Hybrid Associate Director, Clinical Pharmacology na Olema

About the Role >>> Associate Director, Clinical Pharmacology 

As the Associate Director of Clinical Pharmacology reporting to the Director of Clinical Pharmacology, you will actively contribute to the development and execution of clinical pharmacology and pharmacometrics strategies across the Olema portfolio.  You will participate in the design of clinical and relevant non-clinical studies and interpret, present, and report clinical/non-clinical study results. 

This is a fantastic opportunity for a driven Clinical Pharmacology professional to join a company with an industry leading Board of Directors and Management team and roll up their sleeves to build an innovative women’s oncology company with significant potential to transform breast cancer treatments.  

This role is based out of our San Francisco or Boston office and will require minimal travel. 

Your work will primarily encompass: 

• Working as part of the clinical pharmacology/pharmacometrics team and collaborating with other functions engaged in multiple clinical development programs as needed 
• Contributing to the authoring of clinical pharmacology sections of study synopses, protocols, study reports and regulatory documents including Investigator Brochures, EOP1/2 meetings, IND/NDA/IMPDs/sNDAs  
• Performing and reviewing non-compartmental analyses (NCA), including the creation of tables, figures and listings (TFL) and assisting with data management 
• Authoring pharmacokinetic (PK) sections in Clinical Study Reports, Regulatory Modules, and PK analysis plans and reporting
• Conducting preliminary/exploratory PK and PK/PD modeling analyses to help drive drug development decisions focused on oncology therapies  

And will also include: 

• Contributing to overall clinical PK/PD strategy to support all stages of drug development  
• Playing a key role in managing PK study operations with CROs and contracted vendors and proactively provide technical input on bioanalytical/quantitative issues 
• Reviewing clinical pharmacology regulatory publications to keep apprised of new regulatory developments/requirements and track recent regulatory approvals 
• Conducting quality control and quality assurance activities on datasets and reporting 
• Co/authoring peer-reviewed manuscripts and publications 
• Attending study team meetings and provide a unified clinical pharmacology position to Clinical, CMC, Regulatory and other cross-functional teams  

Ideal Candidate Profile >>> 

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. 

Knowledge: 

• Pharm. D and/or PhD degree with training and/or expertise in one or more areas related to pharmacometrics, clinical pharmacology or preclinical ADME studies or a Master's degree with extensive experience in Clinical Pharmacology
• Experience in clinical pharmacology, pharmacokinetic analysis, pharmacometrics and model-based drug development in a project team setting in academia or industry 
• Experience in moving compounds through the clinical trials processes and experience with various elements of clinical development and trial design and management and filings is preferred 
• Familiarity with the regulatory guidance's and design of small molecule clinical pharmacology clinical studies

Experience: 

• 8+ years of progressive industry or consulting experience (may be combined with academic research) working in R&D, pre-clinical and clinical environments 
• 5+ years of industry experience 
• Broad translational and clinical development expertise in small molecule drug development 
• Experience with PK/PD modeling with demonstrated quantitative skills   
• Understanding and/or application of a broad range of clinical pharmacology and quantitative tools including but not limited to WinNonLin, Phoenix, NONMEM, RStudio and other PK/PD analysis software
• Proficiency with MS Office products including Outlook, PowerPoint, Excel, and Word
• Demonstrated experience writing study reports and regulatory documents 
• Ability to work effectively both independently and collaboratively in a dynamic team-oriented environment, balancing multiple responsibilities, projects, and teams simultaneously 
• Ability to work well with external vendors and collaborators with courtesy and professionalism 
• Experience with small molecule oncology drug development and small molecule bioanalysis considered a plus  

Attributes: 

• Ability to prioritize and manage multiple concurrent tasks in a fast-paced deadline driven environment while delivering high quality results 
• Excellent written verbal and inter-personal communication skills and ability to adapt communication styles to varied internal and external partners  
• Perceptive listening skills and strong attention to detail 
• Adept at multi-tasking and problem solving 
• Self-motivated and enthusiastic; fast learner who can identify the core project challenges and expeditiously change course as required in a fast-paced organization 
• Teamwork and collaboration skills: Balances team and individual responsibilities; gives and welcomes feedback; puts success of team above own interests; supports everyone's efforts to succeed; shares expertise with others 
• Impeccable professional ethics, integrity, and judgment 

The base pay range for this position is expected to be $190,000 - $195,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

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