Establishes and conducts Medical Affairs Operations ensuring alignment and inclusion of activities, to support the commercial and scientific objectives of the company to meet the current needs and plan for future growth, development and services. Ensure Medical Strategies and tactics are developed in alignment with other key functional areas, including CMR, sales, marketing, market access and government affairs. Develop and maintain good fiscal planning, IT solutions appropriate for Medical Affairs in-house and field activities reporting. Partner with Clinical, Legal and Finance to ensure operational excellence.
Specific responsibilities will include:
Supports the VP of Medical Affairs in administrative activities including: budget planning utilization and project prioritization.
Facilitates initiation and approval of Medical Affairs contracts and provides oversight and resolution to issues regarding routing/tracking of process-related documents through appropriate invoice approval system and Accounts Payable.
Authors, co-authors, trains and maintains written procedures specific to Medical Affairs operations and relevant policies, business processes, etc.
Route and track progress of Medical Affairs Policies, Work Instructions and Guidelines in appropriate systems; consolidate and communicate comments to appropriate team members.
In close collaboration with Field Medical Affairs, Medical Communication and Competitive Intelligence, develop and implement a system for employee training on foundational scientific and business knowledge content.
Oversees development, approval and maintenance of Medical Affairs training materials for the Medical Affairs functions.
Develops organizational design plans and recommendations working with MA Leadership team (MALT) based on evolving market dynamics and HCP/influencer needs.
Administers the business processes for IIR from grant approval by Grant Review Committee (GRC) to study closure, including: contract administration; liaising with study site legal and financial contacts: supply chain liaison; milestone payment tracking; and coordination with Medical Communications Manager and MSL’s.
Participates in the development and maintenance of necessary Medical Affairs IT infrastructure and resources as required (e.g. website, portals, databases, user acceptance testing, review of specification documents, IIR management system implementations)
Distributes periodic reports as appropriate related to Medical Affairs Operations, including: monthly financial accruals, drug demand analysis and project status reports to facilitate decision making, areas of focus, process improvement, priorities and issue resolution.
Identifies, analyzes and communicates problems, issues and opportunities. Develops and implements effective solutions to achieve desired outcomes.
Special projects as assigned by the VP of Medical Affairs.
PharmD, PhD, or MD in relevant scientific field required.
10+ years’ progressive experience required.
At least 5-7 years of experience leading either Medical Affairs home-office or field-based teams, preferred.
At least 5 years of experience managing others, preferred.
Research or pharmaceutical industry experience in the field of migraine, preferred.
Knowledge of applicable regulatory, legal and compliance standards.
Demonstrated ability to work cross-functionally.
Excellent verbal and written communication skills.
Travel requirement 50% including overnight stays.
Critical Competencies for Success:
Effective communication skills written, verbal and public speaking.
Relationship building capacity & orientation.
Strong strategic mindset, understanding of market needs and resource allocation.
Familiarity & comfort with Medical Affairs activities such as Medical & KOL strategy and management, medical education, medical operations, clinical Competitive Intelligence, medical congresses, investigator-initiated research and professional society relationship management.
Alder BioPharmaceuticals, Inc., is a clinical-stage biopharmaceutical company that discovers, develops and seeks to commercialize genetically engineered therapeutic antibodies with the potential to meaningfully transform current treatment paradigms.
Alder’s lead pivotal-stage product candidate, eptinezumab, is being evaluated for migraine prevention. Eptinezumab is a monoclonal antibody that in...hibits calcitonin gene-related peptide (CGRP), a protein that is active in mediating the initiation of migraine.
Alder is additionally evaluating ALD1910, a preclinical product candidate also in development as a migraine prevention therapy. ALD1910 is a monoclonal antibody that inhibits pituitary adenylate cyclase-activating polypeptide-38 (PACAP-38), another protein that is active in mediating the initiation of migraine.
Clazakizumab, Alder’s third program, is a monoclonal antibody candidate that inhibits interleukin-6 and is licensed to Vitaeris, Inc.
Alder’s mission is to help alleviate human suffering by generating better and safer antibody therapeutics through novel technologies. The work being done at Alder today will potentially help those who suffer from migraine, autoimmune diseases, and inflammatory diseases.