Senior Director, Clinical Pharmacology

3 weeks ago

South San Francisco, California, United States Maze Therapeutics Full time

The Position:

At Maze Therapeutics, we are assembling a team of passionate, creative, and dedicated professionals to join us on our mission to turn groundbreaking genetic discoveries into life-saving medicines. We're looking for a Senior Director, Clinical Pharmacology to join our Clinical Science team and take a central role in pioneering the future of healthcare.

As the Senior Director, Clinical Pharmacology, you'll be at the forefront of translating genetic insights into innovative treatments for patients. Your work will help drive the early clinical development programs for game-changing therapies, starting with small molecules targeting novel drivers of chronic kidney disease.

Maze Therapeutics has an exciting pipeline focused on renal, cardiac, and metabolic diseases that will enter the clinic in the coming years. In short, you'll play a fundamental part in advancing medical breakthroughs that have the potential to transform many lives.

To succeed in this role, you'll need to thrive in a fast-paced, collaborative environment. As the Senior Director, Clinical Pharmacology across the Maze portfolio, you will partner closely with cross-functional leaders and team members to help design, conduct, and interpret the key clinical studies, including first-in-human, other clinical pharmacology and proof-of-concept patient trials. Your contributions will be highly visible and integral to the success of the Maze team.

Your Impact:

Generate and oversee the execution of the Clinical Pharmacology strategy for all development programs
Collaborate with In Vivo Pharmacology and DMPK on development of translational PKPD models
Serve as lead in design and analysis of FIH and other Phase 1 studies and participate in the design, execution, and analysis of other clinical trials for all clinical stage assets at Maze
Conduct compliant data analyses including noncompartmental analyses using validated software, modeling & simulation, literature data analyses
Co-author and review with cross-functional colleagues all clinical-regulatory documents, including IND/CTAs, clinical protocols and amendments, study reports, population PK reports, exposure-response analyses reports, relevant sections of investigator brochures, common technical documents, white papers and other similar documents
Investigate, identify, develop, and optimize new methods & techniques in the field of clinical pharmacology. Act as lead PKPD scientist at Maze and critically evaluate relevant clinical pharmacology and regulatory advances, and integrate this knowledge into research and development programs
Prepare and deliver scientific presentations and other communication materials for internal and external stakeholders, including investigators and other Maze collaborators
Partner with Clinical Development Operations and Vendor Management to identify, select, and oversee vendors and CROs to support program needs
Develop and integrate timelines and budgets for clinical pharmacology activities with overall company timelines and goals, in close coordination with project management, clinical science, CMC, DMPK, nonclinical development, regulatory affairs and other stakeholders

As a Senior Director, Clinical Pharmacology, we also expect our leaders to demonstrate the following Leadership Competencies:
Communication and Influence
Role models clear communication and open two-way conversations
Reinforces an environment where people feel heard and their opinions are valued
Inspires followership despite differing initial opinions.

Teamwork and Collaboration
Champions collaboration and connection across Maze.
Establishes team norms and expectations.
Seeks opportunities to spotlight team and individual contributions in public forums.

Execution and Results
Develops recommendations to seize on opportunities and mitigate obstacles that could impact long-term success.
Coaches others on resource management and work distribution/delegation.
Aligns work to Maze's strategy, mission, and vision.

Develop Others and Self
Develops staff capabilities to handle delegation of responsibilities.
Encourages staff to develop and execute personal stretch goals.
Identifies and recommends ways to increase inclusive leadership.

Skills and Qualifications:
PhD in Pharmacology and/or PharmD with a minimum of 6+ years of drug development industry experience specifically in clinical pharmacology, pharmacometrics and/or modeling and simulations.
Experience in the design and conduct of clinical trials and pharmacology data analysis and in nurturing relationships with CROs, consultants and other third
Experience preparing regulatory submissions for INDs, NDAs, and/or MAAs and answering regulatory queries.
Knowledge and good understanding of global regulatory guidelines for clinical pharmacology including requirements and current best practices for modeling, drug interaction assessment, intrinsic covariate evaluation, and pediatric study planning.
Exceptional organizational, analytical, and communication skills, enabling you to translate corporate objectives into actionable plans that consistently deliver high- quality data on time and within budget.
A positive and enthusiastic disposition, adaptability to changing environments, and unwavering personal and ethical standards in pursuit of corporate goals.
Ability to travel as needed for vendor visits, industry conferences, regulatory meetings, advisory boards and other essential gatherings.

About Maze Therapeutics

Maze Therapeutics is a biopharmaceutical company that is harnessing the power of human genetics to transform the lives of patients, with a focus on genetically informed therapies for common diseases such as chronic kidney disease. Maze applies variant functionalization in tandem with advanced data science methods and a robust suite of research and development capabilities to advance a pipeline of novel precision medicines. Maze has developed the Maze CompassTM Platform, a proprietary, purpose-built platform to understand and integrate the critical step of variant functionalization into each stage of drug development. Utilizing the Maze CompassTM Platform, Maze is building a broad portfolio of wholly owned and partnered programs. Maze is based in South San Francisco.

Our People

Maze is comprised of a team of passionate and creative professionals committed to discovering and delivering transformative medicines to patients suffering from both rare and common genetic diseases. We are fostering a culture that encourages vision, initiative and the development of talent. Our supportive work environment inspires creative thinking and freedom of expression, resulting in a stimulating atmosphere where people enjoy coming to work. While we have a passion for advanced science and pride ourselves on excellence in execution, ultimately, everything we do is about patients.

Our Core Values

Further Together – Our path is paved with challenges, but with resilience and a team-first mentality, we'll achieve our mission.

Impact Obsessed – We embrace the bold, take calculated risks, and learn from our mistakes to improve the lives of others.

Stand True – Our integrity is foundational; it guides us no matter the obstacle.

The expected annual salary range for employees located in the San Francisco Bay Area is $262,000 to $321,000. Additionally, this position is eligible for an annual performance bonus.

Maze performs position-based compensation benchmarking to industry market data to ensure we pay competitive wages. Determination of starting salary will depend upon a variety of job-related factors, which may include professional experience, skills, and job location. The expected salary range for this role may be modified in the future.

Maze offers a robust benefits package to our eligible employees including competitive medical, dental, and vision insurance, mental health offerings, equity incentive plan, 401(k) program with employer match and a generous holiday and PTO policy.

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