Role Summary:
The Director of Medical Affairs supports medical affairs strategy, project execution, compassionate use programs and investigator-initiated clinical trials, publication strategy, and medical communications. This role advances patient care by engaging in scientific exchange with external medical and scientific experts and industry professionals ensuring the scientific value of our products is realized. This role will also participate in scientific interactions with the medical community, help to drive clinical trial awareness and execution, and coordinate medical and scientific publication activities, translating current and emerging evidence into content of value for internal and external audiences.
The Director of Medical Affairs works closely with cross-functional commercial, scientific, and development teams to support clinical development programs and help to ensure cross-functional alignment.
Essential Duties and Responsibilities
:
- Help create and implement product medical affairs strategy and execution including medical expert engagement and development, compassionate use programs, investigator-initiated trials (IITs), publications, medical education, and medical communications.
- Ensure medical affairs compliance processes are followed.
- Contribute to excellence in the communication of medicine and evidence generation strategies, implementation of global scientific engagement programs and gathering insights from external stakeholders (patients, physicians, payers, and regulators).
- Participate in financial planning and working within planned scope, in relation to annual budget cycles.
- Seek relevant scientific / medical insight from stakeholder groups, including HCPs and patients.
- Identify gaps and opportunities from the complexity and volume of emerging data.
- Consolidate scientific and medical content for key internal and external stakeholders.
- Help define needs and strategies to develop evidence for the asset.
- Ensure appropriate interaction and exchange of scientific information in adherence with scientific engagement principles and standards, locally and globally.
- Discuss scientific issues related to mechanism of action, clinical development, study design, data interpretation, study conclusions, and protocol recommendations.
- Implement global publication strategy in collaboration with R&D clinical, translational, and nonclinical teams.
- Develop promotional, non-promotional and training materials, as appropriate for the stage of the asset.
- Drive excellence in external engagement with key stakeholders (e.g., HCP’s, Patients, Payors and Regulators) globally and in partnership with key countries.
- Travel up to 30% time, based upon program needs
Education and/or Work Experience Requirements:
- MS or higher degree in a scientific discipline with at least 10 years of relevant medical affairs, medical communications, or similar experience.
- MD/PhD/PharmD preferred.
- Experience with publication planning and execution and/or medical education and scientific communication desirable.
- Knowledge of relevant regulations impacting medical affairs activities
- Highly developed networking, communication and influencing skills to work effectively in a matrixed environment.
- Excellent presentation and communication skills for both internal and external audiences.
- Demonstrated track record of quality decision making and problem resolution based on assessment of all relevant supporting and conflicting information/factors and understanding of the wider context.
- Able to present complex data to diverse groups. Makes medical information/concepts accessible for non-physicians.
- Highly developed influencing skills and ability to influence others to make sound decisions from a medical point of view by providing clear medical information.
- Demonstrated ability to prioritize multiple tasks and deliver to deadline with high standard of quality.
- Contributes innovative ideas to address new issues or improve approaches to existing operations.
- Ability to adjust behaviors and priorities based on changing environment.
- Highly motivated, decisive, and results-oriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing company.
Fore Biotherapeutics is an Equal Opportunity Employer. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
