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Braveheart Bio · 12 hours ago

Senior Director, Program Management

San Francisco Bay Area

Full-time

Onsite

Director/Executive

12+ years exp

Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease. The Senior Director, Program Management will strategically drive the lead asset through Phase 3 clinical development, global regulatory submission, and launch preparedness while ensuring alignment and execution across various workstreams.

BiotechnologyLife ScienceTherapeutics

Hiring Manager

Erica Arkin

Responsibilities

Work with the leadership team to develop pipeline strategies and build high-performing teams that can deliver defined business solutions

Develop and deliver on project plans to guide programs while managing risk, contingencies and/or corrective actions

Lead and manage the project management function

Define and direct the technical approach to project management

Lead and provide effective project/program leadership of the development team to deliver high-quality projects/programs with clear boundaries and outcomes on time and within budget

Work in partnership with the Leadership Team to develop and implement overall project/program strategy

Align development plans across Regulatory, Clinical, R&D, Pharmacology-Toxicology and CMC

Interface with Regulatory Affairs to develop global regulatory strategy and plans

Provide cross-functional leadership for the strategic planning of integrated development plans for programs, starting at first-in-human through registration

Co-chair cross-functional project/program team meetings to ensure appropriate action plans are created and implemented

Set realistic yet aggressive timeframes for achieving objectives with team buy-in and alignment

Lead cross-functional project/program team(s) to prepare Target Product Profile and global development plan to deliver differentiated products, leveraging the scientific and medical leadership of the Leadership Team

Define and implement a communication strategy/plan for the program that supports the most effective team empowerment and progress

Act as an appropriate role model/coach/mentor to facilitate the success and development of individuals within the teams and the team as a whole

Qualification

Drug development experienceRegulatory submission readinessProject leadershipPMP certificationBiotech regulations knowledgeFlexible mindsetCommunication skillsTeam-oriented approach

Required

Minimum of a Bachelor's degree

Minimum of 12 years of relevant experience

Proven track record of experience in drug development, especially with project/program leadership of cross-functional teams

Demonstrated experience planning, managing and completing one or more large, complex project with teams of 30+ individuals, 18+ month duration and implementation cost of $20M+, engaging varied functional stakeholders

Experience leading programs through the complexity of Phase 3 and regulatory submission readiness

A strong understanding of the biotech drug development process and regulations

Strong written and verbal communication skills with a collaborative, team-oriented approach

Ability to thrive in a fast-paced, dynamic environment and remain comfortable with change and ambiguity

Flexible, proactive, and hands-on mindset with a roll-up-your-sleeves, can-do attitude

Preferred

Advanced degree (MBA, MS, PhD) will be considered in lieu of industry work experience

PMP certification

Expertise gained from working directly in an R&D functional domain (e.g., Research, Clinical, CMC, or Regulatory Affairs), combined with global team exposure and prior Project/Program Leadership experience, is highly desirable