About This Role:
The Clinical Development Lead Immunology based within Biogens West Coast Hub (WCH) will provide strategic leadership to advance our Immunology programs ensuring innovative clinical development approaches and well-informed trial designs. Operating at the intersection of program strategy disease-area insight and clinical execution you will partner closely with Medical and Clinical Development leadership to translate strategy into high-quality development plans. Your role is pivotal in managing external collaborations and gaining comprehensive knowledge of current literature related to the indications and products in development. Supporting regulatory interactions and collaborating with Medical Affairs and Commercial colleagues are integral parts of your responsibilities.
The scope of this role may emphasize program strategy and execution or disease-area strategy tailored to your strengths experience and portfolio needs.
What Youll Do:
Contribute to the development and execution of clinical development strategies for immunology programs across early through late-stage development.
Inform clinical trial design decisions including patient populations endpoints duration and feasibility considerations.
Support the development and maintenance of Clinical Development Plans (CDPs) in partnership with Clinical and Medical Development leadership.
Translate scientific clinical and external precedents into clear strategic recommendations to guide program decisions.
Partner cross-functionally to ensure alignment between strategy and execution.
Lead or co-lead protocol development amendments and supporting documents as appropriate.
Prepare materials and contribute to discussions for development governance forums and senior leadership reviews.
Support disease-area strategy development and external engagement through scientific and clinical narratives.
This position is a hybrid-based role in South San Francisco CA. Consideration may be given to individuals able to commute to CA regularly from US-Remote locations.
Who You Are:
You are a curious strategic and collaborative clinical development leader who thrives in ambiguity and continuously seeks to learn and improve. Passionate about improving the lives of patients with immune-mediated or autoimmune diseases you excel in translating complex scientific and clinical information into actionable development strategies. You have the ability to influence without authority and partner effectively across disciplines. Experienced in framing trade-offs and decision points for senior leadership you are adaptable able to flex between program-level strategy and disease area depth as needed.
Required Skills:
MD PhD or PharmD is required with experience in immunology inflammation or autoimmune disease drug development.
3 years experience in clinical development translational science or related roles within biotech or pharmaceutical organizations.
Experience contributing to clinical development plans protocol design and cross-functional development activities.
Strong communication and stakeholder management skills.
Deep understanding of regulatory requirements for drug development.
Excellent communication skills with the ability to effectively communicate complex medical and scientific information to diverse audiences.
Strong interpersonal skills with the ability to establish and maintain relationships with key opinion leaders clinical investigators and internal stakeholders through a highly collaborative approach.
Preferred Skills:
Relevant disease area experience (e.g. Graves disease/endocrinology neuroimmunology or other immune-mediated conditions) and/or experience in asset- or program-level strategic leadership is a plus.
Additional Information
Base salary offered is determined through an analytical approach utilizing a combination of factors including but not limited to relevant skills & experience job location and internal equity.
Regular employees are eligible to receive both short term and long-term incentives including cash bonus and equity incentive opportunities designed to reward recent achievements and recognize your future potential based on individual business unit and company performance.
In addition to compensation Biogen offers a full and highly competitive range of benefits designed to support our employees and their families physical financial emotional and social well-being; including but not limited to:
Why Biogen
We are a global team with a commitment to excellence and a pioneering spirit. As a mid-sized biotechnology company we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning growth and expanding their skills. Above all we work together to deliver life-changing medicines with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds cultures and perspectives make us a stronger and more innovative company and we are focused on building teams where every employee feels empowered and inspired.Read onto learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex gender identity or expression sexual orientation marital status race color national origin ancestry ethnicity religion age veteran status disability genetic information or any other basis protected by federal state or local law. Biogen is an E-Verify Employer in the United States.
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities, ... View more