Sr. Director, Global Regulatory Affairs, Oncology

Job Description

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North, South and Central America, Europe, Africa, Asia and Australia. Gilead makes it a priority to increase access to its medicines for people who can benefit from them, regardless of where they live or their economic status.

POSITION OVERVIEW:

As a Sr. Director, Early Oncology Global Regulatory Affairs, you will develop and execute Oncology regulatory strategies in alignment with the global regulatory strategies in collaboration with Franchise Lead and cross functional stakeholders in compliance with the appropriate regulations. You will act as the Global or Regional Regulatory Lead on complex or multiple products, compounds, indications or projects in the assigned therapeutic area. You will typically be assigned a portfolio of products or projects in early Oncology to lead, manage and oversee simultaneously. You will define the regulatory strategy, plans and objectives for assigned products or projects. Though the role is primarily focused on early oncology assets, you may act as the Global Regulatory Lead for early-stage, late-stage, or other programs depending on business needs. You will lead Regulatory Submissions Teams or other Regulatory Project Teams and represent Global TA Regulatory on cross-functional core and sub-teams including Project Strategy Teams. You will oversee preparation and maintenance of regulatory submissions, regulatory labeling and packaging for assigned products or projects; guiding and advising other colleagues in the thorough and compliant completion of these activities. You will provide operational and technical regulatory assistance through all stages of clinical development through global registration, as needed. You will play a leadership role in ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities. You will also help develop the TA's Regulatory leadership pipeline through coaching and mentoring other Regulatory colleagues and regional leads.

Location: Parsippany, NJ

FUNCTION: Global Therapeutic Area (TA) Regulatory Liaisons

RESPONSIBILITIES:

• Accountable for the successful oversight and completion of a broad spectrum of regulatory activities and deliverables for products, compounds, indications and/or other projects in the oncology therapeutic area.

• As needed, represents Gilead in negotiations with regulatory authorities. Oversees contacts for local regulatory authorities.

• Works on extremely complex problems and provides solutions that have significant impact.

• Makes significant contributions to the ongoing development and refinement of regulatory strategies, processes, standards, practices, efficiencies and capabilities.

• Represents Regulatory Affairs and may serve as Regional Lead or Global Regulatory Lead on cross-functional/cross-regional Regulatory Submission Teams and Project Strategy Teams. Provides strategic advice and guidance to Regulatory Affairs and cross-functional leaders and teams.

• Advises other functions on short- and long-range regulatory strategies, plans, resources and tactics as the global regulatory representative in cross functional meetings such as the program strategy team and global development team.

• May participate on other Sub-teams (e.g., Study Management, Clinical, Nonclinical, Biomarkers) or assign such to other colleagues and oversee and guide their sub-team participation.

• Defines, oversees, and communicates the regulatory strategy for assigned products or projects.

• Proactively identifies regulatory or related risks/issues and develops mitigation and/or contingency plan.

• Oversees and guides the preparation, compilation, and timely filing of regulatory submissions, which require cross-functional interactions for commercial or investigational product(s). Examples include meeting requests, briefing packages, original Investigational New Drug (IND), IND amendment, original New Drug Application (NDA), supplemental NDAs, and routine submissions (e.g., Development Safety Update Reports / DSURs, Investigator Brochure/ IB updates, etc.).

• Oversees the authoring and approval of regulatory documents, including meeting requests, Module 1 documents for original IND/NDA, etc.

• May oversees and guides labeling, packaging and associated information updates and maintenance in accordance with the product license for assigned products and markets.

• Critically reviews documents for submission to regulatory authorities.

• May have one or more direct reports.

• Provides matrix management and leadership to project teams.

• Provides accurate and thorough input and recommendations into resource plans required to complete team deliverables. Tracks resources to ensure compliance with agreed resource allocation, including budgets.

• Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.

REQUIREMENTS:

We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

U.S. Education & Experience

• PharmD/PhD with 10+ years’ relevant experience.

• MA/MS/MBA with 12+ years’ relevant experience.

• BA/BS with 14+ years’ relevant experience.

• Extensive regulatory, quality, compliance or related experience in the biopharma industry.

• Extensive experience and significant successes setting and directing the regulatory or related strategy to successful conclusion for multiple products.

• Extensive experience participating in cross-functional projects and teams with responsibilities related to clinical trials or other drug development activities.

• Experience and proven effectiveness working and negotiating with regulatory authorities.

• Significant experience participating in cross-functional projects and teams with responsibilities related to clinical trials or other drug development activities.

• Line management (direct reports) experience is strongly preferred.

• Proven track record of effective people leadership and management, as evidenced through past effectiveness with employee engagement, development and retention either with direct reports or through matrix leadership responsibilities.

• Proven track record of successfully managing large scale, complex, time-sensitive projects.

• Experience working with one or more Gilead therapeutic areas and varying stages of drug development is strongly preferred.

Knowledge & Other Requirements

• Expert knowledge of the drug development process, global and regional regulatory requirements for medicinal products.

• Expert knowledge of all key functions involved in the various stages of drug development from early research through post-marketing.

• Demonstrates advanced regulatory and business knowledge and advanced analytical abilities, as evidenced by strengths in assessing complex, multidisciplinary data, understanding and effectively advising on its regulatory implications.

• In-depth knowledge of relevant health authorities (HAs), including people, system, processes and requirements, as evidenced by past effectiveness and successes in conducting HA interactions.

• Able to represent Gilead to regulatory authorities when managing standard and non-standard negotiations.

• Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives.

• Strong interpersonal skills and understanding of team dynamics.

• Strong communication and organizational skills. Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives and steering committees.

• Strong negotiation and conflict resolution skills.

• Strong coaching capabilities to mentor/develop staff.

• When needed, ability to travel.