Director, Clinical Pharmacology - SpringWorks Therapeutics
Durham, NC
About the Job
About SpringWorks Therapeutics:
SpringWorks is a commercial-stage biopharmaceutical company applying a precision medicine approach to developing and delivering life-changing medicines for people with severe rare diseases and cancer.
SpringWorks has a diversified targeted oncology pipeline spanning solid tumors and hematological cancers, including clinical trials in rare tumor types and highly prevalent, genetically defined cancers. SpringWorks' strategic approach and operational excellence in clinical development have enabled it to rapidly advance its lead product candidates into late-stage trials and enter into multiple collaborations with innovators in industry and academia to unlock the full potential for its portfolio and create more solutions for patients with cancer.
About the Role:
The Director, Clinical Pharmacology will be responsible for supporting both clinical and nonclinical pharmacology activities at SpringWorks Therapeutics. This role includes working on clinical development teams to develop and implement the clinical pharmacology strategy, design clinical pharmacology studies, develop study protocols, and write clinical pharmacology study reports. This role will also involve working closely with internal clinical development teams, CROs, and study collaborators to file regulatory documents and execute clinical development plans. In addition, this role will also lead, manage, and develop other team members as direct reports and/or in a matrix management environment.
Location Classification – Hybrid:
This role will be required to work onsite 2 days a week (Tuesday and Wednesday), or more depending on business needs. #LI-Hybrid
OR
Location Classification – Remote:
Officially classified as working full-time from employee's home office within the United States or respected region, with the expectation to travel to SpringWorks Therapeutics offices or other locations on occasion as business needs
Key Responsibilities:
- Independently represent Clinical Pharmacology as a member of program, clinical sub-team, clinical trial working teams by contributing to clinical development strategy, clinical trial design, clinical study protocols, executing and coordinating clinical trial conduct and finalizing clinical study reports.
- Develop and execute program specific Clinical Pharmacology strategy and plan. Align plans with cross functional study and program teams.
- Design, conduct, and provide scientific interpretation of Clinical Pharmacology studies and provide effective Clinical Pharmacology support to patient trials. Lead internal sub-teams to define strategy for compound development.
- Actively participate in cross-departmental teams, company-wide initiatives and work streams.
- Work with external partners to provide Clinical Pharmacology support to new and ongoing studies.
- Manage CROs for DMPK and Clinical Pharmacology related studies and activities inclusive of developing and negotiating study timelines; ensuring accuracy of project delivery and pro-actively identifying hurdles and providing solutions.
- Partner with outsourcing management to coordinate vendor selection, proposal negotiation, and budgetary oversight as assigned.
- Co-author regulatory documents for submission to global health authorities, including eCTD sections for IND and NDA, Investigators Brochure (IB), and Briefing Documents.
- Lead, manage, and develop direct reports and other junior members of the clinical pharmacology team
- Perform other duties and responsibilities as assigned
Qualifications:
- Education: Advanced Degree in clinical pharmacology, pharmaceutical sciences, or related areas (e.g.: pharmacokinetics, pharmacology, drug metabolism or etc.). (PhD or PharmD preferred)
- 4+ years with Doctoral degree or 7+ years with Master's degree of relevant experience in clinical drug development in industry or academic/research.
- Experience formulating and executing Clinical Pharmacology strategies including design, interpretation and reporting of clinical pharmacology studies is required
- Direct interaction with the FDA and international regulatory authorities preferred Experience Bullet
- A working knowledge or previous experience with pharmacokinetic/pharmacodynamics, drug-drug interactions, PK/PD data management/analysis, and clinical development is a plus.
- Knowledge of ICH guidelines in the design, analysis, and interpretation of clinical pharmacology studies.
- Familiarity with related disciplines (e.g., bioanalysis, biostatistics, toxicology, regulatory affairs, clinical operations) in the drug development process.
- Broad familiarity with the drug development process and Model Informed Drug Development, particularly for oncology and/or rare disease is highly desirable as is prior experience working with CROs.
- Working knowledge of common tools for quantitative clinical pharmacology such as NONMEM, Monolix, R, WinNonlin, SimCYP, or GastroPlus. Ability to perform non-compartmental pharmacokinetic analysis (NCA). Expertise in PK/PD modeling is a plus but is not required.
- Knowledge or experience with developing biomarkers, targeted therapies or companion diagnostics..
- Embody the SpringWorks Values to act with empathy and humility to drive a culture that takes ownership and accountability for their individual and teams' performance.
- Strong interpersonal communication skills to collaborate with colleagues, stakeholders, and vendors effectively and clearly in a remote hybrid work environment.
- Ability to travel occasionally including overnight stay driven by business need.
Compensation:
The expected salary range for this position is $184,164.00 - $240,000.00. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.
We also offer a comprehensive benefits package for our team of SpringWorkers and their families, including competitive compensation, annual cash bonuses and equity grants, 401K matching, fully covered medical, dental, and vision plans, and a full week of holiday break at year end. It's the right thing to do – and helps us be healthy, happy, and at our best for the people who need us.
SpringWorks Leadership Principles:
- Change Steward - Recognize that change is essential; set goals that align to the Company's strategy and create positive momentum for change; adapt business practices as necessary to adjust to ever changing requirements
- Excellence Driver - Drive high performance and ownership through an open dialog; recognize performance, empower teams and create accountability for results
- Growth Coach - Set clear expectations, provide frequent feedback, coaching, and encourage continuous learning; leverage individual strengths to help SpringWorkers unleash their potential and grow in their jobs and careers
- Community Builder - Establish connections with others to build strong teams that trust each other and are great at collaborating to achieve goals; create a diverse, inclusive, and psychologically safe environment
DE&I:
We believe in fostering a culture of belonging. Explore how we are committed to DE&I
EEO Statement:
SpringWorks maintains an EEO Policy providing for equitable opportunities for employment and conditions of employment to all employees and applicants regardless of actual or perceived sex (including pregnancy, childbirth, breastfeeding or related medical conditions), gender, gender identity or gender expression, sexual orientation, partnership status, marital status, familial status, pregnancy status, race, color, national origin, ancestry, caste, religion, religious creed, age, alienage or citizenship status, veteran status, military status, physical or mental disability, past or present history of mental disorder, medical condition, AIDS/HIV status, sickle cell or hemoglobin C trait, genetic predisposition, genetic information, protected medical leaves, victims of domestic violence, stalking, or sex offense, political affiliation and any and all other characteristics or categories protected by applicable federal, state or local laws. SpringWorks treats all employees and applicants fairly in the selection process (and in other personnel activities) by giving all employees and applicants the same opportunities for employment. SpringWorks' Equal Employment Opportunity Policy is intended to ensure that there are no barriers that would prevent members of a protected group from a fair and equitable opportunity to be hired, promoted, or to otherwise take advantage of employment opportunities.
This Equal Employment Opportunity Policy applies to all aspects of employment, including, without limitation, recruitment, hiring, placement, job assignment, promotion, termination, transfer, leaves of absence, compensation, discipline, and access to benefits and training. Any violation of this Policy will result in disciplinary action up to and including termination of employment.
For more information see our Privacy Policy - Springworks (springworkstx.com)
