Head of Clinical Pharmacology
- Scholar Rock Inc.
- Full time
- Cambridge, Massachusetts
- Posted: February 10, 2023
Company
Scholar Rock is a Phase 3, clinical-stage biopharmaceutical company focused on the discovery and development of innovative medicines for the treatment of serious diseases in which signaling by protein growth factors plays a fundamental role.
Our most advanced investigational product candidate, apitegromab (SRK-015), a selective inhibitor of the activation of the growth factor myostatin in skeletal muscle, is in development for the treatment of spinal muscular atrophy, or SMA. Following positive results from the TOPAZ Phase 2 trial in patients with Type 2 and Type 3 SMA, we are now advancing apitegromab development through SAPPHIRE, an ongoing, randomized, double-blind, placebo-controlled, phase 3 clinical trial. In addition, we are conducting our DRAGON Phase 1 proof-of-concept trial for SRK-181, a selective inhibitor of latent TGFβ1 activation, in patients with locally advanced and metastatic solid tumors.
By combining our deep structural insights with antibody drug discovery, Scholar Rock is creating a pipeline of novel product candidates with the potential to transform the lives of patients suffering from a wide range of serious diseases, including neuromuscular disorders, cancer, and fibrosis.
Summary of Position:
The Head of Clinical Pharmacology, reporting to the CMO, will be a member of the development and medical leadership team. The successful candidate will be responsible for building and leading the clinical pharmacology capability at Scholar Rock, providing strategic and scientific leadership across all clinical portfolio in alignment with program strategy. The successful candidate will be an integral member of a cross-functional team involved in the development of integrated development plan. S/he will be accountable for analyses and interpretation of PK, PD, and efficacy data to guide the development of novel therapies across multiple therapeutic areas.
The work you'll be doing
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- Build and lead the clinical pharmacology capability, providing strategic and scientific leadership in the area of clinical pharmacology across all clinical portfolio from IND to Phase 4.
- Develop clinical pharmacology strategies for clinical programs across multiple programs at various stages of clinical development to enable global regulatory approval. Contribute to clinical protocol design, study execution, and data analysis.
- Lead the analyses, interpretation, and integration of clinical pharmacokinetic and pharmacodynamic data, including model-based simulation and exposure-efficacy relationship analysis for dose selection and optimization.
- Serve as subject matter expert to develop in-depth understanding of the relationship between clinical and preclinical findings to inform and refine clinical development strategy.
- Design and oversee the conduct of clinical pharmacology studies, either alone or as part of broader clinical trials, to generate high quality data to support registration.
- Provide clinical pharmacology expertise to help develop regulatory strategies for special populations (e.g., hepatic- or renally-impaired).
- Collaborate with bioanalytical and translational sciences team, including providing PK/PD analysis support, to deepen understanding of analytical methods and guide early drug development strategy.
- Lead and prepare clinical pharmacology sections of clinical protocols, investigator brochures, clinical study reports, and other clinical or regulatory (e.g., IND, BLA, MAA) documents.
The expertise we're looking for
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- PhD in pharmacokinetics or pharmacology
- A minimum of +10 years of experience in biopharmaceutical industry
- 7+ years of clinical development experience and proven track record of using clinical pharmacology to guide clinical trial development
- Proficient knowledge and hands-on experience in all aspects of clinical pharmacology, including modeling and simulation of pharmacokinetic, pharmacodynamic, and efficacy relationships, including expertise with population modeling.
- Ability to interpret and integrate complex data sets across multiple disciplines including pharmacology, DMPK, toxicology assessing the clinical relevance.
- Experience in global regulatory submissions and interactions.
- Strong interpersonal skills to work effectively in a team setting/matrix-type organization.
- Understands the drug development process from pre-IND through BLA
- Highly organized, outcome-oriented, self-motivated performer
The special traits of the ideal candidate
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- Energized by a vision to change the world through innovation (in both what we do and how we do it); a catalytic leader who strives to make that happen
- Integrity in thought and action, creativity, team-centric mindset, integrative thinking, ability to influence decision-making without dictating, exceptional communication skills, the ability to inspire, and being a “hands-on doer” who leads from the front, not a “politician or presider”
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.