Sr. Medical Director, Clinical Science
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.
BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class or best-in-class therapeutics that provide meaningful advances to patients. Come join our team and make a meaningful impact on patients’ lives.
BioMarin Clinical Science (CLS) is responsible for overseeing clinical programs across various phases, from proof-of concept to Phase 3 and BLA/NDA/MAA filing. The Clinical Science team provides leadership for clinical strategy and oversight to ensure excellence in clinical trial conduct, data analysis and interpretation, publication preparation, and safety monitoring.
The Senior Director (SD)/ Sr. Medical Director (SMD) has a key scientific and analytical leadership role in the development of Clinical Science core deliverables across program planning, study design and execution, results analysis and regulatory filings. The SMD/SD will be accountable for the day-to-day Clinical Science deliverables for an assigned clinical development program. Focus areas include: taking the role of Clinical Science Lead in activities to support the scientific strategy that serves as the basis for the Clinical Development Plan (CDP); acting as a study Medical Monitor/ Clinical Scientist, which includes providing scientific input into study design/development, review of all Clinical Science study deliverables, monitoring study data and and contributing critically to the scientific interpretation and integration of clinical study results. The SD/SMD may also take on key leadership roles in department wide initiatives.
The SMD will also demonstrate advanced clinical and therapeutic area knowledge to support clinical decision making, problem solving, and safety surveillance, as well as collaboration with external physician stakeholders.
The SD/SMD may take on leadership responsibility for leading a cross functional clinical development team for a program that is earlier in the development lifecycle or with a smaller number or studies planned or underway.
The SMD / SD will also mentor team members and establish a team environment that fosters the development of high-quality deliverables; identify, assess, and mitigate risks; and drive decision making as it relates to the CDP.
Responsibilities may include, but are not limited to:
Scientific planning and oversight:
- Lead the definition of the core clinical and scientific strategy that serves as the basis for the CDP in support of the IPP, TPP and lifecycle plan
- Keep up-to-date on relevant medical literature and developments in a therapeutic area
- Oversee or participate (as assigned) in the development of clinical science assigned sections of regulatory filings and in drafting regulatory responses in collaboration with Medical Writing
- Provide clinical science perspective and expertise on product approaches, unmet needs, and strategy, including for global approval inquiries following health agency review
- Provide strategic or technical input on clinical study proposals under the purview of GMAF, where appropriate
- Lead the development of scientific messaging content in partnership with Medical Writing, providing in-depth review of clinical study results
- Review and provide comments on company- sponsored abstracts, manuscripts and publications of original research and press-releases related to assigned product/program, as requested
- Establish relationships with investigators and KOLs as appropriate in support of the CDP
Clinical Study Planning and Monitoring:
- Act as the medical and scientific subject matter expert, and primary contact, for assigned clinical study; take a proactive approach to identifying issues and mitigating risk
- Participate in the development and review of trial concept sheets, investigator brochures, protocols and protocol amendments, CSRs and other summary documents
- Initiate and provide the medical and scientific content and insight for development and review of study documents including ICFs, CRFs, statistical tables and listings including accurate AE (MedDRA) and concomitant medications (WHODrug) coding and inspection readiness activities
- Provide clinical input to statistical analysis plan to ensure alignment with Regulatory and business interests
- Act as study scientific subject matter expert and main point of contact for Principal Investigators (PIs) and sites to assess subject eligibility, provide scientific rational and manage ongoing protocol issues
- Provide leadership to sites by developing or participating in training, and answering investigator/site questions about the protocol
- Conduct periodic review of protocol deviations in collaboration with Clinical Operations Study Lead or designee (per protocol specific Protocol Deviation Plan)
- Attend and present at Investigator Meetings, as needed
- Collaborate with Biometrics to identify key issues, prepare content and facilitate discussions at study Data Review Board (internal) or Data Monitoring Committee (DMC)
- The SMD will also act as the medical subject matter expert for review of clinical and safety data to ensure data are correct and presented with the appropriate medical interpretation and for discussing safety concerns with sites.
Governance and communication:
- Lead and facilitate Protocol Working Teams under purview of CDP and participate in relevant Clinical Development Team partner teams
- Provide leadership and guidance to CLS Medical Monitors associated with studies under the purview of the CDP
- Act as an escalation point for Medical Monitors for any issues that impact CLS deliverable quality, timelines or budgets
- Coordinate review and input of the clinical study documents with the Protocol Review Committee (PRC). This may be done in collaboration with the CDTL.
- Participate in and contribute to CDT meetings, including tracking and sharing of meeting minutes
- Ensure timely and effective communication among the CDT, Clinical Science management, and the SET Medical Monitor(s)/Clinical Scientist(s), as appropriate
- Participate in review and distribution of study update reports to management and other key stakeholders (i.e. monthly study reports, presentation at team meetings)
- In collaboration with GMAF, coordinate the provision and sharing of external advice/expertise through KOL interactions, global steering committees and scientific advisory boards, as needed
- The Sr. Director / Sr. Medical Director is expected to exhibit advanced-level competence in leadership as well as mastery-level understanding of all other CLS core and technical competencies, including communication, problem solving, proactivity, drug development, regulations, and compliance. This role:
- Communicates and reinforces purpose and links between CLS functional activities and BioMarin corporate strategy and financial results
- Actively models and encourages open, honest and clear communication across teams and functions
- Looks externally, in industry and outside of industry, for best practices that can be leveraged in solution development
- Understands and utilizes in-depth knowledge of the functional area, business strategies, and the company’s goals to mitigate risk or resolve issues.
- Understands and communicates big picture implications and considerations of drug development strategies on corporate objectives and business results
- Can effectively represent the department during inspections and responds effectively to agency inquiries
The SMD will also demonstrate mastery of relevant clinical and therapeutic area knowledge to support clinical decision making, problem solving, safety surveillance, and as well as collaboration with external physician stakeholders.
The Sr. Director / Sr. Medical Director may manage one or more employees.
Education & Experience:
- Medical Director: MD, MD/PhD (or equivalent)
- Director: Advanced degree in life or health sciences (e.g. PhD/PharmD/RN)
- 6 or more years of relevant experience in genetic diseases, metabolic diseases, specialty care, and/or rare diseases desired; Clinical experience preferred
PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.
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.