Director, Pharmaceutical Development

Erasca, Inc.; San Diego (CA); On-site; USD 215,000 - 240,000; Full time

Benefits offered by this job

Paid Time Off

Holiday

Sick Leave

Medical Insurance

Dental & Vision plans

Short-Term Disability

Long-Term Disability

Life/AD&D Insurance

FSAs/HSA/Commuter benefits

Critical Illness & Accident Coverage

Pet Insurance

Employee Assistance Program

401(k) with Erasca contribution

Employee Stock Purchase Program

Job summary

Erasca, Inc. in San Diego, CA, seeks a Director of Pharmaceutical Development to provide technical and strategic leadership for small molecule drug product development from early development through late-stage clinical development and registration.

The role oversees CDMOs for formulation, process development, clinical manufacturing, packaging, stability and validation. The ideal candidate will have 10–12+ years in biotech/pharma, strong ICH/cGMP knowledge, and the ability to influence across

Qualifications

• Advanced degree in pharmaceutics, chemistry or related field; highly preferred.
• 10–12+ years in biotech/pharma focused on small molecule drug product development and manufacturing.
• Experience managing relationships with CDMOs and knowledge of regulatory submissions.
• Familiarity with ICH guidelines and global cGMP requirements.
• Strong track record of scientific achievement and ability to influence without direct control.

Responsibilities

• Provide scientific and strategic leadership for design, development and manufacture of investigational drug products.
• Lead drug product development activities including formulation and process development, transfer, manufacturing, stability and validation.
• Manage relationships with CDMOs, contract labs and external partners.
• Collaborate with Process Development, Analytical Development, Regulatory CMC, QA, Supply Chain and others to meet objectives.
• Develop and execute CMC strategies to support development, registration and lifecycle management.
• Prepare, review and defend regulatory submissions and responses.
• Support health authority interactions, inspections and regulatory responses.
• Travel up to 25% domestically and internationally for meetings, transfers, audits and campaigns.

Skills

Leadership

CDMO management

Regulatory submissions

ICH guidelines

Cross-functional collaboration

Communication

Influence without authority

Education

Advanced degree in Pharmaceutics, Chemistry or related field

Job description

Erascais a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer. Our programs take novel approaches to shutting down one of cancer’s most commonly mutated signaling cascades, the RAS/MAPK pathway, which affects approximately 5.5 million lives each year worldwide. The name “Erasca” has an important embedded meaning: it is a contraction of our audacious hope to “erase cancer” that drives our mission and everything that we do on behalf of patients with cancer.

PositionSummary:

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, etc etera. In addition to base salary, the h ired 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.

• Paid Time Off
• Holiday
• Sick Leave
• Medical
• Dental and Vision Plans
• Short- and Long-Term Disability
• Basic and Voluntary Life/AD&DD Coverage
• Flexible Spending Account s (FSA , HSA, and Commute )
• Critical Illness and Accident Coverage
• Pet Insurance
• Employee Assistance Program
• 401(k) Plan with Erasca contribution
• the opportunity to participate in an E mployee S tock P urchase P rogram

Erasca, Inc., is an Equal Opportunity Employer and takes pride in maintaining a diverse and inclusive environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of sex , race, religion, national origin, ancestry, physical or mental disability, protected medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military and veteran status or any other basis protected by federal, state or local law or ordinance or regulation.