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Apogee Therapeutics

Apogee Therapeutics - Therapeutic Area Head – Respiratory

Remote - USA$395k - $425k+ Equity2d ago
RemoteStaffNAPharmaceuticalsBiotechnologySpeech TherapistPrincipalTraining DevelopmentReportingMentoringLaterPharmacovigilanceClinical TrialsRegulatory Affairs

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Requirements

• Board certified MD with expertise in respiratory and/or immunology drug development and experience across later stages of clinical development • 10+ years' biotech or pharmaceutical industry experience in a leadership role building and mentoring clinical development teams (MDs and non-MDs) • Passion for bringing better treatment options to patients and caregivers • Knowledge of clinical development strategies and trial execution for biologics and immunology therapeutics in the US and globally • Self-starter who will bring expertise and inspiration to the team, is able to multi-task in support of clinical development programs and has a growth mindset • Leads and works collaboratively with cross-functional teams in a fast-paced, hands-on and dynamic environment • Strong leadership, communication and presentation skills • Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless • Position requires approximately 25% travel including mandatory in-person attendance at All Hands meetings typically held twice per year, as well as team meetings, medical conferences, etc. • The anticipated salary range for candidates for this role will be $395,000 to $425,000 / year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.

Responsibilities

• Build, lead and mentor a team of Medical Directors and Clinical Scientists focused on Apogee’s respiratory portfolio, including monotherapy and combination therapies • Work cross-functionally with Program Leadership/Management, Biometrics, Medical Affairs, Clinical Pharmacology, Regulatory Affairs, Research & Translational Medicine, Commercial and other functions to develop the overall clinical development strategy in respiratory indications • Collaborate with Clinical Operations, Biometrics, Pharmacovigilance, and other functions to execute and successfully complete clinical trials across development phases leading to BLA filings and approvals • Help establish and maintain a network and relationships with respiratory experts, investigators and opinion leaders • Contribute to the scientific communication strategy of Apogee Therapeutics via publications, manuscripts, abstracts, posters and scientific presentations • Participate in medical review of adverse event reports and monitoring of incoming safety data in collaboration with pharmacovigilance, including evaluating and escalating safety signals • Coordinate and develop information for reports submitted to FDA, EMA, PMDA and government, regulatory, or partner agencies • Present to various external stakeholders - regulators, governing and harmonization bodies, principal investigators, scientific conference attendees, advisors and key opinion leaders • Maintain knowledge of clinical trial conduct to support operational needs for planning and executing clinical trials, including adherence to protocols, safety reviews, assay development, training, and clinical document review • Review and edit clinical study reports

Benefits

• A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless • Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly • Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits • We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave • Commitment to growing you professionally and providing access to resources to further your development • Apogee offers regular all team, in-person meetings to build relationships and problem solve • E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster.

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