Director - Patient Safety

Job Description

Associate Director Patient Safety TA Safety Scientist

Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987, that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people.

Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development.

INTRODUCTION:

Gilead’s Patient Safety team is seeking an experienced Associate Director to support the development, filing and marketing of a broad and innovative cancer immunotherapy pipeline, including partnerships with external companies.

Working as part of a diverse team of MDs and non-MDs within Patient Safety, the ideal candidate will offer excellent cross-functional working skills in order to champion the voice of patients in development programs spanning all phases of development, filing for market authorization and support of marketed molecules.

The candidate should be able to implement benefit-risk activities, contributing where possible to design and strategy within cross-functional and cross-company networks. As a member of the safety team, experience of working in small agile teams to address benefit-risk challenges will be important. Putting the patient first and engaging in the friendly and open culture of the team, the ideal candidate will bring a collaborative, agile and positive spirit to advocate for patient safety.

POSITION OVERVIEW:

You will develop and ensure that strategic scientific input relative to safety is incorporated into product development and lifecycle management as well as perform other safety activities for one or more products in the assigned therapeutic area.

You will ensure that signal detection, development of benefit-risk evaluation management plans and risk minimization activities, authoring of aggregate safety reports and safety-related responses to regulatory inquiries are performed in a timely and quality manner. Represent Patient Safety Oncology on cross-functional teams, provide Patient Safety Oncology input into study-related activities and documentation, regulatory submissions, and pharmacovigilance (PV) processes and projects.

Mentorship of less experienced colleagues.

RESPONSIBILITIES:

• Makes contributions to clinical development and/or medical strategies, including Patient Safety Oncology guidance into clinical trial design.

• Authors and/or oversees the preparation of aggregate safety reports and risk management plans (RMPs).

• Conducts signal detection and evaluation activities for assigned products as part of the continuous benefit-risk evaluation throughout the product lifecycle.

• Supports implementation of decisions from the signal evaluation process, including updates to core safety information, Investigator’s Brochure and other key safety documents and deliverables.

• As needed, contributes to Patient Safety Oncology activities and input related to regulatory filings (e.g., Marketing Authorisation Applications [MAAs], New Drug Applications [NDAs], Biologics License Applications [BLAs]), and responses to safety queries from third parties, such as regulatory agencies.

• Performs safety reviews of clinical trial protocols, Investigator’s Brochures, clinical study reports, informed consent forms, and other study related documents.

• Participates on cross-functional teams, including Patient Safety Oncology functional area support in PV audits and inspections.

• May serve as medical monitor for post-authorization safety studies.

• May provide matrix management and leadership to project teams.

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

REQUIREMENTS:

Education & Experience

BA/BS or advanced degree in life sciences or related field with significant relevant experience in the biopharma industry, regulatory agency, clinical research or other related healthcare environment, including significant experience working in drug safety/PV or a related field.

It is essential that you are able to write a clinical study report and protocols

Knowledge & Other Requirements

• Knowledge of worldwide PV regulations and their application to safety science.

• Thorough knowledge of the drug development process, Good Clinical Practices (GCP) and Good Pharmacovigilance (GVP), including all key functions involved in the various stages of drug development from early research through postmarketing.

• Demonstrates advanced scientific / clinical knowledge and analytical skills, as evidenced by strengths in assessing complex data sets and understanding the safety / clinical implications.

• Proven abilities to anticipate problems of varying complexity and lead the resolution of these in a collaborative manner across functions. Demonstrated ability to work effectively in cross-functional teams and projects, as evidenced by past successful cross-functional collaboration.

• Strong interpersonal skills and understanding of team dynamics.

• Strong communication and writing skills, project management skills and proficiencies with Microsoft Office suite, as evidenced through abilities to assume assignments and projects with increasing independence.

• Strong negotiation and conflict resolution skills.

• When needed, ability to travel.

The Gilead Difference

Everyone at Gilead is motivated by our overarching mission to discover and deliver innovative therapies that improve patient care in areas of unmet medical needs. But it’s just what we do that gives us an edge, it’s how we do it. We expect everyone at Gilead to lead by example, guided by our core values:

• Integrity (always doing the right thing)

• Teamwork (collaborating in good faith)

• Excellence (working at a high level of commitment and capability)

• Accountability (taking personal responsibility)

• Inclusion (encouraging diversity)