Director Pharmaceutical Development

Position Summary: 

Reporting to the Executive Director, Pharmaceutical Development, the Director, Pharmaceutical Development will provide technical and strategic leadership for the development and manufacture of small molecule drug products from early development through late-stage clinical development and product registration. This individual will oversee and manage contract development and manufacturing organizations (CDMOs) supporting formulation development, process development, clinical manufacturing, packaging, stability, and validation activities. The Director will serve as the primary liaison for Erasca's drug product development and manufacturing programs, working closely with cross-functional partners in process development, analytical development, supply chain, quality assurance, and regulatory CMC to advance programs efficiently and compliantly. The Director will also support product registration activities through the preparation, review, and defense of CMC-related regulatory submissions and responses to health authorities.  

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 leadership for the design, development and manufacture of investigational drug products from preclinical development through clinical development and product registration.
• Lead drug product development activities, including formulation development, process development, process characterization, technology transfer, clinical manufacturing, packaging, stability studies, and validation activities.
• Manage technical activities and business relationships with contract development and manufacturing organizations (CDMOs), contract laboratories, and other external partners supporting development, manufacturing, stability, and validation programs.
• Collaborate effectively with Process Development, Analytical Development, Regulatory CMC, Quality Assurance, Supply Chain, Clinical Operations, and other functional groups to achieve program objectives and regulatory milestones.
• Develop and execute drug product CMC strategies to support clinical development, product registration, and lifecycle management objectives.
• Author, review, and approve development reports, technical documents, regulatory submissions (e.g., INDs, IMPDs, NDAs, MAAs, and related amendments and responses), and internal procedures.
• Support regulatory interactions, health authority responses, inspections, and product registration activities as needed.
• Act as a subject matter expert on drug product development and manufacturing, including GMP regulations, ICH guidance, pharmaceutical development principles, process validation, and current regulatory expectations.
• Travel up to 25% domestically and internationally to support internal meetings, CDMO oversight, technology transfers, manufacturing campaigns, audits, and other business activities.
• Perform all duties in accordance with company values, policies, and 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 commitment to 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.