Associate Director, Musculoskeletal Therapeutic Area In Vivo Lead

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Job description

Musculoskeletal Therapeutic Area In Vivo Lead, Associate Director About the job Who We Are
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, drug discovery and development, 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 people in need. Our Culture
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.

The Job Opening
We are seeking a highly motivated and agile Associate Director with experience in skeletal biology and disease to join our team as the Musculoskeletal Therapeutic (MSK) Area In Vivo Lead. The Associate Director will manage the portfolio of in vivo MSK studies across the Therapeutic Area as well as manage a team of in vivo staff focused on developing therapeutics for musculoskeletal diseases. This role reports into the Head of the Musculoskeletal Therapeutic Area with extensive interactions and partnership with the Head of Animal Resources. The successful candidate will advise on all in vivo aspects of the musculoskeletal research and early development portfolio. This role includes collaboration with external and internal scientists on research projects including in vivo study design, hands on in vivo study performance, selection and characterization of animal models, diligence on business development opportunities, as well as application of in vivo methods and techniques. This role includes regular project management including study report writing for FDA filings, writing IACUC protocols, communicating scientific strategy and results to leadership, monitoring in vivo studies and collaborating with CROs, tissue collection, and sample management.

The successful candidate will also have experience managing staff and be responsible for leading and developing the careers of a dynamic team of in vivo scientists while managing their allocation of effort in alignment with Research priorities. The ideal candidate will have a proven track record of managing a productive team, excellent communication skills, and commitment to developing leadership skills in themselves and others.

The ideal candidate will have extensive Postdoctoral Academic or Biotech/Pharma industry hands on in vivo experience in the skeletal biology/disease field. Experience in muscular disease is a plus. Experience in breeding colony management and familiarity with mouse model creation processes and techniques (e.g. CRISPR, Cre-lox and Tet-on systems, mouse IVF concepts) and familiarity with mutant model types (transgenic, knockout and knock-in models, conditional and traditional mutant lines) is highly desired. Additionally, proficiency with in vivo methods such as administration of test articles with various dosing techniques (IM, IP, IV, SC, PO), plethysmography, gait analysis, Computerized Tomography, Multiphoton microscopy, IVIS imaging, perfusion and tissue collection, blood collection, as well as rodent surgical methods is required. An ability to interpret and communicate the findings from these diverse methods is important. Candidate level at hire will depend on education and experience. Responsibilities:

Study Project Management:
• Effectively collaborate with both internal and external scientists on completion of musculoskeletal therapeutic area in vivo studies which includes CRO study placement/monitoring.
• Managing in vivo study projects including study design, sizing of cohorts, dosing, application of in vivo testing modalities, tissue collection, sample management, animal model selection, data analysis including statistics application, authoring study reports, and interpretation/presentation of scientific results.
• Provide projection on study project needs including budgeting, staffing, and scheduling.
• Align in vivo team priorities with the priorities of the MSK TA and Research.
• Execute hands-on responsibilities including, but not limited to animal handling and restraint (rodents), administration via various routes of administration, including intravenous (tail-vein), in-life animal health monitoring and measurements, clinical observations, sample collection and processing, and accurate data collection. In addition, providing daily care and monitoring of mice or rats, including health checks and documentation, will also be required.
• Effectively collaborate with other in vivo leads from other therapeutic areas to ensure portfolio project study prioritization. This includes working with other units to share equipment and staffing as needed.
• Follow all institutional, local, and federal regulations regarding animal care and use. Adhere to safety protocols and maintain a clean and organized work environment. Maintain detailed and accurate records of all procedures and animal health status including adverse study events. Meticulous electronic lab notebook documentation.
• With minimal guidance, collect, analyze, interpret, and present data within the Musculoskeletal Therapeutic group and across functional areas within the company.
• Communicate experimental plans and results to the leadership team. Support product development and regulatory filings for pivotal clinical studies.
• Follow instructions and work independently to effectively manage time and prioritize tasks to ensure all assignments are completed on or before deadlines.
• Must have excellent troubleshooting, organization, and planning skills, and the ability to work under timeline in a fast-paced environment.
• Excellent written and oral communication skills to effectively share scientific findings.
• Excellent documentation skills including maintenance of daily records using Electronic Lab Notebooks and generation/maintenance of technical procedure documents and SOPs.
• Willingness to work on site full time including off hours and weekends based on study needs.
• Other duties as assigned. Staff Management and Training:
• Training technical staff on all aspects of in vivo study management.
• Oversight of in vivo technical staff performance of in vivo studies in the musculoskeletal therapeutic area.
• Provide developmental opportunities for in vivo technical staff to support their career growth
• Responsible for scheduling of study technical staff to ensure timely completion of in vivo studies.
• Responsible for oversight of accuracy of technical staff data collection and analysis.
• Provide musculoskeletal in vivo group yearly goals, objectives, and key results aligning with study and project company needs.
• Provide technical staff performance management and feedback.
• Other duties as assigned. General requirements for the position:
• Demonstrated experience in skeletal biology/disease or muscular biology/disease research in academia or industry (preferred) including publication record.
• Strong analytical, problem-solving, and decision-making skills.
• Strong understanding of genetically engineered models, breeding, and management and Gene therapy modalities.
• Excellent oral and written communication skills.
• Passion for contributing your scientific skills to develop therapies for patients in need.
• Must be able to utilize computer databases for analysis, data entry, and point of care observations.
• Must be able to work under time constraints with minimal direction of day-to-day responsibilities, including collaboratively working with multidisciplinary teams.
• Must be able to regularly read, understand, verify accuracy, and document various written of protocols, including Animal Care and Use Protocols and Standard Operating Procedures.
• Must be able to work with external regulatory agencies and accreditation groups.
• Some "off-core business hours" work required.
• Complete all company training requirements.
• Perform all work per designated safety standards and comply with Personal Protective Equipment requirements and occupational health to perform work tasks.
• This position is an on-site critical required position.
• Other duties as assigned. Education and Experience Requirements:
• PhD in a related subject area with demonstrated research experience in skeletal biology.
• Postdoctoral or previous industry experience in skeletal biology (7+years) . click apply for full job details

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