The Medical Director, Phase IV will provide medical support for the Medical Affairs respiratory therapeutic areas, including cystic fibrosis. He/she will work closely with a cross-functional group that includes Research & Development, Commercial, Government Affairs, and Corporate Communications to ensure that scientific and medical strategies are aligned with broader corporate and patient needs. This person must have the ability to work effectively in a highly matrix environment and have a successful track record of developing project strategies and executing project details.
He/she is expected to have a strong commitment to achieving corporate objectives while maintaining the highest ethical, regulatory and scientific standards.
Key Responsibilities
- Strategic alignment of the Cystic Fibrosis program working cross functionally and partnering with other key functions at Vertex such as Commercial, Government Affairs, and Corporate Communications.
- Assist with public policy and regulatory interventions in the respiratory fields.
- • Participates in the development of Study Protocols, Investigator's Brochures, Clinical Development Plans and other key study documents in conjunction with other line functions and with minimal guidance
• Serves on cross-functional Study Execution Teams (SET) for assigned trials, working with other team members to achieve efficient, high-quality study execution
• Participates in the preparation of regulatory documents in support of regulatory submissions, including clinical section of IND’s and CTA’s, IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate
• Provides scientific and clinical input to study-related documents and analysis plans including Informed consent forms (ICF), clinical research forms (CRF), statistical analysis plans (SAP), clinical pharmacology analysis plans (CPAP), and clinical study reports (CSR)
- Responsible for medical interpretation of data (clinical trials, registries, published literature, etc.) for in-development and marketed compounds; review clinical trials and community based grants, as needed.
- Partner with KOLs to gather information on current focused therapeutic area issues and questions.
- Work closely with Vertex Medical Science Liaisons (MSLs) to provide appropriate education and training. Provide support, participation and insight in MSL activities, such as KOL interactions.
- Work with managed markets and Managed Care Liaisons (MCLs) to develop educational material relevant to payers.
- Assist the Commercial team with the development of education material for providers and patients that is medically accurate and appropriate.
- Possess understanding of government and industry guidelines, regulations, laws, etc., for appropriate scientific/medical exchange and communication with customers.
- Integration of Global Medical Affairs objectives with those of Clinical Development and Commercial operations to ensure programs meet the needs of all constituents. Minimum Qualifications - Possesses strong knowledge of pulmonary medicine, and in particular, strong depth of knowledge in cystic fibrosis (Pulmonary and/or Pediatrics experience preferred)
- At least 5-8 years of basic or clinical research experience in an academic or industrial setting, with experience in analysis of research data and publications; working knowledge of biostatistics and pharmacokinetics; working knowledge of GCP, scientific and clinical research methods and clinical study design, regulatory requirements for clinical studies
- Broad understanding of global Medical, Regulatory and Commercial environments
- Excellent strategic skills with the ability to influence decisions, both internally and externally
- Excellent written and oral communication skills; high-level negotiation skills
- Ability to work in a fast-pace and ever-changing environment, as well as the proven track record of working effectively in diverse teams involving multi-functional disciplines
- Proven ability to develop internal relationships in a highly matrix environment, as well as external relationships with Key Opinion Leaders and industry experts
- Possess the ability to engage in positive dialogues, influence outcomes and resolve conflicts in a constructive manner
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