Senior Director, Head of Medical Affairs
Exciting opportunity for a highly motivated, experienced physician with the appropriate background to build and lead the execution of the Medical Affairs strategy to support the planned launch of our novel, late-stage, cell-based immunotherapy product AGS-003, and other ongoing development activities. This hands-on leadership role reports directly to the company’s Chief Medical Officer, and will be responsible for building/maintaining strong collaborations with top KOLs and key physicians globally, effectively supporting the clinical organization, establishing productive, compliant partnerships with the Commercial organization, and building the Company’s Medical Information portal. The focus for this role is the staged building of a Medical Affairs function that ensures that the Global Oncology community is well informed about the clinical and scientific basis for the therapeutic use of our novel immunotherapy platform, and will also monitor disease/treatment trends, and the competitive landscape to provide strategic input to the organization. This position will help to set all global Medical Affairs strategies and be accountable for the management of all global Medical Affairs initiatives spanning in-house, outsourced and field-based activities in support of all therapeutic areas; a strong emphasis on high quality standards, compliance with regulatory requirements, and fiduciary responsible execution within project budgets is essential.
- Drive the development and execution of the Medical Affairs strategic global plans in alignment with Clinical, Regulatory, Commercial and Corporate Communications groups including:
- Disease/Mechanism of Action Education Plan
- KOL/Advisory Board Management Plan
- Medical Communication, Publication, and Congress Plan
- Medical Information and Call Center Plan
- Investigator-Sponsored Trial (IST)/ Phase 4 Development Plan
- Medical Educational/Medical Society Grant Plan
- Expanded Access/Compassionate Use Plan
- Nurse Specialists Plan
- Field Medical Liaison Plan
- Ensure alignment of global medical affairs strategies with the overall Medical and Commercial goals and objectives of the organization.
- Identify medical information gaps/open research questions and develop strategies to address and optimize product profiles.
- Provide medical input for scientific and promotional documents, and support of business development activities.
- Lead the development of the IST review and approval process, prioritize areas of interest, and monitor the execution of ISTs and Company-Sponsored Phase 4 studies.
- Work with Medical Development on secondary analyses of primary data and lead the development and execution of clinical registry studies and observational research to address information gaps as appropriate.
- Drive major international scientific congress planning; strategically target relevant meetings and assure data for Argos products appropriately positioned for presentation in alignment with our corporate strategic objectives.
- Work cross functionally to collaboratively identify and qualify centers of excellence in alignment with the MSL, Nurse Specialist, Medical Development and Commercial groups and the planned launch plan timeline.
- Serve as a member of the Communication Review Committee (CRC) and contribute to the review of key publications (abstracts, manuscripts, posters, presentations, etc.) and promotional pieces to assure they are consistent with the scientific data, product labeling and global disease strategy.
- Drive the development and delivery of disease- and product-specific educational slide decks and/tools and training materials in collaboration with key internal and external stakeholders.
- Coordinate and support the execution of a global plan for Expanded Access/ Compassionate Use patient access programs with internal stakeholders and external vendors.
- Serve as key external spokesperson with global KOLs, payors, and professional societies.
- Contribute to the development and maintenance of a competitive intelligence database in partnership with the MSL, Nurse Specialist and Medical teams.
- Board Certified MD, preferably in Oncology
- At least 7 years of industry experience in Medical Affairs with an intimate knowledge of the role of Medical Affairs in the Pharma industry, good understanding of the KOL landscape, and launch experience preferred.
- Passionate, strategic thinker who is highly driven to be the best, and also contribute both individually and as a leader in a growing, cutting-edge biotech.
- Proven ability to reliably deliver, independent and self-motivated with a strong collaborative work ethic.
- Strong interpersonal skills and demonstrated success in achieving results through cross-functional collaborations.
- Proven leadership and management skills; commitment to mentoring and talent development
- Good understanding of GCP, clinical trial designs, regulatory guidance, and the drivers of successful product marketing.
- Proven attention to detail and ability to understand, interpret and explain complex clinical data and disease states.
- Experience with designing and executing Phase 4 studies and overseeing ISTs.
- Good business instincts and high ethical standards.
- Highly self-motivated problem solver with strong leadership and collaboration skills, a can-do attitude with a sense of urgency, who drives collaboratively for results, taking initiative and personal accountability, and effectively managing complexity and resourcefully dealing with ambiguity.
- Clear written and verbal communication skills, including presentations to large groups, and sound interpersonal skills including conflict management.
- Demonstrated ability to work cross-functionally and value colleague contributions and teamwork.
- Track record of “partnering” successfully with the Commercial organization and effectively building strong relationships with external partners and delivering high quality results.
- Ability/willingness to travel as required (approx. 50%).