Job Description

Lexington, Massachusetts, United States; Remote

At Keros, our mission is to deliver significant clinical benefit to a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta (TGF-) family of proteins. With a focus on developing differentiated product candidates that are designed to alter TGF- signaling, we aim to target the pathways critical for the growth, repair and maintenance of blood cells and a number of tissues, including bone, skeletal muscle, adipose and heart tissue. We believe our product candidates have the potential to unlock the full therapeutic benefits of modulating the TGF- superfamily and provide disease-modifying benefit to patients.

JOB SUMMARY: Keros seeks a Vice President / Executive Medical Director to lead the development of our neuromuscular asset. Reporting to the CMO, the VP/Executive Medical Director will serve as the clinical development leader for KER-065. She/he will serve as the lead physician in internal and external interactions with key stakeholders and will be the lead clinical development representative on internal project teams to support clinical studies from protocol development through study execution and completion of study reports. The VP/Executive Medical Director will collaborate with cross-functional team members, including Clinical Sciences, Clinical Operations, Program Management, Biostatistics and Data Management, Safety and Pharmacovigilance, DMPK/Clinical Pharmacology and CRO partners. The VP/Executive Medical Director will also lead and participate in meetings with academic study investigators and thought leaders, as well as in interactions with global health authorities. A genuine interest and understanding of the science supporting the pipeline, excellent leadership skills, an ability to work collaboratively in a highly matrixed, multidisciplinary team setting, and a commitment to developing new treatments for patients are critical for success.

Responsibilities:

• Serve as the lead physician and Development Leader and represent Clinical Development on Program and Project Strategy Teams for KER-065 in one or more indications.
• Collaborate with the Project Team Leader(s) and other team members to create and revise the Clinical Development Plan (CDP) for successful global regulatory approval and market access for one or more indications.
• Lead the design of scientifically rigorous clinical protocols that are aligned with the clinical development plan.
• Provide clinical development leadership on the timely delivery of the clinical program with attention to quality and scientific rigor.
• Lead and support the clinical components of key documents (e.g., Clinical Trial Protocols, Investigators Brochures, Clinical Study Reports (CSRs), regulatory documents including INDs/CTAs, BLAs/MAAs and regulatory responses) with high quality and consistency with the CDP.
• Oversee the Medical Monitor and work in concert with the Head of Safety to ensure continuous evaluation of drug safety profile, including safety monitoring of clinical studies and signal detection.
• Collaborate with biostatistics, clinical sciences, and other cross-functional team members to participate in relevant data analyses and presentations for safety monitoring committee meetings, regulatory documents, and internal reviews to support timely program decisions to achieve study objectives.
• Lead and/or participate in interactions with internal decision committees and external stakeholders including regulatory authorities, key thoughts leaders, data monitoring committees, advisory boards, and patient advocacy groups.
• Lead and participate in the periodic convocation of Steering Committee meetings.
• Work with the internal team and external stakeholders to develop and update key messages on disease states, MOA, target product profile, and scientific platform.
• Collaborate with Medical Affairs and other team members on the scientific communication of clinical data, including external messaging, publication planning, and congress management.
• Work with investigators, thought leaders, patient advocacy groups, and other external stakeholders, as appropriate, to foster scientific exchange, identify collaboration opportunities, recruit patients for clinical trials, and support commercial planning, including understanding of medical and health care practices.
• Represent the company as an organization and present data at advisory boards, investigator meetings, congresses, and other external venues.
• Author and review abstracts, posters, and manuscripts for publication.

Qualifications:

• MD or DO required, board certification/eligibility in neuromuscular and/or rare disease is highly desired.
• Minimum of 7 years Pharmaceutical/Biotech industry experience, including experience leading late-stage clinical trials and clinical development programs.
• Global clinical research experience and experience interacting with global health authorities is required; successful End-of-Phase 2 and/or NDA/BLA experience is highly desired.
• Deep understanding of clinical trial design, methodology, statistical concepts, protocol development and implementation, global regulatory submissions, and overall drug development.
• Knowledge of IND, End-of-Phase 2, and BLA/NDA processes.
• Track record of success in serving as a clinical development leader on cross-functional product teams.
• Experience with partnerships or responsibilities for interfacing with development and commercial partners.
• Outstanding leadership, problem-solving, organizational and communication skills.
• Ability to be in the company office at least 3 days per week (local candidates) or at least every 6 weeks (remote candidates) required.
• Ability to travel up to 20% required.

Our Diversity, Equity & Inclusion Mission Statement: Keros is an inclusive company. We believe that diversity drives innovation. We continue to build an inclusive culture that encourages, supports, and celebrates the diverse voices of our employees. As such, Keros takes a holistic approach in mentoring, coaching, and developing all of our Keros team members.

Keros Therapeutics is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.

Create a Job Alert

Interested in building your career at Keros Therapeutics? Get future opportunities sent straight to your email.

Apply for this job

*

indicates a required field

First Name *

Last Name *

Preferred First Name

Email *

Phone *

Resume/CV *

Enter manually

Accepted file types: pdf, doc, docx, txt, rtf

Enter manually

Accepted file types: pdf, doc, docx, txt, rtf

Education

School * Select...

Degree * Select...

Select...

Start date year

End date year

Location - City/State

LinkedIn Profile

What are your salary expectations? *

Are you open to relocation? * Select...

Will you now or in the future require sponsorship for employment visa status (e.g., H-1B visa status)? * Select...

How did you hear about us? * Select...

Referral specification:

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Keros Therapeuticss Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A disabled veteran is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A recently separated veteran means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An active duty wartime or campaign badge veteran means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An Armed forces service medal veteran means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Select...

Voluntary Self-Identification of Disability

Form CC]]> <

Job Tags

Similar Jobs