Director, Pharmaceutical Development

Erasca•San Diego, CA

1d•$215,000 - $240,000•Onsite

About The Position

Erasca is a clinical-stage precision oncology company focused on discovering, developing, and commercializing medicines for patients with cancer. The Director of Pharmaceutical Development provides technical oversight of contract development and manufacturing organizations (CDMOs) supporting small-molecule programs from research through clinical development and commercial production. Reporting to the Executive Director Pharmaceutical Development, this role serves as a liaison for manufacturing Erasca’s small-molecule drug products at external CDMOs and works with cross-functional colleagues in process development, analytical, formulation development, supply chain, quality assurance, and regulatory CMC. The Director also leads drug substance activities on one or more programs and independently manages projects. The position is based in San Diego, California. The ideal candidate is located in San Diego or is willing and able to travel there regularly. Up to 25% travel is required for internal meetings and collaboration in San Diego or South San Francisco, and for external activities nationally and internationally. The anticipated base salary range is $215,000 to $240,000. The successful candidate’s final salary will depend on factors including relevant experience and education. In addition to base salary, the position is eligible for an annual bonus and an equity grant at hire and annually in the form of an option to purchase stock at a specified price. Erasca describes its work environment as casual, collaborative, and fun and offers a comprehensive benefits package. Erasca is an Equal Opportunity Employer and is committed to maintaining a diverse and inclusive environment.

Requirements

10 to 12+ years of progressive experience in the biotechnology or pharmaceutical industry focused on small-molecule drug product development and manufacturing.
Experience managing relationships with contract manufacturing organizations.
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.
Strong track record of scientific achievement.
Demonstrated ability to influence without direct control.
Ability to build strong relationships with coworkers of varied backgrounds and expertise.
Ability to perform at a high level in a team setting as a manager, lead scientist, or individual contributor.
Demonstrated ability to achieve performance goals and meet deadlines in a fast-paced environment.
Effective interpersonal and communication skills, a collaborative approach, a can-do attitude, and ability to identify and implement creative solutions to complex technical problems.
Strong learning orientation, curiosity, and passion for science and patients.
Advanced degree in Pharmaceutics, Chemistry, or a related field is highly preferred; equivalent work experience and scientific credibility may be considered.

Nice To Haves

Experience with enabling technologies.
Experience with solid oral dosage form manufacturing.

Responsibilities

Provide scientific, technical, and strategic direction for the design, development, and manufacture of investigational drug products from preclinical and clinical stages through commercial stage.
Manage activities and contractual relationships with contract manufacturers and laboratories providing 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 drug product activities and provide strategic recommendations and status reports to cross-functional program teams.
Author, review, and/or approve development reports, regulatory submissions such as IND, IMPD, NDA, and MAA, and standard operating procedures.
Serve as a subject matter expert on GMP regulations, ICH guidance, and current regulatory expectations concerning drug product manufacture and process control.
Communicate effectively and contribute as a team player in a dynamic team culture.
Travel up to 25% for internal meetings and collaboration and external activities.
Perform duties in accordance with company core values, policies, and applicable regulations.
Lead drug substance activities on one or more programs and manage projects independently.