Turning Point Therapeutics is seeking a Senior Director/Executive Director of Clinical Development who will develop, lead and help drive the clinical development and overall R&D strategy of the company with the current SVP of Clinical Development. This person will be responsible for leading one or more Clinical Development programs and have key interactions with our future CMO and current CEO.
This individual will also be expected to cultivate relationships with key opinion leaders and serve as an outward-facing representative of the company to the medical and scientific community. The incumbent fulfills a critical and highly visible role, making substantial clinical and medical contributions to the company.
- Provide medical vision and clinical leadership for the strategy and plan to advance Turning Point’s platform and its current and future product portfolio to registration.
- Provide leadership and clinical perspective to the clinical development and comprehensive regulatory strategies.
- Manage the clinical development for lead programs including early development, clinical proof of concept, pivotal studies and regulatory submissions.
- Provide day-to-day practical and overarching strategic guidance for preclinical and clinical programs, ensuring that the design, implementation and conduct of the company’s clinical studies provide unambiguous data and information that allows for clear decision making and advancement of its developmental efforts.
- Represent Turning Point at the highest level at regulatory agencies with the team.
- Partner with the preclinical development team to shape and define the development strategy for early assets.
- Maintain understanding of competitors and clinical developments in relevant therapeutic areas by attending scientific meetings and tracking literature.
- Represent and manage the company’s clinical programs to diverse audiences including regulatory agencies, corporate partners, and other key stakeholders.
- Play a key role in medical meeting preparation and presentation. Build and foster relationships with medical and clinical communities, including the development of indication-specific Clinical Advisory Committees and other forms of strategic consultation. Represent Turning Point both internally and externally vis-à-vis the scientific and business communities including scientific conferences, presentations, industry and investors.
- Work closely with the business, commercial and regulatory functions to strategize drug development paths that seek to deliver timely regulatory approvals in areas of defined commercial merit.
- Build and maintain solid working relationships with key opinion leaders, and lead clinical investigators. Establish and foster relationships with the international scientific and medical community.
- Help identify clinical trial sites; working closely with, and supporting, Clinical Operations in site relationship activities as required.
- Actively assist in seeking product and/or technology alliances with appropriate pharmaceutical company partners to enhance/expedite the development of the company’s assets.
- Help to establish and maintain collaborations with partners in academia, government and industry.
- An MD or MD/PhD with strong leadership skills and proven biopharmaceutical industry experience in leading clinical development of early as well as mid-late stage therapeutic programs. 8 years minimum within the biopharmaceutical industry.
- A record of accomplishment including developing, planning, and designing clinical studies ideally leading to the successful registration of therapeutics.
- Experience with NDA/BLA submissions, ideally with oncology products, including formal interaction with regulatory agencies is preferred.
- Ability to forge solid personal and professional relationships with key opinion leaders is desired.
- Proven track record of excellent interpersonal and communication skills with ability to relate to both internal and external stakeholders, develop strong positive relationship with senior management and provide leadership and guidance to high functioning clinical and regulatory team.
- Experience presenting to a wide variety of audiences including internal teams, Board of Directors, medical and scientific communities.
- Experience in developing successful collaborations with academic and industrial partners.
- Solid management skills and a good reputation for managing others to succeed.
- Builder and leader of exceptional clinical science teams.
- Ability to operate effectively within an entrepreneurial and science-driven company environment.
- A self-motivated, assertive, driven and hands-on individual.
- Sophisticated scientific management skills and business judgment with an ability to evaluate alternatives, establish priorities and apply resources effectively.
- Strategic and analytical, with a real appreciation for the risk/benefit equation of the biotechnology enterprise.
- Strong judgment and decision-making skills in making critical go/no-go decisions.
- Recognized clinical R&D leader with a personal track record of innovation and a broad network of relationships in both academia and industry.
- Unquestionable integrity and highest ethical standards.
- Able to inspire people and stimulate creativity. Skilled at developing others and helping them navigate change and uncertainty.
- Exceptional interpersonal skills and a collaborative management style to facilitate interaction with partners, the CEO, management team and other colleagues across all levels.
- Strong external presence with excellent written and verbal communication skills.
- Sound project, financial, and operational management capabilities.
EEO & Employment Eligibility
Turning Point Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Turning Point Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Turning Point Therapeutics is an E-Verify employer.
To apply, please submit your resume to email@example.com