Executive Director, Digital Regulatory and Safety

Job Description

At our company we aspire to be the premier research-intensive biopharmaceutical company. Were at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We use the power of leading-edge science to save and improve lives around the world.

Reporting to the Associate Vice President Clinical and Development Digital Solutions (CDDS IT) the Executive Director Digital Regulatory and Safety will lead our efforts in transforming regulatory submissions and pharmacovigilance through modern platforms and responsible generative AI.

Primary Responsibilities:

• Develop and promote a multiyear product strategy for Digital Regulatory & Safety aligning with IT and Research and Development (R&D) priorities including prioritized roadmaps and investment cases to deliver enterprise value focusing on innovation risk regulatory compliance and scalability.

• Act as a senior technology business partner to various stakeholders translating strategic needs into product investments.

• Define and drive adoption of target-state architecture and reusable capability layers across Regulatory and Pharmacovigilance with a focus on integrated platforms and thoughtful end to end capabilities

• Lead the responsible adoption of generative AI technologies for regulatory authoring and translations across R&D partnering with enterprise technology teams Legal and Compliance

• Develop and support the practice of product management building the mindset and practice of end-to-end accountability of product lifecycle resolving uncertainty early through product discovery and agile practices and identification of reusable patterns that enable scale and efficiency in product delivery.

• Build and scale a high-performing product organization manage a group of40-60technology professionals promoting career development and continuous upskilling of talent to build incredible teams and the ecosystem to empower them.

• Develop an external presence and strong internal networks to recruit highly skilled and diverse talent stay current with industry trends and establish effective vendor partnerships

Education:

• Bachelors degree in IT computer science life sciences or related discipline; advanced degree preferred.

Required Experience and Skills:

• 12 years of progressive technology/product leadership in pharmaceutical biotech or regulated life sciences.

• 5 years of experience in technology enablement for regulatory or safety with management responsibilities.

• Proven track record in setting and delivering product strategy in regulatory affairs and pharmacovigilance domains with an ability to execute consistently rapidly and effectively.

• undefined

• Outstanding interpersonal and communication skills; adept at working with colleagues from diverse disciplines and at all levels of the company articulating complex technical topics at the right level of detail for specific audiences.

• Proven experience in team building mentoring and leadership with a demonstrated ability to inspire others to follow a common vision.

• Excellent stakeholder management communication and influencing skills at senior levels across global organizations.

• Experience managing strategic vendor relationships and third-party platform implementations.

Preferred Experience and Skills:

• Experience with Veeva (Vault Regulatory Vault Docs) or equivalent regulatory authoring/publishing platforms.

• Demonstrated experience delivering regulatory affairs and pharmacovigilance technology solutions (authoring/publishing PV case management/reporting labeling/registrations translations).

• Hands-on experience with LLM-based enterprise applications for authoring or translation.

• Experience with enterprise AI/ML programs including generative AI/LLM applications and model governance in regulated contexts.

Required Skills:

Preferred Skills:

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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 Monday - 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 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 salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

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