The program is designed to provide comprehensive training and experience in a broad range of medical affairs activities, with a focus on oncology therapeutic areas with high unmet needs such as lung cancer and gastrointestinal cancers. The goal of the program is to prepare the fellow to become a successful professional in the biotech/pharmaceutical industry through hands-on training and mentorship in Medical Affairs and clinical practice.
The fellow will collaborate with clinical oncology preceptors at UC San Diego Moores Cancer Center and Medical Affairs preceptors at Mirati Therapeutics. At Mirati Therapeutics, the fellow will have the opportunity to explore and understand all phases of research design and methodology and the broad remit and responsibilities of the Medical Affairs organization. The fellow will gain experience in various areas of Medical Affairs including Medical Information and Communication, Medical Strategy, field-based scientific exchanges (Medical Science Liaisons) and other areas of industry. The fellow will also evaluate medical literature to create accurate, fair-balanced medical content for scientific engagement. In addition, the fellow may have an opportunity to gain experience in various drug launch preparation and execution of key deliverables as well as participate in an elective rotation in functions outside of Medical Affairs.
Within the UC San Diego Moores Cancer Center are outpatient clinics, an infusion center, and investigational drug pharmacy. Fellows may appropriately provide the preceptors with assistance in filling the needs of their practices throughout the course of the scheduled time, but the emphasis of the experience is on learning; fellows will not be relied upon to maintain services. The experience provides the fellow with opportunities for enhanced knowledge, problem-solving, continued growth and independence. Responsibilities will include but are not limited to direct patient care, medication consultations, participation in multidisciplinary rounds, intravenous preparation, prescription processing, patient consultations, and administrative activities where appropriate.
This program will be tailored based to the education and training background of the fellow. Fellows will have the opportunity to pursue didactic coursework toward a Master’s degree in drug development and product management at UC San Diego.
Fellowship Program Objectives:
1. Medical Information and Communications
Develop, update and review Medical Information content for healthcare providers and patients/caregivers such as medical response documents and scientific content.
Work in conjunction within Medical Affairs on development of scientific and educational materials; ensure that materials available for external dissemination are compliant and fair-balanced
Work with Medical Capabilities team on process improvement initiatives, implement new technologies to support Medical Information services, ensure inspection readiness, and help with Medical Resource Library platform
Staff the Medical Information booth at national scientific meetings
Provide support in medical reviews of promotional and non-promotional materials at Medical, Legal, and Regulatory Committee (MLR) meetings
Serve as “on demand” Medical representative for responses to medical and scientific information requests from healthcare professionals, patients, general public and internal stakeholders, ensuring prompt, accurate, quality-assured responses.
2. Field Based Medical
Develop skills to become a field-based oncology professional with therapeutic area expertise responsible for providing clinical and scientific support on assets in development
Learn the regulatory aspects of field-based medical work, focused on compliant interactions with healthcare professionals
Participate in field rides with personnel in the regional medical affairs team and engage in scientific discussions with oncology thought leaders, clinical trial investigators, community practitioners, payers/access stakeholders, and/or other healthcare professionals
Respond to external inquiries and deliver appropriate clinical and scientific information
Support medical conference planning and activities such as medical booth coverage, pre- and post-congress debriefs and scientific coverage
Understand the role of field-based health outcomes through experiences such as engaging in health economic discussions with targeted payer customers and access stakeholders, pharmacy benefit management companies (PBMs), specialty pharmacies, and/or other healthcare professionals
Gain a broad understanding of the community oncology segment in the US, key stakeholders in community oncology and healthcare landscape (i.e. reimbursement/access, diagnostic testing, care delivery)
3. Medical Strategy
Participate in the development and implementation of medical plans and ensure alignment of key medical activities to the medical strategy
Collaborate cross-functionally to ensure strategic, timely and appropriate scientific communication and external engagement activities around major congresses and medical meetings
Contribute to the development of high quality medical content deliverables, including slide decks, FAQs, and background documents for training
Participate in the planning and execution of an advisory board meeting, content development and discussion topics, and develop a summary of key insights from the meeting
4. Clinical Oncology
Demonstrate adequate data collection and interpretive skills such as obtaining patient information, prioritizing and researching patient problems, presenting patient, and monitoring patient data
Develop patient-specific drug therapy by applying PK principles and evidence-based guidelines, as appropriate, and evaluating possible drug interactions, adverse events, medication errors and response to therapy.
Identify, evaluate, and communicate the appropriateness of specific therapeutic agents, dosing regimens, dosage forms, routes of administration, and delivery systems.
Demonstrate effective verbal and written patient education or communication to diverse patient population.
Participate in rigorous institutional review of oncology-related study protocols for scientific merit, regulatory requirements and subject safety
5. Didactic Coursework
Develop an individualized Strategic and Tactical Career Plan (STCP)
Participate in case-based, small group teaching modalities
Compare and contrast clinical trials including, Phase 0, 1,2,3, drug-drug interaction, drug-food interaction, and bioequivalence trials.
Identify differences of outcomes and endpoints between oncology and non-oncology clinical trials.
Incorporate study design methods for consideration in the design of clinical protocols to assess pharmacokinetics, safety, tolerability, and efficacy.
Applicants must meet the following minimum qualifications: Pharm.D. or Pharm.D./Ph.D. degree or equivalent (awarded or in process) and be licensed or eligible for California licensure as a pharmacist. Applicants must be a U.S. citizen or a permanent resident at the time of application.
For any additional program information or questions, please email:
Joseph Ma, PharmD, FCP
Professor, Division of Clinical Pharmacy
Skaggs School of Pharmacy and Pharmaceutical Sciences University of California, San Diego