Senior Director, Translational Science
Job Description
Description
The Senior Director, Translational Science leads translational and nonclinical development activities in support of candidate selection, clinical development, and product registration of Pacira portfolio programs. The Senior Director, Translational Science is responsible for the design, conduct, analysis, and reporting of pharmacokinetic (PK), toxicokinetic (TK) and pharmacodynamic (PD) assessments, biomarker development and analysis validation, biodistribution studies, and leads the strategic plan for these studies. This position interacts with internal and external stakeholders, including regulatory authorities to ensure appropriate communication of all translational science study strategy, results, and conclusions.
About Pacira
Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients. Our in-depth knowledge of non-opioid pain management, coupled with our passion for advancing patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical results.
Why work with us?
Rarely do you have an opportunity to do work that really matters. What drives us is our mission. What makes us successful are our people. At Pacira, you are part of an inclusive culture that fosters collaboration, growth, and innovative thinking - a place where you can make an impact and help change the standard of care in non-opioid pain management. Be part of our movement, let's pursue excellence together.
Summary:
The Senior Director, Translational Science leads translational and nonclinical development activities in support of candidate selection, clinical development, and product registration of Pacira portfolio programs. The Senior Director, Translational Science is responsible for the design, conduct, analysis, and reporting of pharmacokinetic (PK), toxicokinetic (TK) and pharmacodynamic (PD) assessments, biomarker development and analysis validation, biodistribution studies, and leads the strategic plan for these studies. This position interacts with internal and external stakeholders, including regulatory authorities to ensure appropriate communication of all translational science study strategy, results, and conclusions.
Essential Duties & Responsibilities:
The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job. Other duties may be assigned.
The Senior Director of Translational Science will drive all aspects of the translational strategy, including pharmacokinetic (PK), toxicokinetic (TK) and pharmacodynamic (PD) assessments, biomarker development and biodistribution studies, and will be accountable for delivering key translational milestones from candidate selection to product registration.
Scientific Leadership and Communication
- Establish and execute the strategic direction and design of the company's translational safety and pharmacology plans, with a deep understanding of cell and gene therapy platforms
- Identify significant issues and risks that may impact overall project plans and initiate contingency plans as appropriate
- Ensure appropriate scientific rigor and regulatory compliance in the design, conduct, validity, and interpretation of non-clinical data to support clinical programs and regulatory applications
- Provide scientific oversight and CRO management for translational IND enabling studies, including exploratory and GLP PK/TK studies, PD and biomarker development and analysis validation, biodistribution studies, and development of assays for Anti-Drug Antibody (ADA) assessment
- Establish PK/PD endpoints for appropriate sampling of clinical protocols, development of molecular assays and advancement of phase appropriate programs
- Responsible for the strategic planning, authoring, and review of the translational biology components of regulatory documents, scientific data, and publications
- Contribute to scientific and clinical interface with key opinion leaders (KOL), facilitating KOL advocacy development
- Represent Translational Science when presenting to project and corporate governance meetings
Collaborate and Mentor
- Lead the Translational Science function, while collaborating with internal and external teams to progress the understanding of the biology behind clinical trials and PK/PD data as necessary
- Identify and collaborate with academic investigators to optimize the translational strategy and plans for programs
- Engage with clinical development teams to inform execution of translational sciences programs including development and validation of product specific clinical assays
- Lead or participate in cross-functional working groups such as scientific and safety review boards
- Mentor and develop an interdisciplinary development team, fostering a culture of innovation and scientific rigor in a highly matrixed work environment
- Manage CROs and scientists that will be interfacing with Research and Development groups as new therapies are advanced
- Contribute to departmental resource planning, budgeting and timeline setting to meet company needs
Supervisory Responsibilities:
This position may have supervisory responsibilities.
Interaction:
The incumbent works closely with internal teams and vendors.
Education and Experience:
- A PhD degree with a minimum of 10 years of, or a master's degree with a minimum of 15 years of, combined academic and biotechnology or pharmaceutical experience in Non-clinical Research, and/or Translational Sciences, including experience in genetic medicine, immunology, inflammation, and/or pain research
- Prior experience in translational science with in-depth knowledge of PK, TK, and PD principles, biomarker development, and biodistribution studies, as well as a significant publication track record supporting this experience
Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily and work independently, planning their time to meet both short-term and long-term objectives. The requirements described above are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Knowledge, Skills, and Abilities:
- Deep understanding of and direct experience in immunology, inflammation, and/or pain pharmacology, in both early and late stages of development
- Demonstrated ability to integrate scientific rationale, target biology, clinical strategy, and target product profile to develop appropriate translational strategies
- Strong understanding of the regulatory requirements for translational research and drug development
- Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication for internal and external use
- Outstanding communication skills with the ability to effectively converse with a variety of audiences including team members, cross-functional project teams, project leaders, KOLs and senior management
- General familiarity with biostatistics and/or pharmacometrics; expert in navigating scientific literature, interpretation of data, display of data
- Excellent interpersonal relationship and people skills
- Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in a fast paced, innovative and performance driven environment
- Attention to detail, experience in monitoring work to assure quality, accuracy, and thoroughness
- Comfortable challenging the status quo and bringing forward innovative solutions to make better possible
- Strong commitment to ethical standards
- Ability to travel up to 20%
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit, talk, move between spaces, reach with hands and arms and stoop. Close vision and the need to focus on computer screen, use of hands, fingers, and wrist to type on keyboard and manipulate mouse. Will need to lift and move items weighing up to 40 pounds.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
The work setting is consistent of a typical pharmaceutical office environment with production areas, offices, and cubicles.
Benefits:
- Medical, Prescription, Dental, Vision Coverage
- Flexible Spending Account & Health Savings Account with Company match
- Employee Assistance Program
- Mental Health Resources
- Disability Coverage
- Life insurance
- Critical Illness and Accident Insurance
- Legal and Identity Theft Protection
- Pet Insurance
- Fertility and Maternity Assistance
- 401(k) with company match
- Flexible Time Off (FTO) and 11 paid holidays
- Paid Parental Leave
EEO Statement: Pacira is proud to be an Equal Opportunity Employer and does not discriminate against applicants because of race, color, religion, sex (including gender identity, sexual orientation, and pregnancy), national origin, age (40 or older), veteran status, disability or genetic information, or any other characteristic protected under applicable federal, state, or local law. At Pacira we are committed to intentionally cultivating a culture of inclusion where all feel welcomed and valued for their background, perspectives, and experiences. We hold one another accountable to promote trust and transparency in support of our communities and collective purpose.
Agency Disclaimer: Pacira Biosciences, Inc. (Hereafter, Pacira) does not accept unsolicited resumes from recruiters or employment agencies in response to the Pacira Careers page or a Pacira social media post. Pacira will not consider or agree to payment of any referral compensation or recruiter fee relating to unsolicited resumes. Pacira explicitly reserves the right to hire said candidate(s) without any financial obligation to the recruiter or agency. Any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of Pacira.
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