Senior Director Operations, Medical Affairs

POSITION SUMMARY:

Reporting to the Senior VP of Medical Affairs, this position will be responsible for the strategic direction of Medical Affairs (MA) Operations and the oversight of activities essential to the timely execution and tracking of Medical Affairs projects, particularly as it pertains to operationalizing the Investigator Sponsored Trials (IST) Program and the US-based Expanded Access Program (EAP), the Medical Affairs training and development capabilities and medical education grants activities at Rigel. He or she will ensure process excellence by collaborating with leaders within Medical Affairs to enhance existing processes and/or develop new processes, tools, and resources to support both Rigel internal stakeholders and external stakeholders This position will also work cross-functionally with other leaders and functions (including all Medical Affairs functions, Compliance, IT, Finance, Clinical Development and Legal) The ability to work with and influence stakeholders across all levels will be essential.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• The successful candidate will oversee a variety of critical functions within the Medical Affairs department, ensuring efficient operations, compliance, and strategic alignment.
• He/she will be responsible for managing the annual budget, ensuring optimal allocation of resources to support strategic initiatives.
• Collaborate with cross-functional teams to monitor budget performance, identify cost-saving opportunities, and ensure financial transparency.
• Establish and maintain a library of Medical Affairs SOPs to ensure consistency, compliance, and best practices across all functions.
• Continuously review and update SOPs to align with evolving industry regulations and organizational needs.
• Work in collaboration with Medical Affairs colleagues to develop medical education and external research/IST objectives and annual plans for Rigel therapeutic areas.
• Lead internal review committee meetings for the endorsement and approval of IME programs and management of external research/IST studies.
• Manage all operational aspects of the IST, EAP, collaboration research programs at Rigel and provide input on IST strategies for Medical Affairs molecule plans.
• Enhance the framework for IST operational excellence to ensure current and future excellence is achieved and maintained; enable development of an agile, innovative, and scalable IST Program.
• Developing financial reports, aggregate spending reports and budget forecasting for the IST Program.
• Develop and update reports and track metrics on the external research program (e.g. IST dashboard, department reports, IST and EAP tracker).
• Develop training plans and resources for both internal and external stakeholders as well as ensure timely training of new associates on external research process.
• Identify and implement operational efficiencies and best practices amongst the IST portfolios.
• Facilitate the development of strategy, medical education objectives and medical education plans, including the development of Requests for Applications, to address educational needs.
• Define and document the process for identifying the educational needs and practice gaps based on independent, external data and leads the grant managers in the development of mutually aligned medical education objectives.
• Maintain oversight of the educational grant budget ensure accurate budget forecasts are developed each quarter.
• Provide recommendations for improving the impact of medical education investments and develop a plan for implementation and evaluation of impact.
• Oversee the operational management of the IME Grant program to ensure compliance with Rigel criteria, policies, and procedures.
• Direct the development and publication of performance metrics for the IME grant program.
• Oversee the communication of results of the IME grant program to stake holders within the organization.
• Identify process improvements related to the processing of grant requests and work with team to implement changes.
• Assume a Leadership role within relevant external medical education and/or professional communities to represent Rigel. Build strong relationships with both internal and external stakeholders (external medical education/and or professional communities, IST and ensure continuous and consistent communication with key stakeholders.
• Create, gain approval, and implement educational and training programs while interfacing with departmental managers.
• Work with Medical Affairs leadership to determine baseline knowledge of each staff member to determine educational gaps and design customized training programs.
• Coordinate the creation of new scientific materials in relation to new scientific developments with each therapeutic area leadership team for MSL field use.
• Conduct Assessment of Medical Affairs capabilities, processes, and systems to identify gaps and opportunities for improvement.

KNOWLEDGE AND SKILL REQUIREMENTS:

• Strong understanding and demonstrated success in managing Medical Affairs Operations.
• Ability to analyze a business problem, synthesize complex information, develop an appropriate strategy, and implement effective tactics.
• Must be a team player with strong self-awareness and excellent interpersonal skills.
• Must be results oriented, attention to detail, accurate, prompt, and able to meet established deadlines, including the ability to drive multiple projects simultaneously and deliver results.
• Proven leadership and cross-collaboration skills
• Demonstrated ability to influence others and to successfully lead in a cross-functional environment.
• Occasional travel (up to 10%) for conferences and meetings
• Bachelor’s degree required, preferably in a health-related field. Master’s degree or higher preferred. Oncology experience preferred.
• Targeting 10-12 years of progressively responsible operational or program management experience in the biotech or pharmaceutical industry including Medical Affairs.
• Experience managing vendors.
• Demonstrated expertise in the management of external research programs.
• Experience working with spreadsheets (e.g., Excel, Smartsheets, pivot tables).
• Demonstrated understanding of the legal and regulatory guidelines (e.g., PhRMA, ACCME, Sunshine Act, etc.)
• Occasional travel (up to 10%) for conferences and meeting
• Rigel requires all employees to be vaccinated against COVID-19 (subject to any legally required exemptions)

WORKING CONDITIONS:

• PHYSICAL DEMANDS: While performing the duties of this job, the employee is required to stand, walk; sit; talk. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and the ability to adjust focus.
• WORK ENVIRONMENT: The noise level in the work environment is usually moderate.

Rigel Pharmaceuticals, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any othercharacteristic protected by the law.