Head of Medical Affairs
Head of Medical Affairs
The Head of Medical Affairs will be responsible for building a Medical Affairs department in a growing organization, leading medical strategy and execution, launch preparations and all aspects of Aspyrian’s pipeline.
Key Duties and Responsibilities
Organizational Leadership/Launch Preparations
- Build and lead the Medical Affairs organization
- Responsible and accountable for the formulation and the management of the medical affairs budget and timelines
- Work closely with external thought leaders and internal stakeholders to support development of our pipeline.
- Lead the development of medical information plan and infrastructure in conjunction with Pharmacovigilance and other key functions.
- In collaboration with Legal and other functions, review & develop departmental policies, SOPs related to compliance and oversee execution/adherence to process and compliance policies.
- Review and approve external communication documents, including medical, scientific and promotional materials.
- Build and develop internal training program for medical & commercial team members and other stakeholders.
- Implement measurable policies regarding customer and product medical education within the team to assure a high level of customer satisfaction and compliance.
Scientific Communications, Internal and External Collaborations
- Lead global scientific communications strategy and collaborate on execution of abstracts and publications.
- Oversee a field-based medical science liaison (MSL) team that will grow and manage a thought leader network to support successful implementation of medical affairs plans. Support efforts to expand KOL identification and outreach in key therapeutic areas beyond existing/known Centers of Excellence.
- Establish and lead national and regional advisory boards to drive better understanding of key strategic evidence gaps, drive lifecycle strategy, develop disease awareness initiatives and patient engagement programs
- Develop value propositions and lead preparations for formulary/managed access presentations for Aspyrian’s products.
- Remain informed of current developments within pertinent medical and scientific communities through familiarity with current literature, attendance at meetings, conventions, professional associations, etc. and shares the information with appropriate parties.
- Ensure appropriate review and approval of medical and scientific content of Regulatory, Safety, Scientific Affairs, Medical Affairs and Commercial outputs.
Data Generation, HEOR, Compassionate Use & other Clinical Program Leadership
- Lead strategy and execute internal/external collaborations in outcomes, research, cross-sectional analyses and other HEOR initiatives as needed.
- Compliantly communicate and interact with patient interest groups and other relevant stakeholders in support of providing access to Aspyrian’s products through compassionate use and expanded access programs.
- Participate in the global team to evaluate potential proposed research concepts and protocols for investigator-initiated studies (IIT), assessing such IITs for medical/scientific merit, appropriate design and strategic fit with development and product life cycle plans.
- Work closely with commercial/market access team to develop compelling medical evidence to support optimal patient access to our medicines.
- Provide input into global phase 3b/4 studies and other aspects of the development program, regulatory documents or other clinical program activities as related to US objectives and medical strategy
Desired Education, Skills and Experience
- MD or DO degree (PhD or PharmD with specific, relevant experience will also be considered)
- At least 15 years of relevant academic, industry, and clinical experience with minimum 10 years in Medical Affairs and 3 years in an executive position, e.g. CMA, SVP or similar
- Previous relevant experience with product launches in oncology is required
- Ability to work effectively with commercial and R&D organizations, with a constructive, solution-oriented approach to bridge medical and commercial strategies
- A solid understanding of clinical study designs, including analysis and interpretation of preclinical, clinical and observational data
- Understanding of FDA, OIG, HIPAA and other ethical, legal and compliance guidelines relevant to the US and global territories, to ensure team compliance with these external as well as building internal guidelines and optimize existing standard operating procedures