Head of Early Programs
Location United States, RemoteWorkstyle Remote Only Apply
For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more.
And the more people we reach, the more our impact can grow. We transform lives through genetic discovery.
Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard – so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients.
The Head of Early Programs is a leadership position responsible for the portfolio of programs from initiation of investigational new drug (IND) to completed proof of concept (POC) studies. This position is responsible for the clinical oversight of all early clinical studies, and the articulation of the strategic goals of early development.
BioMarin plans to support 2 new INDs and 2 completed POCs each year based on a development track record of success. BioMarin is a genetic medicines company with a broad therapeutic portfolio and multiple treatment modalities including viral and non-viral gene therapy, oligonucleotides for gene targeting, biologics, and small molecules.
This position reports to the newly created senior position of Head of Experimental Medicine and Early Clinical Development and will be a critical function in the continued growth and diversification of the clinical development pipeline of BioMarin. This role will have key strategic interfaces internally with Late-Stage Development, Translational Sciences, and the Product Portfolio Team amongst others. Externally, this position is expected to be a dynamic catalyst for support of the pipeline and help build strong relationships with world class key opinion leaders. Success requires sound understanding of the evaluation of the scientific programs, translational results, development of key mechanistic endpoints, and leveraging early studies to understand therapeutic margins and estimates of effect size. This role is expected to contribute to portfolio growth and strategy in the context of market assessment and competitive analysis.
This position will have oversight and responsibility for all Early Clinical Development (ECD) functions:
- Manage a motivated group of physician-scientists engaged in the programs. within the ECD portfolio, with an expectation to scale and build the team.
- Author strategic content of clinical development plans and protocol development for ECD.
- Advancement of programs to support corporate growth goals.
- Cross-functional collaboration with Regulatory to author strategy for first in human studies.
- Develop key internal and external stakeholder collaborations.
- Representation of ECD at key research and development governance forums.
- Lead teams responsible for designing and executing early clinical programs.
- Contributions in cross-functional setting Identify therapeutic targets, disease mapping and pipeline strategy.
- Synthesize and communicate results/outcomes of early clinical studies.
- Assimilate advancement of early studies into the assessment of risk and investment in programs.
- Lead external advisory process for new development programs and develop high level KOL support for key programs.
- Regular interactions with senior research, senior leaders in business development, research and commercial to align development goals with functional and corporate initiatives.
The Head of Early Programs will be a member of leadership teams in Translational Science, Clinical Development, and participate in governance and strategic forums. This role is expected to maintain highest scientific and ethical integrity, manage publication and communication plans. The development of disease mapping, patient centered outcomes, and integrated evidence plans for a diverse portfolio in a cross-functional is considered a key deliverable. The Head of Early Programs is at the nexus of translational and clinical research, leveraging detailed scientific, genetic, translational, and phenotype information into a development plan that supports data-rich advancement decisions for the early portfolio.
This is a leadership and management role of significant impact to the growth of the development organization. Commensurate with the intended impact of this role, candidate must be a thoughtful and mentoring manager. In addition, they must also have excellent technical understanding of science and development. The candidate must be facile communicating technical and corporate initiatives to key external thought leaders and partners.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.
In the U.S., the salary range for this position is $ 296,000 to $ 444,000 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.