Global Development Product Lead (Sr Director)

JOB SUMMARY

 

·         Leads multiple (~1-3) cross functional oncology product teams from pre-clinical candidate nomination (CAN) through Phase 1-2 clinical development and proof of concept (POC) stages, at which point molecule may be handed to the late-stage Oncology Development team for post-POC (typically phase 3) development

·         In close collaboration with functional experts on the product teams, drives the effective integration of an end-to-end cross functional molecule strategy and risk mitigation plan and ensures delivery of data-driven milestones through successful risk identification and mitigation.

·         Support clinical trials and the development strategy for early development assets and lead development programs across multiple functions within Pfizer Oncology, as well as represent the program with the external clinical community.

·         Develop clinical development plan from first in human clinical trial to proof-of-concept, including assessment of appropriate combinations, as well as evaluation of potential predictive and pharmacodynamics biomarker plans.

·         To ensure the clinical components of the clinical plans and clinical expertise are provided to project teams, including medical monitoring of clinical trials. 

JOB RESPONSIBILITIES

• Lead, develop and execute strategic development for early development assets. Lead cross-functional teams in collaboration with line function experts on the Global Product Teams (GPTs) to develop and drive an integrated product plan that addresses near-term technical uncertainties and ensures alignment with future pivotal development and commercialization success.
• Ensure timely execution and delivery of product milestones within budget.
• Communicate with executive management and governance committees to address program needs and provide recommendations. Ensure clear and effective product presentations and communications.
• Collaborate with partners on co-development programs to deliver a shared global product strategy, when applicable.
• Lead the team to set objectives, prioritize tasks, and ensure adherence to the plan and strategy
•   Manage risk by proactively identifying and resolving issues and developing contingency plans
• Oversee early development assets’ development broadly within a specific indication or group of indications. Typically, work on at least two clinical programs and support the development and provide consultation regarding multiple research projects.
• Work across the organization and on multifunctional teams responsible for the development of early development assets (including Product Team, Global Development Team, and Study team).
• Oversee the development and management of clinical protocols and amendments, investigator brochures, clinical study reports, statistical analysis plan, and regulatory documents.
• Provide leadership to early stage clinical scientists on the clinical study team for Early Development Assets, working in a matrix team environment with other clinicians, statisticians, clinical pharmacologists, translational biologists and regulatory specialists. Meet regularly with Pfizer Oncology group leaders/surrogates across functions to increase mutual awareness and influence of emerging program targets, priorities and status.
• Implementation of PK-guided dose escalation, early combination strategies and emerging innovations on all Oncology R&D first-in-human clinical trials with input from Pfizer Oncology’s Oncology Research Unit, Regulatory Strategy, Clinical Pharmacology and Precision Medicine, Clinical Development and Operations, Pharm Sci and Product Teams.
• Oversee the evaluation of safety, pharmacology, and efficacy data from ongoing and completed studies for early development assets.
• Oversee manuscripts, abstracts and presentations for scientific meetings and advisory boards.
• Conduct literature reviews and prepare summaries to support clinical development programs.
• Medical resource for design and interpretation of clinical and preclinical programs to support existing and new development candidates.
• Coordinate regular (at least quarterly and as needed) interactions with preferred clinical trials network and KOL advisory board to objectively consider and implement feedback.
• Drive innovations in early clinical development, and the application of translational oncology and precision medicine approaches.
• Collaborates with cross-functional leaders and teams to translate early preclinical discovery research into therapeutic candidates.
• Coordinates with business development to establish strategic external collaborations and foster new research projects and programs.
• Contribute to broader organizational excellence as a member of the OESD department. Create a positive team environment that fosters trust, encourages the sharing of disconfirming information, and promotes clear and transparent communication to align the team around the overall goal and vision for the product.

QUALIFICATIONS / SKILLS

• MD or MD-PhD with 5+ years of industry experience required.
• Oncology drug development experience, track record in oncology clinical research including early phase drug development is preferred.
• Clinical oncology experience: Board certification in oncology preferred.
• Significant industry leadership experience in clinical, translational or basic research in biomedical sciences or one of the disciplines related to drug development.
• Understanding of related disciplines (e.g., biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences). 
• Demonstrated scientific productivity (publications, abstracts, etc.).
• Proven scientific writing skills and good communication skills.
• Proven leadership skills with ability to defend the clinical plan at governance meetings is essential.
• Capacity to adapt to a fast-paced and changing environment.
• Demonstrated history of effective leadership; including cross functional and matrixed teams, managing direct reports when applicable, and experience in seeking and maintaining alignment with cross-functional leaders
• Demonstrates a passion for helping patients with cancer and for the science of oncology.
• A proactive and strategic thinker, with strong data-driven decision-making skills
• Ability to focus and motivate a team in a matrix organization with multiple stakeholders
• Strong verbal, written, and presentation communication skills
• Experience in staff management with effective mentoring experience and skills
• Highly collaborative with outstanding relationship building skills with internal company leadership, external development partners and investigators/medical professionals
• Has a strong leadership presence and the ability to work effectively with other leaders.
• Is a team player, works well in a team environment both as a leader and a key contributor.
• Has a global perspective and mindset, with the ability to work effectively with colleagues from myriad cultures, backgrounds, and geographies

ORGANIZATIONAL RELATIONSHIPS

Early stage clinical scientists on the clinical study team for Early Development Assets, clinicians, statisticians, clinical pharmacologists, translational biologists, regulatory specialists, pharmaceutical sciences, commercial strategy representatives, and other Pfizer Oncology group leaders/surrogates across functions. In addition, chairs of strategic oversight committees (head of oncology early stage development + line function leaders on governance bodies), direct line managers of line function experts assigned to cross-functional molecule teams, governance committees and molecule development teams of contractual external development partners, and BD team including due diligence teams.

RESOURCES MANAGED

-          Manges individual product team annual clinical trial budget and projected operational plans for the coming years: $20-100M

-          This position does not manage direct reports

 
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

Relocation support may be available

Work Location Assignment:  This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week.

The annual base salary for this position ranges from $274,500.00 to $457,500.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 25.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

Candidates must be authorized to be employed in the U.S. by any employer.

U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.

Medical