The Associate Medical Director, Global strategy will provide medical support for the Cystic Fibrosis therapeutic area, and will be responsible for supporting development of the medical strategy and medical plan as well as executing against the medical plan. He/she will work closely with the Medical Director and cross-functional group that includes Clinical Development, North American and International Medical Affairs organizations, HEOR/Market Access, Marketing, Regulatory, and Medical 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 matrixed environment and have a successful track record of developing project strategies and translating and executing tactics. He/she is expected to have a strong commitment to achieving corporate and medical objectives while maintaining the highest ethical, regulatory and scientific standards.
- Support strategic alignment of the assigned clinical program/product working cross functionally and partnering with other key functions as outlined
- Provide input and contribute to the global Therapeutic Area strategic imperatives, Medical Affairs objectives and annual brand tactical plans
- Support development of Study Protocols, Life Cycle Management Plans and other key study documents in conjunction with other line functions and with limited guidance
- Support cross-functional study execution teams (SET) for assigned studies, working with other team members to achieve efficient, high-quality study execution and to function as medical lead for global phase 3b/4 clinical trials.
- Participate and support the preparation of regulatory documents in support of regulatory submissions, including clinical section of INDs and CTAs, IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate
- Contribute towards medical interpretation of data (clinical trials, registries, published literature, etc.) for the assigned product(s)
- Provide scientific and clinical input to study-related documents and analysis plans including Informed consent forms (ICF), clinical research forms (CRF), statistical analysis plans (SAP), and clinical study reports (CSR)
- Work with the Global Communications team to support development and execution of aligned strategies/tactics for maximizing our scientific communication efforts.
- Serve as promotional reviewer for global commercial pieces.
- Partner with global thought leaders to provide insights on current focused therapeutic area issues and questions
- Support and executing Steering Committee meetings and advisory boards.
- Partner with external investigators on collaborative studies and with external registries on non-interventional studies using secondary data.
- Support review of investigator-initiated proposals and other research grants.
- Provide medical input and guidance to Early Access Programs and individual IND (early access) requests.
- MD, DO or equivalent ex-US medical degree (non-MD candidates with doctoral degrees may be considered if they have an appropriate professional background)
- Board certification/eligibility in pulmonary, gastrointestinal medicine, infectious diseases, or another relevant medical field, is highly desired; clinical Cystic Fibrosis experience is a plus
- At least 3 - 5 years of 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
- Excellent oral and written communication skills
- Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate
- Global clinical research experience and experience interacting with regulatory authorities is a plus