Vice-President, Early Development

American College of Clinical Pharmacology
Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Fulcrum's proprietary product engine identifies drug targets which can modulate gene expression to treat the known root cause of gene mis-expression. The company has advanced losmapimod to Phase 2 clinical development for the treatment of facioscapulohumeral muscular dystrophy (FSHD). Fulcrum has also advanced FTX-6058, a small molecule designed to increase expression of fetal hemoglobin for the treatment of sickle cell disease and beta thalassemia into Phase 1 clinical development.

Description

Fulcrum Therapeutics is pioneering small molecule therapeutic approaches to gene regulation in genetically defined rare diseases. The current opening is for a Vice-President Early Development with a minimum of 20 years of Pharmaceutical / Biotech experience.

Requirements

Essential Areas of Responsibility:

Reporting to the CSO, the successful candidate will play a key role shaping the future of Fulcrum Therapeutics by leading early development activities. The leader will be responsible for efforts across pre-clinical and early development, including pre-clinical pharmacology, translational science, toxicology, DMPK, and clinical pharmacology. As a key member of the Research Leadership Team, the VP Early Development will be responsible for leading a senior, multi-disciplinary team to progress programs from discovery into full clinical development. Key accountabilities include management of relationships with internal and external collaborators and partners, driving the creation of an internal alignment on early development plans across the organization and up to the Executive Team. Relevant activities that will contribute success metrics include, presenting scientific data internally and externally, authoring/reviewing study reports and regulatory documentation, contributing to high impact scientific manuscripts, identifying & managing external research collaborations, and engaging with scientific advisors and consultants. In this position, the leader will be expected to form effective, collaborative working relationships with others across multiple disciplines, attract key talent, mentor scientists and actively contribute to building Fulcrum's culture by exemplifying our core values.

Responsibilities:

Act as a technical and strategic cross-functional leader in the following:

Preclinical Pharmacology

• Lead a team of scientists focused on in vivo pharmacology and translational science.
• Collaborate with Medical Science to ensure that appropriate preclinical pharmacology and translational science strategies and assays are in place to support decision making on portfolio programs
• Create a strategic vision that enables the team to continually build for the future and remain state of the art.

Toxicology and ADME

• Strategic oversight of Toxicology and Drug Disposition functions. Act as a technical and strategic cross-functional leader.
• Develop plans to understand and work through issues that may be impeding the advancement of a compound or program.
• Partner effectively with relevant Discovery and Development functions (Clinical, Biology, Chemistry ). Assist in translating nonclinical to clinical data across pharmacology, ADME/PK, and toxicology/safety.
• Develop external network, including Identifying external KOLs to provide appropriate input into solving technical challenges.
• Participate in key decision making related to moving candidates forward, company strategy, and managing unanticipated challenges.
• Work with external collaborators, consultants, and partners in all aspects and stages of drug development.
• Drive activities needed to meet regulatory deadlines and company strategy timelines.

Clinical Pharmacology

• Build a highly effective, innovative clinical pharmacology group that can facilitate data driven decision making in the clinic and can support regulatory requirements for safety and efficacy
• Lead integration of preclinical and medical data analyses to guide development decisions
• Support and promote the use of leading edge methodology (e.g., quantitative pharmacology, synthetic control arms) to design efficient and effective clinical programs that maximize ability to make go/no go decisions while minimizing clinical exposure to experimental compounds.
• Support or lead, as possible, preparation of regulatory documents for health authority meetings, designations

Qualifications

• 20 years+ of drug discovery experience in pharmaceuticals/biotechnology
  • Expertise in small molecule drug discovery essential
• PhD is a relevant scientific discipline
• Experience leading and mentoring in a matrixed environment
• Experience leading cross-functional teams that advanced compounds into the clinic
• Proven ability to develop a vision and strategy to influence key stakeholders
• Strong external presence necessary
  • Ability to manage partnerships and external relationships
  • Ability to manage interactions with regulators

Job Information

• Job ID: 57178840
• Location:
  Cambridge, Massachusetts, United States
• Position Title: Vice-President, Early Development

Fulcrum Therapeutics is focused developing new medicines to deliver a new future for patients and their families by transforming gene regulation in disease. The Fulcrum product engine is based on the breakthrough biology of gene regulation. It will bring to bear medicines for devastating diseases across multiple therapeutic areas by modulating - or balancing - the expression of the genes known to drive disease. The Fulcrum product engine integrates insights from four scientific disciplines: Gene Regulation, Human Genetics a...

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