Senior Medical Director, Global Medical Affairs
Turning Point Therapeutics is a clinical-stage precision oncology company with a pipeline of internally discovered investigational drugs designed to address key limitations of existing cancer therapies. The company’s lead program, Repotrectinib, is a next-generation kinase inhibitor targeting genetic drivers of non-small cell lung cancer and advanced solid tumors. Turning Point Therapeutics is driven to develop therapies that mark a turning point for patients in their cancer treatment.
Turning Point Therapeutics is hiring a Senior Medical Director. The Senior Medical Director will be a member of the Global Medical Affairs (GMA) leadership team. This position will be responsible for managing and oversight of all medical aspects of the Turning Point Global Medical Research (GMR) program, including Investigator Sponsored Trials (ISTs) and other studies developed and managed by medical affairs (EAP, Phase 4, etc.). S/he will be responsible for the support, development, and execution of GMR plans and strategies including review of research proposals, protocols, and the overall AE and safety management for supported studies. Additionally, s/he will support the development and review of GMA content & materials, participation in advisory boards, publication plans, life cycle strategies, and operating plans. The Senior Medical Director will partner closely with the Head of Global Medical Affairs to develop integrated department strategies and plans for global support of repotrectinib and other Turning Point development assets.
DUTIES AND RESPONSIBILITIES:
These may include, but are not limited to:
- Elaborate on the current standard of care (SOC) for the target diseases by developing and executing GMR strategies (IST program, registry, other phase IV when needed) as well as performing opportunity and gap analyses in support of the overall Evidence Generation Plan
- Build and lead an operations team to execute and manage the evidence generation program
- Contribute to the development and execution of the GMA operating plan supporting a strong and efficient department infrastructure
- Support and participate at scientific and medical conferences, advisory boards and guidance committees
- Attend and contribute to relevant scientific and medical conferences to assist in strategy development and further develop Key Opinion Leader (KOL) interactions
- Provide medical support to GMA in developing publication strategy, reviewing and editing publications, posters, and presentations
- Lead the review of IST proposals in regional and global review meetings and oversee the scientific review of IST protocols; Lead the IST-related communication to key internal stakeholders in collaboration with the MSLs
- Lead the medical oversight of all AE and safety review and reporting of supported studies and in collaboration with the dedicated internal departments and teams
- Build on existing networks and establish relationships with KOLs and community Health Care Providers (HCPs); communicate and interact with MSLs and KOLs in a compliant and ethical manner in accordance with relevant SOPs
- Provide technical analysis and interpretation of data / issues that may have a potentially significant impact to medical and future commercial assessments
- Communicate existing and potential paradigm shifts in relevant cancer treatments and key competitors to guide future development strategies
- Participate in GMA, Commercial, Clinical and Drug safety teams as appropriate to repotrectinib and other Turning Point development assets
- Provide medical input and support in developing clinical, scientific, and future commercial strategies
- Proactively stay abreast of current developments within the pertinent disease areas
- Participate as needed in business development efforts related to medical and scientific due diligence evaluations of compounds, licensing and strategic collaboration opportunities as part of an integrated team
DESIRED SKILLS AND EXPERIENCE:
- MD preferred; other advanced medical degree (PharmD, PhD) with relevant experience may also be considered
- Minimum of 7 years of experience in the biotechnology, pharmaceutical or medical device industries, preferably in Medical Affairs and/or Clinical Development (equivalent combination of experience and education may be considered)
- Oncology experience essential
- Strong human and project leadership and management
- Strong leadership, team building, negotiation skills and ability to execute
- Solid understanding of drug development and product life-cycle development
- Demonstrated fluency in the fundamental underpinnings of cancer biology, therapeutic and supportive care medicines, clinical trial design and execution
- Proven ability to understand, interpret and explain scientific research and literature
- Understanding of government/industry guidelines and U.S. healthcare landscape (managed markets, emergence of evidence-based medicine, current regulatory environment, etc.) including, but not limited to, the Sunshine Act
- Experience with disease, product and market assessments related to business development opportunities an advantage
- Remain current on new developments in the fields of business strategy, development, hematology and oncology as they apply to the above functions
- Ability to effectively and diplomatically present ideas and document complex medical/clinical concepts
- Experience working in a cross-functional, matrixed environment both internally and externally
- Ability to manage multiple projects in a fast-paced environment
- Ability to work and influence in a cross-functional environment
- Well-spoken, confident, enthusiastic and charismatic
- Team player with ability to lead and collaborate with others to accomplish goals; adaptable to change
- Conduct business in accordance with the Mission and Values of Turning Point Therapeutics
- Travel may be required up to 40% of your time
As the Company is dedicated to its ambitious goals, it is imperative that he or she be first and foremost a team player. The successful individual will also possess many critical personal characteristics, including:
Excellent Communication Skills, both written and oral: The successful individual's communication style should be diplomatic and direct, but not confrontational. S/he must be able to articulate clear, tangible objectives for the organization and can deliver an honest assessment of the level of achievement of those goals. S/he must work well in a collaborative team environment.
Accountability: The successful candidate must be able to quickly energize the team and to focus it throughout its future growth stages. S/he should be a self-motivated, results oriented team player who leads by example, holds themself accountable for performance, takes absolute ownership, and champions the Company’s programs.
Indomitable Work and Teamwork Ethic: The successful candidate will reject setbacks and will enthusiastically persevere until ambitious goals are achieved, both personally and from a team perspective. S/he will be resourceful and innovative at tackling multiple challenges.
Entrepreneurship, sense of urgency: The successful candidate will react to situations quickly and decisively, possessing self-confidence to be assertive when taking a position, not being afraid to make decisions.
Integrity and Presence: The successful candidate will understand the importance of maintaining a high level of integrity. As such, s/he must project the appropriate professional image of the Company.
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.