Senior Director, CMC Project Management

Posted 16 Days Ago
Be an Early Applicant
Foster City, CA, USA
In-Office
280K-305K Annually
Senior level
Healthtech • Biotech • Pharmaceutical
The Role
The Senior Director of CMC Project Management will lead the CMC program's strategic and operational activities, managing budgets, external partnerships, and cross-functional communications to achieve project goals.
Summary Generated by Built In

MISSION

Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we’re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.

POSITION SUMMARY

We are looking for a Senior Director of CMC Project Management who is upbeat, organized, self-motivated, collaborative, detail-oriented, and has a strong technical background and knowledge base.  The person filling this player/coach role will partner with the Head of Tech Ops, Biologics to provide strategic and operational leadership to the brelovitug CMC program, overseeing the development and implementation of integrated CMC plans from PPQ campaigns through global regulatory submission, approval, commercial launch, and lifecycle management activities. This role requires being able to prioritize to meet both short-term and long-term goals. This is a fantastic opportunity to make an impact, wear many hats, and be a part of an exciting growing biotech company.  This position is located in Foster City.

JOB FUNCTIONS/RESPONSIBILITIES

  • Manage program CMC budgets and related contracts, partnering with internal Finance and Contract functions.
  • Serve as the primary business lead for external partners, ensuring technical transfers,  manufacturing campaigns, testing, and other externally sourced activities stay on schedule and within budget.
  • Maintain dashboards and reporting mechanisms for program status, risks, decisions, and critical path updates for team and senior/executive leadership.
  • Facilitate cross-functional communications to gather inputs, align priorities, resolve conflicts, and share project updates; ensure clarity of owners, deliverables, and deadlines.
  • Maintain an integrated program timeline identifying critical decision points, governance reviews, team events, and key milestones.
  • Partner with Program Project Management to ensure appropriate integration with overall product strategy, timelines, and reporting, including alignment between development activities and portfolio-level planning as needed.
  • Support preparation for governance reviews and executive program presentations, ensuring materials are accurate, aligned, decision-oriented, and delivered on schedule.
  • Drive disciplined change control and documentation of scope/timeline changes, ensuring impacts are understood and communicated to stakeholders.

QUALIFICATIONS

Education /Experience:

  • Bachelor’s degree; advanced degree (M.S., Ph.D, or MBA) preferred.
  • At least 15+ years of work experience in the pharmaceutical/biotech industry with a significant focus on CMC project management for biologics.
  • Experience managing relationships with biologics CDMOs.
  • Able to effectively communicate updates, issues, and strategic solutions to problems.
  • PMP (Project Management Professional) or equivalent accreditation is desired.

KNOWLEDGE, SKILLS, AND ABILITIES

  • Strong interpersonal skills and ability to collaborate across functions; proven ability to influence without authority.
  • Strong PM fundamentals (meeting management, timeline/critical path management, risk and issue management, decision tracking, action management, governance preparation).
  • Proactive, forward-thinking, and able to anticipate needs in dynamic environments with competing priorities.
  • Exceptional facilitation and communication skills (including executive-ready written and presentation skills) with success influencing at all levels cross-functionally.
  • Strategic, able to identify long term needs and risks and to incorporate these into a long-term plan. Proven ability to make smart business decisions while balancing scientific, technical, and risk-based factors.
  • Highly collaborative with outstanding relationship-building skills; ability to lead teams, navigate ambiguity, and resolve conflict effectively.
  • Experience with project/portfolio management tools and systems and strong working knowledge of common collaboration tools (e.g., MS Office, Smartsheet, SharePoint).
  • Willing to travel and to participate in teleconferences during non-business hours.

The salary range for this position is $270,000 to $300,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee’s geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.

#LI-HYBRID

Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran’s status or any other classification protected by applicable State/Federal/Local laws.

Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.


Skills Required

  • 15+ years of work experience in the pharmaceutical/biotech industry
  • Significant focus on CMC project management for biologics
  • Experience managing relationships with biologics CDMOs
  • Bachelor's degree; advanced degree preferred
  • PMP or equivalent accreditation desired

Mirum Pharmaceuticals Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Mirum Pharmaceuticals and has not been reviewed or approved by Mirum Pharmaceuticals.

  • Equity Value & Accessibility Equity grants to new hires and an employee stock purchase plan make ownership more accessible and can boost total rewards when performance is strong. Public disclosures highlight frequent option/RSU inducements.
  • Healthcare Strength Comprehensive medical, dental, and vision coverage is employer-paid for employees, with added life, disability, and EAP support. This combination reduces financial burden and enhances overall wellbeing.
  • Leave & Time Off Breadth A broad time-off program includes multiple paid company holidays, a year-end shutdown, accrued vacation, and paid parental leave. This breadth provides additional rest periods beyond standard vacation.

Mirum Pharmaceuticals Insights

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The Company
HQ: Foster City, CA
200 Employees
Year Founded: 2018

What We Do

Mirum Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. Mirum’s approved medication is LIVMARLI® (maralixibat) oral solution which is approved in the U.S. for the treatment of cholestatic pruritus in patients with Alagille syndrome one year of age and older. Mirum’s late-stage pipeline includes two investigational treatments for debilitating liver diseases affecting children and adults. Maralixibat (LIVMARLI), an oral ileal bile acid transporter (IBAT) inhibitor, is currently being evaluated in clinical trials for pediatric liver diseases and includes the MARCH Phase 3 study for progressive familial intrahepatic cholestasis (PFIC) and the EMBARK Phase 2b study for patients with biliary atresia. In addition, Mirum has an expanded access program open in Canada, Australia, the UK and several countries in Europe for eligible patients with Alagille syndrome. Mirum has submitted a Marketing Authorization Application to the European Medicines Agency for maralixibat for the treatment of cholestatic liver disease in patients with Alagille syndrome. Mirum’s second investigational treatment, volixibat, also an oral IBAT inhibitor, is being evaluated in three potentially registrational studies including the OHANA Phase 2b study for pregnant women with intrahepatic cholestasis of pregnancy, VISTAS Phase 2b study for adults with primary sclerosing cholangitis, and the VANTAGE Phase 2b study for primary biliary cholangitis.

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