Greater Boston Area
CC- Medical Director Rare Disease
2 months ago
The Medical Director is the clinical leader of ongoing clinical development programs including work in Phase 1 to Phase 3 programs. They will contribute to other activities such as regulatory submission activities, briefing books etc. As a key contributor and medical leader of the cross-functional clinical team leads the medical strategy and support of the ongoing clinical trial(s) end-to-end to achieve overall business objectives. They will be responsible for planning, developing, executing and analyzing clinical study programs. This role will be a key contributor in building an integrated development plan and will provide support and expertise to new development activities, as well as clinical guidance and assessment of future opportunities in collaboration with the Medical Director, Medical Affairs to advance the science and address unmet needs in Clinical Development. The individual will be a self-starter with excellent clinical capabilities and who is seeking to be part of an innovative team that will drive the drug development processes from start to finish.
This role reports to the VP, Clinical Development and Medical Affairs.
• Provides clinical leadership, strategic input and medical and scientific review for all clinical deliverables in the assigned project or section of a clinical program if applicable, including regulatory documents. Clinical deliverables may include clinical sections of individual protocols or sub-studies consistent with the Clinical Development Plans (CDP), clinical data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications
• Drives execution of the section of the clinical program in partnership with other line functions (eg, Development Operations), and regional/country medical associates, if applicable.
• Medical Lead of the Clinical Trial Team(s) for ongoing and planned programs. Represents the section when needed in Senior management Team meetings, and as the section spokesperson in internal and external meetings/boards, as needed.
• Ensures compliance with GCP, SOPs, Business Practice Guidance and regulatory requirements as contributes to trial level budget plan and forecast being owner of and accountable for clinical work package.
• Ensures overall safety of the molecule, may be a core member of the Safety Management Team (SMT), and supports overall program safety reporting (e.g., Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with Associate director clinical Safety.
• May lead / support interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal stakeholders (e.g., Research, Translational Medicine, Global Medical Affairs, Marketing, HE&OR), and internal decision boards.
• Take a leadership role in proposal development to identify effective clinical and regulatory implementation strategies that are efficient in time and money, and hedge risk as needed.
• Provide hands-on participation in the clinical program and trial development process; conceive and execute clinical strategy and contribute clinical expertise for research and development projects in highly competitive therapeutic areas
• Assist in preparation of clinical sections of all relevant documents and regulatory filings (Investigator’s Brochures, INDs, and study reports)
• Assure implementation of latest scientific and clinical thinking as well as guidelines into the clinical development plans, including through interaction with key opinion leaders
• Serve as clinical and technical resource for clinical issues raised by internal and external collaborators, investigators, consultants and contract resources
• Provide input to and review study start-up documentation, e.g. study protocols, CRF design, source data verification plans based on protocol specifications
• Attend and provide scientific support for investigator and consultant meetings and other study implementation workshops
• Assist in the development of publications, abstracts, and presentations
• Provides safety surveillance guidance, acts as a medical monitor, and ensures adherence to cGCP requirements and all applicable regulatory references and guidelines • Participate in pre-submission, pre-market and other meetings with the FDA and other regulatory agencies, as needed
• Manage outside consultants (consultants, etc.) to ensure data is accurately collected and analyzed in a cost-effective fashion Qualifications
• MD degree required. Advanced knowledge and training in a medical/scientific area (e.g. Infectious diseases or oncology, Internal Medicine) Board eligibility required, with Medical Board certification preferred;
• Clinical practice experience ≥ 3 years (excluding residency) preferred
• ≥ 5 years of involvement in clinical research and drug development in an academic plus industry environment
• ≥ 3 years’ experience of global clinical development, especially in EU and USA, contributing to all aspects of designing and conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry
• Experience in interactions with Health Authorities (e.g. FDA, EMEA, PMDA...)
• Early and late stage drug clinical development experience preferred
• Pediatric Clinical trial and PIP experience and Orphan Drug Designation experience a plus
• Demonstrated ability to establish strong scientific partnership with key stakeholders and work in a matrixed multifunctional environment
• Thorough knowledge of GCP, clinical trial design, statistical analysis methodology, and regulatory/clinical development process.
• Must have experience designing successful clinical studies in complex diseases requiring the management of patient variation. Must be facile with statistical issues and be able to manage working with a statistician to design the analysis of clinical studies. Required
• Proven leadership experience and able to work both independently and as a member of an integrated, interdisciplinary team in carrying out assigned responsibilities.
• Must be analytical and articulate in both oral and in writing skills, with a demonstrated ability to communicate well with others at varying professional levels, especially in the medical profession.
• Ability to write clinical study reports and summaries for regulatory purposes
• Ability to effectively present information and respond to questions from groups of managers, clients, customers and the general public