Director, Pharmaceutical Development

Position Summary: 

Reporting to the Executive Director Pharmaceutical Development, the Director of Pharmaceutical Development provides technical oversight of contract development and manufacturing organizations (CDMOs) for small molecule programs ranging from research phase to clinical development and eventually commercial production. This person will be a liaison for the manufacture of Erasca’s small molecule development drug products (DPs) at external contract development and manufacturing organizations (CDMOs) and will work on cross functional teams with colleagues from process development, analytical, formulation development, supply chain, QA, and regulatory CMC to plan, coordinate, and execute internal and external DP development and manufacturing activities. The Director of Pharmaceutical Development will also take a drug substance lead role on one or more programs and manage projects independently.  

Note that this position is based in San Diego, CA – the ideal candidate is in San Diego or willing and able to travel to San Diego on a regular basis.

Essential Duties and Responsibilities:

• Provide scientific, technical, and strategic direction to the design, development, and manufacture of investigational drug products from pre-clinical and clinical to commercial stage.
• Manage activities and contractual relationship with contract manufacturers and laboratories performing product and formulation development, manufacturing, analytical development and testing, stability, and validation services.
• Lead and collaborate with cross functional project team members to meet CMC goals.
• Represent CMC DP and provide strategic recommendations and status reporting to cross-functional program team.
• Author, review, and/or approve development reports, regulatory submissions (e.g., IND, IMPD, NDA, MAA), and SOPs.
• Act as Subject Matter Expert for knowledge of GMP regulations, ICH guidance, and current regulatory expectations regarding DP manufacture and process control.
• Function as a highly effective communicator and team player in a dynamic team culture.
• Up to 25% travel will be needed, to San Diego or South San Francisco for internal meetings and collaboration, and nationally and internationally for external activities.
• Perform all duties in keeping with the Company’s core values, policies and all applicable regulations.

Required Education, Experience and Attributes:

• Advanced degree in Pharmaceutics, Chemistry or related field is highly preferred, equivalent work experience and scientific credibility may be considered.
• 10 to 12+ years of progressive experience in the Biotech or Pharmaceutical industry focused on small molecule drug product development and manufacturing, experience in enabling technologies and solid oral dosage form manufacturing preferred.
• Experience managing relationships with contract manufacturing organizations including knowledge of small molecule drug product validation and experience with regulatory submissions.
• Familiarity with ICH guidelines and regulatory expectations relevant to drug development and cGMPs including regulations in multiple countries.
• A strong track record of scientific achievement.
• Demonstrated ability to influence without direct control.
• Ability to build strong relationships with co-workers of various backgrounds and expertise.
• Ability to function at a high level in a team setting whether as manager, lead scientist, or individual contributor.
• Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment.
• Effective interpersonal and communication skills; a collaborative team player with a can-do attitude and the ability to identify and implement creative solutions to complex technical problems.
• Strong learning orientation, curiosity, and passion for science and patients. 

 

The anticipated salary range for this position is $215,000 to $240,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etcetera. In addition to base salary, the hired applicant will be eligible to receive an annual bonus and an equity grant at hire and annually in the form of the option to purchase stock in the future for a specified price.