Karen M. Email & Phone Number

Alameda, California, US

Stamford, CT, US

• In addition to the responsibilities established as an Associate Director stated below, in this Senior Director role I was responsible for establishing a "Master Service Agreement Center of Excellence" requiring that I.
• Appointed as the point of contact to create, rollout and establish an onboarding process for new hires within the Business Operations team
• Responsible for creating a playbook for negotiating IT license and SaaS contracts, including language that addresses development, implementation, security and testing
• Responsible for updating the department's various contract templates and working with both inside and outside counsel to ensure that we optimize language, bringing it into alignment with current language for the.
• Proposed and established a process by which scientists would discuss their projects in layman's terms with the Business Operations team, enabling those without a science background to have a better understanding of the.

Stamford, CT, US

• Support strategic and operational aspects associated with the various contracting and procurement needs across the teams at Loxo@Lilly including toxicology, DM/PK, pharmacology, IT, regulatory and discovery teams
• Draft, review, redline and negotiate confidentiality, material transfer, SaaS, software license, consulting and master agreements; on point for privacy language and HCP contracts (ad board, consulting, speaker.
• Collaborate with the relevant functional groups, legal, and finance teams to draft, negotiate and manage contracts
• Manage and advise two (2) other contracts experts, supporting their professional development

Alameda, California, US

• Draft, review, and negotiate nondisclosure and clinical study agreements for six (6) clinical studies spanning sites in the U.S., Europe, Asia, Latin America and Canada
• Lead weekly clinical study agreement discussions to provide solutions to challenging negotiations/provisions and updating the clinical study agreement playbook accordingly
• Identify, define and communicate risk to appropriate internal decision-makers for discussion and resolution
• Interact with various internal stakeholders effectively to address legal questions and risk management
• Improved CRO vendor management by collaborating with Exelixis’ Research & Development Supply Organization Department, providing transparency and resolution to chronic pain points such as consistency in support across.
• Draft templates and create fallback language for clinical contracts

Alameda, California, US

• Under the direction of in-house counsel, draft, review, and negotiate nondisclosure, vendor service, consulting, and (U.S. and ex-U.S.) clinical study agreements
• Successful in providing legal contract support for the company's largest clinical trial to date (~700 global sites) which directly assisted in effective cross-functional team collaboration and completing forecasted.
• Under the supervision of in-house counsel, advise and troubleshoot on existing agreements
• Identify, define and communicate risk to appropriate internal decision-makers for discussion and resolution
• Maintain and track status for agreements
• Handle miscellaneous legal tasks, as needed, under the direction of in-house counsel

Redwood City, California, US

• Draft, review, negotiate, and manage commercial, research and development, clinical (US and Europe), IT, human resources, marketing, with various purchasing, SaaS, service, privacy, and consulting contracts related to.
• Cross-functional project management of teams comprised of various departments/ business stakeholders and outside counsel, both US and Europe-based.
• Assist with the implementation, development, rollout and management of the CMS (Apttus).
• Establish process for providing legal support to the US and Europe clinical teams in the review, drafting and negotiation of clinical trial agreements and informed consent forms; drafting and implementing the necessary.
• Update and develop in-house contract templates (nondisclosure, master service, consulting, clinical).
• Create company-wide contracts management policy.

• Develop, negotiate, track and execute a wide variety of standard agreements including confidentiality agreements, consulting agreements, material transfer agreements, software as a service agreements, license.
• Prepare and negotiate CRO agreements, clinical trial agreements (U.S. and ROW), informed consent forms, and letters of intent for the company’s multiple clinical trial studies; coordinate negotiations with CROs for ROW.
• Partner with finance, compliance, regulatory, clinical science, pharmacovigilance, manufacturing and other departments as appropriate to craft and negotiate contracts.
• Oversee the maintenance of the contract files and database.

• Review, draft and negotiate service, consulting, statements of work, investigator sponsored trials, master quality, SaaS, license, and agency agreements.
• Provide support to the Commercial, Global Strategic Sourcing, Technical Operations, Quality Assurance, Clinical Operations, Medical and Scientific Affairs, Clinical Science, Drug Safety, and Research departments.
• Liaise and partner with Compliance, Global Strategic Sourcing, and Amgen’s International Law Group with regards to contract negotiations.
• Training internal clients and new attorneys on contract processes.
• Proactive in establishing communications with colleague counterparts at Amgen to troubleshoot issues arising during the acquisition transition process.
• Participation in the Medical Review Committee and Clinical Trial Review Committee.

Foster City, CA, US

• Negotiate and create new contract templates specific to department needs in the areas ofCommercial, Learning and Development, Medical Affairs (service, consulting, software license and maintenance, software as a.
• Point person to create, implement, and roll out contracts and processes for Medical Affairs’ Research Scholars Program.
• Liaise and coordinate with multiple departments across functions (Finance, Business Conduct, Risk Management) to identify and resolve potential issues (contracts and projects).
• Provide guidance to attorneys in other departments as appropriate.
• Provide customer support to internal clients, diffusing and mitigating tense situations whilst maintaining a solution oriented approach.
• Proactive in reviewing processes with an eye to coordinating and implementing process improvement to the benefit of multiple teams.

• Responsible for generating, negotiating and finalizing contracts, from inception to conclusion, including but not limited to clinical study agreements, software agreements, service agreements (research, technical.
• Identify, anticipate, prioritize and respond to client needs in a timely, thorough, accurate and efficient manner, coordinating with other departments and outside entities as appropriate.
• Participation in the continuous evaluation of processes and procedures to increase overall process efficiency.
• Active in collaborating with colleagues to successfully negotiate and finalize contracts.
• Proactive in taking the lead in coordinating and implementing resolutions involving various departments.
• Proactive in establishing communications with colleague counterparts at acquiring company to troubleshoot issues arising during the acquisition transition process.

Davis, California, US

• Negotiate contracts and business collaborations with respect to exchange of materials, research, information, and data between UC and outside institutions in agriculture, academia and pharmaceuticals; contributing to.
• Responsible for establishing contracts resulting in the award of research grant monies and outside funding to UC Davis totaling an estimated $2.6 million for the fiscal year 2003.

Emeryville, California, US

• Served as Interim Associate Director, R&D Administration, during the position’s vacancy for seven (7) months. Received management training through Chiron Organizational Learning for Managers; supervised two.
• Implemented the tracking of Consulting Agreement obligations into the AMS Database/Livelink client-server resulting in increased efficiency of consultant payments, better maintenance of consultant contracts, the.
• Managed payment history (invoices and contract obligations) and multi-million dollar budget for the pre-clinical R&D Departments; worked with A/P, A/R, and project teams regarding payments, collections and accruals..
• Used SAP database to create and implement new accrual processes which resulted in increased accuracy and effectiveness of budget projections/forecasting for the pre-clinical R&D departments; implemented budgeting.
• Acted as Vaccines Dept. Public Disclosure Review Coordinator: reviewed and edited public disclosures. Founding member of Chiron’s Science Made Simple Committee, which provided educational science seminars; reviewed and.

Leverkusen, North Rhine-Westphalia, DE

Davis, California, US