Susan Whitehead Email & Phone Number

BioSavvy Advisors, LLC., is a consulting firm offering fractional and interim leadership services, along with advisory and hands-on project support services to assist organizations facing multifaceted challenges, including:• Turnarounds, restructuring, and post-merger integrations• Establishing and optimizing project/program management capabilities• Providing operational guidance and support to achieve regulatory and corporate milestones• Assistance in building and enhancing Medical Affairs operations (including set up and oversight of compassionate use / expanded access programs)• Leadership coaching tailored for key personnel, particularly those wanting to adopt a more inclusive and effective leadership stylewww.biosavvyadvisors.com*Savvy BioPharma Consulting rebranded to BioSavvy Advisors in Jan 2024.

Oakland, Ca, Us

Managing a real estate portfolio and investing as a Limited Partner in impact venture funds focused in oncology, women's health and FemTech.

Bay Area Young Survivors (BAYS) is an inclusive breast cancer support community, providing vital support groups tailored to address the specific challenges faced by breast cancer survivors diagnosed at age 45 or younger. Services include providing resources to patients navigating treatment, fertility concerns, career and education disruptions, social isolation, and long-term survivorship challenges, along with bridging financial disparities.

Brighton, Ma, Us

HBR Advisory Council consists of invited-only business professionals to help shape content and provide insight to editors on leadership and management topics to share with the broader research community.

New Brunswick, Nj, Us

Phoenix, Arizona, Us

Selection Committee: Sept 2023 - PresentBreast Cancer Advisor: Nov 2023 - PresentThe CANCER FUND (CF) is an impact venture fund investing in early-stage companies developing cancer innovations that improve patient outcomes, expand access to care, and reduce the cost of care.

South San Francisco, California, Us

South San Francisco, California, Us

South San Francisco, California, Us

South San Francisco, California, Us

South San Francisco, California, Us

South San Francisco, California, Us

In this role, Susan:➣ Delivered consultancy services in drug development, medical affairs management, and regulatory submissions for multiple biotech and medical device firms across the US.➣ Engaged with key advocacy groups and secured their support on behalf of a client at an open public hearing for an Oncologic Drugs Advisory Committee (ODAC).

Bastrop, Texas, Us

Spearheaded strategic initiatives across PM, clinical operations, BD, and regulatory compliance functions, and progressed to assume a leadership role in building the Global Access Programs (GAP) business unit.KEY ACHIEVEMENTS★ Directed the team of ~10 FTEs and consultants in executing a comprehensive business model and upscaling plan to facilitate rapid growth for the GAP division (while holding full P&L accountability). ★ Designed a cost model - covering revenue, GP, overhead, fixed costs, and EBITDA - to provide multi-year revenue and EBITDA projections that would, in turn, facilitate informed investment decision-making by the Board and private equity investors.

South San Francisco, Ca, Us

➤ Got back behind-schedule Module 3 for new drug application (NDA) and marketing authorization application (MAA) back on track.➤ Patient Experience | Process Improvement | Program ManagementIn this role, Susan:➣ Turned around an underperforming Global Compassionate Use program through effective vendor management and day-to-day operational oversight.DELIVERED RESULTS➤ Increased the number of dosed patients (of compassionate use drugs) from 0 to 5.➤ Reduced turnaround time to 1 week for compassionate use approval to drug shipped to site and improved response time from site outreach to internal clinician review from 1 week to less than 24 hours.

Copenhagen, Capital Region, Dk

➤ Built the Project Management team and its operational infrastructure from the ground up.➤ Scenario Planning | Process Improvement | High-Performance Team Building | Project ManagementIn this role, Susan:➣ Turned around and fast-tracked behind-schedule Phase 3 prostate cancer vaccine study. Co-led an “enrollment rescue” initiative to get back on track.➣ Served on Core Development team as Head of Program Management for Cancer Immunotherapy Division (CID).➣ Enabled effective corporate scenario planning by designing an innovative portfolio planning tool. Facilitated accurate capture of clinical development timelines and related costs.DELIVERED RESULTS➤ Built the Project Management team and its operational infrastructure from the ground up. Provided high-caliber support to product development teams in prostate and colorectal cancer and early research development.

Paris, France, Fr

Leveraged expertise in late-stage drug development to provide critical operational advisory support to the CEO and oversaw program operations for a TNBC Phase 3 program, following the company’s acquisition by Sanofi-Aventis.

New Brunswick, Nj, Us

Led 100+ member multi-functional, multi-organizational team responsible for bringing a new DES product to market in the EU, US, Japan and emerging markets. Led program team from concept feasibility to OUS clinical trials in 13 months and led the development of an accelerated IDE submission testing strategy. Awarded Johnson & Johnson Encore Award ​for high performance.Responsible for managing up to $53MM annual budget.Championed PMO initiatives including Core Team Structure Roles & Responsibilities, generated Team Building Templates and led implementation of Stretch and Base Case Timelines to support growth and expansion of PMO within Cordis Franchise.Provided project management oversight of support for Operations and Process Engineering to build new commercial manufacturing facilities, working with outside vendors to manage construction timeline and day-to-day activities of key critical path deliverables for PAI & launch readiness.Experience in Design Control Stages from feasibility through commercialization.

New Brunswick, Nj, Us

Served as Project Management Lead responsible for managing timeline and deliverables for High Priority drug / device combination product during an NDA Resubmission, and US and MAA approvals. Awarded ALZA Special Award for outstanding project management leadership during an NDA resubmission & three ALZA Area Awards for exemplary leadership and professionalism during challenging situations.Responsibilities included oversight of early development (pre-clinical and Ph I) to full development (Ph III and Ph IV post approval commitments). Responsible for ensuring the timely execution on key critical path deliverables (i.e. IND, CTA and NDA deliverables) and managing the day-to-day project activities.Served as the project timeline, resource plans, and budget (scope >$20MM annual budget and 60 FTE headcount) subject matter expert.Served as the primary liaison with Johnson & Johnson Japan affiliate to help drive the Japan clinical and regulatory strategy.Led the clinical supply team resulting in improved processes for US, EU, and ALAMEWA. Selected as dept mentor for new hires within the department.