharmaceuticals, your primary responsibilities include leading the implementation and support of Veeva's clinical and regulatory platforms, acting as a subject matter expert, and collaborating with business functions to improve system efficiency. You'll also conduct requirement gathering, risk assessments, and work on ensuring proper validation processes are in place.