Job Closed

This listing is no longer active.

Akero Therapeutics logo
Akero Therapeutics

Restoring Balance. Renewing Life.

Director, Clinical Development

DirectorDirectorOtherRemoteSeniorTeam 11-50Since 2017H1B No SponsorCompany SiteLinkedIn

Location

California

Posted

144 days ago

Salary

$181.7K - $317.9K / year

Seniority

Senior

Postgraduate Degree3 yrs expEnglishGCP

Job Description

Director, Clinical Development

Akero Therapeutics

• Play an active role in planning, conduct and evaluation of ongoing clinical trials to ensure successful execution • Serve as Medical Monitor for assigned clinical trials • Support/manage preparation of materials for trial-related clinical committees • Contribute to planning, authoring, and critical review of documents submitted to regulatory authorities • Contribute to the strategic planning, authoring, and critical review of scientific data disclosures • Develop professional relationships with external clinical opinion leaders, investigators, and consultants • Contribute to engagement with external stakeholders • Function as an independent member of the team and represent clinical development at internal cross-functional or external meetings • Other duties related to clinical development as assigned

Job Requirements

  • Board Certified MD or MD/PhD or equivalent qualification with relevant medical experience
  • Experience in hepatology, MASH or internal medicine preferred
  • Minimum of 3 years of relevant experience in clinical development in the biotech and/or pharmaceutical industry; five (5) years preferred
  • Direct experience in executing Phase III clinical trials, including medical monitoring responsibilities
  • Solid knowledge of GCP, ICH guidelines and FDA/EMA/CHMP regulations
  • Proven experience authoring or overseeing regulatory documents
  • Strong interpersonal and communication skills
  • Skilled at searching, critically evaluating, interpreting and synthesizing scientific literature and clinical trial data
  • Demonstrated problem-solving ability and ownership of issues
  • Comfortable working independently and as part of cross-functional teams
  • Highly organized with strong prioritization and time-management skills
  • Advanced proficiency in Microsoft Office (Word, Excel, PowerPoint)
  • Experience with preparation of documentation for BLA/NDA/MAA submissions desirable
  • Knowledge of the regulatory path across the various health authorities (FDA, EMA etc) desirable
  • Experience in Hepatology, Gastrointestinal, Endocrinology or related field, preferred.

Benefits

  • medical, dental and vision coverage
  • life insurance
  • disability insurance
  • 401(k) savings plan
  • flexible spending accounts
  • employee assistance program
  • tuition reimbursement program
  • voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance
  • time off pursuant to its sick time policy
  • flexible vacation policy
  • parental leave policy

Related Categories

Related Job Pages

More Director Jobs

Hudl logo

Director, Manufacturing – Program Delivery

Hudl

Performance analysis for sports at every level.

Director144 days ago
OtherRemoteTeam 1,001-5,000H1B Sponsor

• Establish and run the New Product Introduction (NPI) process • Partner with strategic sourcing leaders to manage ODM and JDM relationships • Empower a team of Technical Program Managers and Product Realization Leads • Align hardware and software schedules for program delivery and value creation

United States
$186K - $311K / year
Job Closed
Beyond Academy logo

Associate Director – Institutional Relations

Beyond Academy

Award-winning internships abroad 🌍 Top rated on GoAbroad & GoOverseas | 500+⭐ reviews #GoBeyond

Director144 days ago
OtherRemoteTeam 51-200H1B No Sponsor

• Expanding and deepening our network of institutional partnerships across the U.S. and other strategic markets. • Identify entry points within the higher education industry, develop and nurture long-term relationships with key decision-makers. • Represent Beyond Academy at major conferences and international education events. • Build and lead a team dedicated to managing and growing key institutional accounts.

Kansas + 1 moreAll locations: Kansas | Michigan
Job Closed
Malwarebytes logo

Director, Software

Malwarebytes

All-in-one cybersecurity that's always by your side.

Director144 days ago
OtherRemoteTeam 501-1,000Since 2008H1B Sponsor

• Lead a high-performance organization across multiple squads • Hire, mentor, and develop engineering managers and senior technical leaders • Build a high-performing engineering culture with a focus on quality and execution • Partner with Design and Product to deliver a modern, polished, and intuitive experience • Drive development of kernel drivers, behavioral detection, and AI-driven threat analysis • Establish engineering best practices, code quality standards, and testing strategies • Communicate progress, risks, and technical decisions to senior leadership

United States
Job Closed
The Lockwood Group logo

Executive Director, Business Development

The Lockwood Group

Lockwood collaborates with clients in the pharmaceutical, biotech, and medical device industries to identify effective, holistic, science-based strategies to address their objectives through medical communications. Our clients count on us to challenge their assumptions and help them creatively navigate around obstacles. From strategy through execution, we focus on accuracy, transparency, and scientific value to create programs that are evidence-based, clinically relevant, and contribute to the development of our clients’ brands. Over a third of our staff hold advanced scientific or medical degrees, and most work from where they live. Because our flexible structure provides better work-life balance, we attract the best talent, facilitate their best work, and as a result, are more responsive to our clients, wherever and whenever they do business.

Director144 days ago

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description Reporting into the Chief Business Officer, IDEOlogy Health is seeking an ambitious, experienced, results-oriented individual to drive business development activities of our rapidly growing medical media company. This individual should thrive in a fast-paced, startup mentality work environment and demonstrate a consistent ability to proactively identify and develop strategic growth opportunities, collaborate effectively across an organization, while able to develop an integrated customer engagement strategy to drive profitable revenue growth. Success in this position requires a strong understanding of sales, medical marketing, medical education, social media, oncology, and the biopharma industry including all regulations. Responsibilities - Lead sales for assigned customers, both current and potential. - Contact customers, prepare presentations, identify, and close sales opportunities, lead ongoing client status calls and projects. - Research client needs and create a solution that meets their objectives. - Liase with existing and new clients at conferences, virtual meetings, and face-to-face meetings. - Create a sales plan to achieve revenue goals with manager. - Provide ongoing sales pipeline metrics and plans to reach annual sales revenue target assigned. - Stay up-to-date on the oncology marketplace, developing lists of new prospects and lists of existing accounts for contact and/or follow-up purposes. - Lead all client contact and scheduling, and pipeline management. - Provide strategic input and direction to help guide the team on products and market trends. Qualifications - Bachelor’s Degree with at least 5+ years of proven experience in a similar role. - Pharmaceutical / Healthcare experience required. - Ability to demonstrate exceptional time management skills, manage projects, and meet deadlines. - Excellent written and verbal communication skills including the ability to communicate with senior level leaders within our organization as well as within client organizations. - Demonstrates a sound working knowledge of current role and the technical systems, applications, and equipment used in performing this role, and understands the impact this role has on other business functions within the organization. - Must be able to use time efficiently by prioritizing and planning work activities and events. - Demonstrates ability to make independent and sound decisions in all situations. - Sets high standards and measures of excellence to ensure quality assurance in every aspect of work performed. - Demonstrates effectiveness and flexibility with changing environments, responsibilities, tasks, and people. - Identifies and resolves issues in a timely manner and ability to act quickly to fix issues. - Proficient in all Microsoft Products, Zoom Meetings, and project management software. - Regular travel required.

United States
Job Closed