72 Director-Sr Director Clinical Development - Pulmonary Focus - Remote Jobs in Seattle, WA
SORT BY
D
A
F
N
N
A
A
N
N
C
C
M
P
J
P
B
C
S
I
P
H
N
D
E
P
P
B
Director-Sr Director Clinical Development - Pulmonary Focus - Remote
$140k-180k (estimate)
Full Time | Business Services
3 Weeks Ago
NWRPros is Hiring a Remote Director-Sr Director Clinical Development - Pulmonary Focus - Remote
Position Overview:
Director/ Sr. Director, Clinical Development, is responsible for ensuring that from a clinical development perspective, the Company assets are aligned for success, leading up to launch. The Director/ Sr. Director, Clinical Development, does this by bringing together therapeutic area landscape knowledge, US and Global external expert insights, US/Global healthcare dynamics, understanding of the regulatory environment, and the clinical development experience to translate medical needs and gaps into an integrated strategic clinical development plan that enables the clinical development role in the Company’s overall market approach, while informing medical affairs efforts to support this goal.
Essential activities to be accomplished: collaborates cross functionally across within the Company functions such as Clinical Operations, Medical Affairs, Field Based Medical, Regulatory Affairs, and Market Access; creates, executes, measures, and adapts the clinical development strategy, including trial strategy and design; works with Medical Affairs to develop the appropriate communications for FBM, Patient Advocacy and Professional Relations, appropriate publication strategy and plans.
Key Responsibilities:
Director/ Sr. Director, Clinical Development, is responsible for ensuring that from a clinical development perspective, the Company assets are aligned for success, leading up to launch. The Director/ Sr. Director, Clinical Development, does this by bringing together therapeutic area landscape knowledge, US and Global external expert insights, US/Global healthcare dynamics, understanding of the regulatory environment, and the clinical development experience to translate medical needs and gaps into an integrated strategic clinical development plan that enables the clinical development role in the Company’s overall market approach, while informing medical affairs efforts to support this goal.
Essential activities to be accomplished: collaborates cross functionally across within the Company functions such as Clinical Operations, Medical Affairs, Field Based Medical, Regulatory Affairs, and Market Access; creates, executes, measures, and adapts the clinical development strategy, including trial strategy and design; works with Medical Affairs to develop the appropriate communications for FBM, Patient Advocacy and Professional Relations, appropriate publication strategy and plans.
Key Responsibilities:
- Cross collaborates with Sr. VP Clinical Development, VP Clinical Operations, VP Medical Affairs, and Sr. VP, Program Management to co-create the clinical development plan to ensure that market needs are met, including clinical trial design, clinical indication, choice of potential comparator, implementation of imaging and biomarker plan.
- Ensures external experts' and patient’s feedback and input to the overall clinical development plan and specific clinical protocols.
- Implements excellence in clinical development as well as the generation of a consolidated medical strategy and integrated evidence plan to address meaningful gaps internally and externally.
- Design the clinical development program taking into account the needs of patients, physicians, and payers. Oversees product development throughout the lifecycle from early clinical development through approval, launch and loss of exclusivity.
- Collaborates with Medical Affairs to promote synergies throughout the product lifecycle to ensure the success of launches and timely execution of prioritized evidence generation initiatives.
- Responsible for providing clinical development insights into the Target Product Profiles, Clinical Development Plans, Pediatric Investigational Plan, core Clinical Trial Protocols, Project Analysis and Data Management Plan, Investigator Brochure, Annual Safety Report / IND Safety Reports, preparation for the Milestones Start of Development, Proof of Clinical Principle, Release of Full Development, and input into regulatory strategies and labeling discussions.
- Provides medical input in regulatory meetings and contributes to the submission strategy, regulatory dossiers, and safety issues.
- Contributes to the development of advisory boards, adjudication committees and Safety Data Monitoring boards.
- Collaborates with Medical Affairs to support profile of external experts for Field Based Medicine interaction.
- History of a strong clinical and research background preferably in ILD, including IPF and PPF and pharmaceutical industry clinical development experience.
- MD/DO (5 years pharma exp. plus prior clinical exp.),
- APRN (5-8 years pharma exp. plus prior clinical exp.),
- PhD (8-10 years pharma exp.)
- Demonstrated experience in developing and executing clinical development plans, medical affairs strategy and tactics, business process improvement, product launch planning, and integrated evidence generation
- Deep scientific knowledge of the US/Global healthcare system and regulatory landscape, including the needs of providers, patients, payers, and caregivers
- Ability to collaborate and lead with executive presence, positively influence performance excellence, and encourage innovation across all US therapeutic areas and levels
- Ability to translate science into clinical patient value and operate within SOPs and working instructions
- Strong oral and written communication skills as well as the ability to present complex information to large scientific / academic audiences as well as to the media
- Strong understanding of the shifting healthcare environment, medical, pharmaceutical and payor market dynamics, portfolio growth
- Ability to manage multiple projects and identify risks in a fast-paced environment with a drive for results and sense of urgency to meet medical market needs
- Ability to travel as required by the nature of the role including conferences and KOL meetings
- Self-motivated, independent, and able to work effectively in a small team and fast-paced environment
Job Summary
JOB TYPE
Full Time
INDUSTRY
Business Services
SALARY
$140k-180k (estimate)
POST DATE
04/17/2024
EXPIRATION DATE
06/15/2024
WEBSITE
nwrpros.com
HEADQUARTERS
Coupeville, WA
SIZE
50 - 100
INDUSTRY
Business Services
Related Companies
Show more
Similar Jobs
Popular Articles
Top 10 Things to Avoid Putting on a Job Application
Read Article
How to Describe Your Education in a Resume
Read Article
How to Write a Memorable Cover Letter in 5 Ways
Read Article
4 Personal Finance Tips to Make During Job Transition
Read Article
4 Best Camera Setups for Interview
Read Article
Keeping a Job Search Journal: 9 Types of Journaling You Can Do
Read Article
