- Will report to a more senior member of the immunology-rheumatology clinical team who has direct responsibility for the overall research strategy and clinical and scientific development activities.
- Will lead conceptualization and development of clinical trials in conjunction with multiple functions, including development from inception of trials in new indications.
- Drive development of clinical development plans and protocols for clinical studies;
- May serve on one or more study management teams as a clinical development functional area leader, participating in all aspects of trial execution as required, including presenting at clinical study investigator meetings, monitoring and reviewing incoming safety &efficacy data, engaging with study physicians, reviewing final data outputs and other activities as needed.
- Provide ongoing medical expertise and medical oversight of clinical trials, including eligibility evaluation and toxicity management, in conjunction with external and internal partners.
- Prepare and/or provide input to clinical study related and other regulatory documents (e.g. CSRs, IBs, PIS/ICFs, SAPs, Data Management Plans, IND, briefing books);
- Provide clinical scientific input to business development (e.g. due diligence);
- Provide medical leadership for programs that integrate the individual’s knowledge in in basic science, drug development, and medical practice with input from the medical community around the world.
- Develop and deliver presentations to internal and external stakeholders.
- Elaborate and integrate the scientific and clinical rationales, regulatory requirements to support buidling a solid Clinical Development Plan (CDP), including appropriately aggressive clinical development timelines, incorporating key decision points and Go/No Go criteria for each CDP.
- Must ensure adherence to all requirements of good study conduct and standards of Good Clinical Practice.
- May interface with key medical experts and represent the team at medical congresses and conferences.
Biogen is excited to expand the immunology space and add depth to their Clinical Development Team. The ideal candidate will have the following mix of professional and personal characteristics:
- MD/MD-PhD with Immunology-Rheumatology training, ideally with a clinical background in Lupus.
- Five (5) years of experience including clinical research in academia and progressive responsibilities in drug development in industry (clinical trial experience mandatory). Industry experience in immunology, specifically Lupus strongly preferred.
- Capacity and willingness to work effectively across disease areas.
- Demonstrated leadership and team building skills as well as the ability to perform effectively in a dynamic environment.
- Ability to compile and present development plans, study designs, analyses of data in forums consisting of individuals representing a variety of functions (eg, both with and without scientific backgrounds).
- Excellent communication skills (oral and written) and excellent organizational skills.
- The ability to lead directly and by influence, including strong problem solving, conflict resolution, and analytical skills. Must be able to work with minimal supervision.
- Ability to represent the department on project teams, committees and at external meetings.
- Able to work collaboratively in a multi-disciplinary team setting and employ a team approach to decision-making.
- Ability to balance multiple competing demands and meet aggressive timelines.
- Scrupulous attention to detail, clear ability to think critically, establish and maintain rapid timelines, and persistent commitment to ensuring a high level of quality.
- Ability to travel domestically and internationally to company, scientific, regulatory, investigator, and other meetings (~20%-30% potential travel, within current COVID-19 regulation).