Careers

The Senior Director, Clinical Pharmacology will co-function as a subject matter expert supporting all nonclinical, DMPK and clinical pharmacology development for small molecule oral drugs in development in the Oncology therapeutic area. The Senior Director, Clinical Pharmacology will co-determine and execute on strategy for DMPK and clinical pharmacology studies, including an assessment of required studies, gap analysis, vendor selection and oversight, and data interpretation. This individual will develop strategy and work with vendors on clinical pharmacology studies including BA/BE, DDI, popPK, PBPK and E-R modeling. This role will include the co-authoring of nonclinical, PK and clinical pharmacology modules of NDA, MAA, etc. This is a remote-based position.

• Work independently and with project teams to develop and execute clinical pharmacology development programs, PK/PD modeling and/or bioanalysis of PK samples
• Analyze, summarize and interpret nonclinical and clinical pharmacology data and/or integrate study results into the ongoing clinical development strategy
• Co-manage external vendors/CROs involved in the clinical studies
• Aid in the design plans to support regulatory filings such as eCTD/NDA etc.
• Participate in authoring and review of PK and clinical pharmacology sections of regulatory documents (e.g., protocols, SAPs, CSRs, IBs) and responses to regulatory agencies

• PhD in pharmacokinetics, clinical pharmacology, pharmacometrics, drug metabolism, pharmacology or related discipline
• Minimum of 15 years overall experience including 5 to 7+ years of research and development experience with at least 5 years within the pharmaceutical industry, at least some of which has been in start-up environment, with demonstrated experience in advancing clinical pharmacology studies through clinical development
• FDA experience preferred
• Must be hands-on as well as strategic
• Proven solid experience with managing clinical pharmacology vendors/CROs
• Hands-on experience with population PK, PBPK and E-R modeling
• Hands-on experience in co-directing strategy and authoring nonclinical, PK and clinical pharmacology modules of NDA and MAA
• Oncology small molecule experience preferred
• Excellent oral and written communication skills
• Strong leadership skills preferred
• Ability to demonstrate Elevar’s core values by holding ourselves and each other accountable for the work we do, taking time to collaborate effectively while working remotely, making space for ingenuity in work and thought, and staying grounded in compassion

The anticipated annual base salary range for this role is $210,000 to $280,000. Final compensation depends on multiple factors including but not limited to, relevant experience, skillset, depth and breadth of knowledge, internal equity, and external market factors. Elevar Therapeutics is a rapidly growing biotech company that offers competitive wages and benefits package including medical, dental, vision, time off, a retirement plan, and other voluntary benefits for employees.

Please apply to this position at the following link:

Elevar Therapeutics, Inc – Senior Director, Clinical Pharmacology – 23-163 (paylocity.com)

The Safety Scientist in the Drug Safety and Pharmacovigilance Department at Elevar Therapeutics is a key role in a highly visible position within the organization in the Safety Sciences Division. This individual is responsible for two key activities assuring patient safety: signal detection, and the efficient and timely and efficient processing of aggregate reports such as but not limited to DSURs. The signal detection process includes the assembly of the appropriate information, whether from clinical data, epidemiologic data, or toxicology data; drafting of the appropriate documents discussing the data and describing the analysis of the information regarding a potential signal; and then the communication of those documents to the appropriate Safety Management Team (as put forth in the CIOMS Working Group VI Report) and possible escalation within the organization. This paradigm will be followed whether products are in development or in the marketplace. The Safety Scientist will work in conjunction with the DSPV physician (also in the Safety Sciences Division) supporting assigned products. Also, this individual will draft or contribute to the appropriate documentation of the procedures followed in conducting safety surveillance and aggregate reporting either as SOPs or work instructions. Depending on experience, the Safety Scientist may serve as Head, Safety Sciences or may report into the Head of the division. A good knowledge of GCP and appropriate FDA/ICH guidance is expected. This is a remote-based position.

• The Safety Scientist, working with the Safety Officer(s) for assigned products, will drive signal detection and the compilation/analysis of aggregate reports in both clinical safety and post-marketing approval pharmacovigilance settings
• Contributing author to aggregate reports (DSUR, PBRER, PSUR) and IB; may be called upon to lead in the drafting of an aggregate report
• Member of Safety Review Team assessing safety data for safety signals and risk management
• Reports to the Head, Safety Sciences; the candidate may also be considered for Head, Safety Sciences, depending on managerial experience
• Performs routine and ad hoc safety surveillance activities, such as signal detection, literature review and risk management for one or more programs
• Serves as Secretary of Safety Management Teams for assigned products
• Participates in and prepares responses to health authorities
• Reviews and provides input on protocols, statistical analysis plans, CSRs and other clinical study-related documents

• Health care provider (MD, DO, PharmD, DDS, etc.) status preferred, experience acceptable
• Minimum of 5 years working in the role of pharmacovigilance scientist
• Experience working in small start-up environment required; experience working in large pharma preferred
• Strong knowledge of clinical development process
• Ability to prioritize multiple tasks and make deliverables
• Strong knowledge of drug approval process in the US and EU; knowledge of process in Latin America, Asia and Japan preferred
• Experience with working with contract service providers for case processing, aggregate reporting
• Experience with regulatory inspection readiness and company audits; excellent oral and written communication skills
• Ability to demonstrate Elevar’s core values by holding ourselves and each other accountable for the work we do, taking time to collaborate effectively while working remotely, making space for ingenuity in work and thought, and staying grounded in compassion

The anticipated annual base salary range for this role is $140,000 to $155,000. Final compensation depends on multiple factors including but not limited to, relevant experience, skillset, depth and breadth of knowledge, internal equity, and external market factors. Elevar Therapeutics is a rapidly growing biotech company that offers competitive wages and benefits package including medical, dental, vision, time off, a retirement plan, and other voluntary benefits for employees.

Please apply to this position at the following link:

Elevar Therapeutics, Inc – Safety Scientist – 23-164 (paylocity.com)