Sandra Park Email & Phone Number

United States

Austin, Texas, Us

 Building, developing, and leading a team of attorneys, including people managers, advising in the cutting-edge gene therapy field, counseling on nearly aspect of medical, commercial, and privacy activity, culminating in three successful launches in cell therapy and doubling of company revenue in less than two years.  Providing regular legal analyses and pragmatic enterprise-level business options to C-suite level executives, including directly to the CEO of Kite and SVPs of Commercial, Market Access, Medical Affairs, Public Relations, and Regulatory. Advising CEO on complex issues specific to CAR T-cell therapy patient support, patient journey innovations, and marketplace referral dynamics.  Interacting with FDA-CBER, HHS-OIG, HHS-CMS, other federal and state government entities, and payers to maximize patient access to CAR-T therapy with Gilead Government Affairs, including addressing IRA impact and a successful OIG Advisory Opinion. Role-modeling the player/coach aspect of management by serving as the legal subject matter expert for Global Market Access, Investor Relations, and Global Public Affairs during major organizational shifts (e.g., post-acquisition reorganization, C-suite level leadership realignment). Advised VPs and SVPs of those functions on pricing strategies, distribution networks, patient support programs, press releases and corporate branding, and investor relations presentations. Reporting directly to the Kite General Counsel, strategizing and executing on shifting Kite Legal culture and engagement, and ensuring smooth change management, and managing my departmental budget. Working directly with Kite Compliance VP to roll-out the first compliance manual, significant company-wide policies and SOPs, and co-leading training.

• Overseeing legal services provided by the practice group and helping ensure consistency of legal advice on healthcare law issues, including healthcare fraud and abuse, labeling, advertising and pharmacovigilance, product liability, reimbursement, antitrust, privacy, and other matters relevant to the marketing and sale of products and their ongoing support through US Medical Affairs• Performance management and professional development of attorneys and staff in the practice group, and contributing to same for attorneys and staff across the Healthcare Law Team• Serving as a standing member of the Healthcare Law Leadership Team and contributing to Legal department projects and initiatives• Cultivating a culture that reflects a strong commitment to employee engagement, diversity and inclusion• Fostering strong relationships with senior leaders in Commercial and Medical, advising and/or delegating authority to advise senior leaders and to proactively identify and manage legal issues, creating efficient and effective processes for working with clients, and acting as a standing or ad hoc member of business or leadership teams• Participating in, leading, and/or presenting to various Company committees or other advisory, project or work teams and provides legal expertise and guidance

Among other responsibilities, I was actively involved the following:* Lead attorney for all medical and Commercial matters related to an immunotherapy launch and multiple other oncology line extension launches* Lead attorney for a number of different cross-functional teams, such as teams that: ** Review and approve promotional materials ** Negotiated BLA and sBLA labeling with FDA ** Managed global healthcare entities and emerging global issues ** Provided strategy and oversight in the social media/digital space

* Drafted and published Citizen Petition Responses on various pharmaceutical issues (e.g., safety, public health, etc.)* Provided regulatory counsel for eight-factor analyses for DEA scheduling* Provided regulatory analyses for various industry guidances

Philadelphia, Pa, Us

I have:* Furnished legal analysis to a large pharmaceutical client regarding appropriate pre-approval activities for a potential new drug, including appropriate disease state awareness communications* Seconded at a large global pharmaceutical manufacturer client and served as in-house counsel (one year) whose responsibilities included:* Providing analysis and legal advice to sales and marketing operations during the roll-out of new electronic compliance initiatives* Providing analysis and legal advice prior to and during the implementation of programs and policies to adhere to the PhRMA Code and PhRMA DTC obligations* Providing analysis and legal advice for Internal Audit in numerous healthcare compliance audits ranging from sales representative T&E to managed care processes* Drafting vendor compliance contracts and overseeing the roll-out of same* Drafting and overseeing the programmatic implementation of corporate compliance policies and SOPs* Providing analysis and legal counsel during Government CIA negotiations* Assisting in responses to government and internal investigations related to potential False Claims Act and Anti-Kickback Law violations by: • Interviewing witnesses and drafting interview summaries for presentation to client stakeholders • Analyzing documentary evidence, including promotional materials for potential off-label promotion and determining risks of same* Provided legal advice and analysis to various stakeholders (including business, audit, finance, etc.) of a large global pharmaceutical manufacturer regarding implementation of their CIA

Worldwide, Gb

New York, Ny, Us

Woonsocket, Ri, Us

Bachelor Of Science - Bs, Pharmacy

Jd

Education record

H.S. Diploma